Postoperative PainNCT07527065
Comparison of TAP and QL Blocks for Postoperative Analgesia in Open Inguinal Hernia Repair
A study testing Transversus Abmoninis Plane Block and Quadro-Iliac Plane Block in people with Postoperative Pain, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Background Postoperative pain management after open inguinal hernia repair remains a clinical challenge despite spinal anesthesia. Ultrasound-guided fascial plane blocks, such as Transversus Abdominis Plane (TAP) block and Quadratus Lumborum Block (QLB), have been increasingly used as part of multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Transversus Abmoninis Plane Block and Quadro-Iliac Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Will undergo Open Inguinal Hernia Repair
- The American Society of Anesthesiologists (ASA) physical classification is 1-2.
- The volunteer has read and accepted the consent form
- Body mass index (BMI) <35
Who cannot join
- Body mass index (BMI) >35 kg/m²
- American Society of Anesthesiologists (ASA) physical status III-V
- Inability to assess pain using the Numeric Rating Scale (NRS)
- Known allergy to the local anesthetic or the planned analgesic agent
- Self-reported pregnancy or breastfeeding
- Age <18 or >65 years
Show all 21Show fewer
- Uncontrolled anxiety
- Alcohol or substance abuse
- Neuromuscular disease or peripheral neuropathy
- Use of high-dose opioid medication within three days prior to surgery widespread chronic pain
- Diabetes mellitus
- Hepatic or renal insufficiency
- Coagulation disorders
- Current use of anticoagulant therapy
- Infection at the site of peripheral block needle insertion
- Ireducible, incarcerated, strangulated, or recurrent inguinal hernia
- Inability to communicate in Turkish
- Technical problems during the use of the patient-controlled analgesia (PCA) device
- NRS score persistently above 7 for four consecutive hours despite the planned multimodal analgesia regimen
- Inability to understand or use the Verbal Rating Scale for pain assessment and the Quality of Recovery-15 (QoR-15) questionnaire
- Termination of surgery before completion for any reason.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hitit University Erol Olcok Training and Research Hospital,
Çorum, 19000
About this study
Official title: Comparison of the Postoperative Analgesic Efficacy of Ultrasound-Guided TAP Block and Quadratus Lumborum Block in Spinal Anaesthesia for Open Inguinal Hernia Repair
Background Postoperative pain management after open inguinal hernia repair remains a clinical challenge despite spinal anesthesia. Ultrasound-guided fascial plane blocks, such as Transversus Abdominis Plane (TAP) block and Quadratus Lumborum Block (QLB), have been increasingly used as part of multimodal analgesia. This study aimed to compare their effects on postoperative opioid consumption.
Methods After ethics committee approval, 70 patients aged 18-65 years with ASA I-II undergoing elective unilateral inguinal hernia repair were included in this prospective, randomized study. Patients were allocated into two groups: Group Q (QLB) and Group T (TAP). Blocks were performed preoperatively under ultrasound guidance using the in-plane technique with 30 mL of 0.25% bupivacaine. Block success was defined as sensory blockade at T10-L1 dermatomes at 30 minutes.
Read more
All patients received spinal anesthesia at the L3-L4 level with 12.5 mg of 0.5% isobaric bupivacaine. Postoperatively, patient-controlled analgesia (PCA) with tramadol was administered for 24 hours. Pain scores were assessed using the Numeric Rating Scale (NRS) at PACU and at 1, 3, 6, 12, 18, and 24 hours. Opioid consumption was recorded at 0-1, 2-12, 12-24 hours, and cumulatively over 24 hours. Postoperative side effects were also evaluated.
Results Both QLB and TAP block provided effective postoperative analgesia. There were no significant differences between the groups in terms of total 24-hour opioid consumption or NRS pain scores at measured time points. However, QLB demonstrated a trend toward prolonged analgesic duration and wider dermatomal spread.
Conclusion Both TAP and QLB are effective adjuncts to spinal anesthesia for postoperative analgesia in unilateral inguinal hernia repair. While QLB may offer broader and longer-lasting analgesia, its superiority over TAP block in reducing opioid consumption was not statistically significant.
Read the detailed description
Aim: Transversus abdominis plane (TAP) block has been shown to provide effective postoperative analgesia in open inguinal hernia surgeries. However, although there are studies reporting that the quadro-iliac plane block provides adequate analgesia in the lower abdomen, there is no study specifically investigating its use in open inguinal hernia repair cases. The aim of this study was to contribute to the literature by determining which method is more effective for postoperative analgesia after open inguinal hernia surgery and whether it reduces opioid-related complications.
Introduction Open inguinal hernia repair is a common surgical procedure that can be performed under general or regional anesthesia. Although considered minimally invasive, open inguinal hernia repair may cause moderate to severe postoperative pain and may even progress to chronic pain, which can be equally distressing. Incisional pain is the most important factor determining how soon patients can return to work after surgery. Postoperative chronic pain, with a reported incidence ranging % 10, is one of the major complications of surgical hernia repair . Severe pain may delay postoperative ambulation, reduce patient satisfaction, and contribute to the development of chronic pain; these conditions are also associated with increased pulmonary and cardiac complications. Moreover, inadequate pain control may prolong hospital stay.
Postoperative pain arises from multiple causes. In open inguinal hernia repair, the predominant pain experienced by patients is a combination of visceral and incisional pain. Postoperative pain is a common complication that may trigger a neuroendocrine stress response characterized by increased secretion of catabolic and immunosuppressive pituitary hormones and activation of the sympathetic nervous system . The use of regional anesthesia and analgesia as part of multimodal analgesia has been shown to reduce the neuroendocrine stress response associated with pain and surgical trauma. Therefore, pain management should be approached using multimodal analgesia.
To reduce postoperative pain following inguinal hernia repair, nonsteroidal anti-inflammatory drugs, paracetamol, opioids, local anesthetics, and various regional anesthesia techniques are commonly used. However, opioids may cause adverse effects such as postoperative nausea and vomiting, constipation, and respiratory depression. Multimodal analgesia techniques have been widely implemented in postoperative pain management . Truncal blocks-including the transversus abdominis plane block (TAPB), quadratus lumborum block (QLB), rectus sheath block, and hernia block-play an important role in multimodal analgesia.
The anterolateral abdominal wall consists of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles. The transversus abdominis plane is an anatomical plane located between the internal oblique and transversus abdominis muscles and contains the thoracolumbar nerves (T6-L1). The anterior and lateral abdominal walls are innervated by the anterior rami of the T7-T12 and L1 thoracoabdominal nerves. Therefore, injection of local anesthetic into the transversus abdominis plane provides sensory blockade from T7 to L1. The TAP block can be used as part of the analgesic regimen in various abdominal surgeries, including appendectomy, hernia repair, laparotomy, laparoscopic procedures, cesarean section, abdominal hysterectomy, pyloromyotomy, major abdominal wall surgery, and colostomy formation . In previous studies, Okur, Avelina, and colleagues demonstrated that TAP block provides superior analgesia in patients undergoing open inguinal hernia repair.
The quadro-iliac plane block (QIPB), first described in 2024 by Tulgar et al. , is a novel block technique intended to provide lumbosacral, abdominal, and hip analgesia. The target point of the QIPB lies between the internal iliac crest and the posterior surface of the quadratus lumborum (QL) muscle. Its anatomical spread has been shown to involve the posterior and anterior surfaces of the QL muscle, the transversalis fascia, the ilioinguinal, iliohypogastric, subcostal, and genitofemoral nerves, as well as the lumbar plexus. In subsequent case series by Atıcı, Güngör, Turan, and colleagues , QIPB was reported to provide both upper and lower abdominal blockade, as well as lumbosacral and sensory block.
Materials and Methods:
This study was designed as a prospective, randomized, double-blind observational study.
Patients will be informed about the procedure to be performed and written informed consent will be obtained from all participants. Patients included in the study will be randomly assigned to either Group T (Transversus Abdominis Plane Block) or Group Q (Quadro-Iliac Plane Block) according to a computer-generated randomization table prepared by a researcher not involved in the study.
To ensure blinding, each participant will be assigned a random code, and these codes will be placed in sealed envelopes. The anesthesiologist in the operating room will select the appropriate sealed envelope from a file, indicating the block to be performed for each randomized patient.
Methods Patients will be informed about the procedure to be performed, and written informed consent will be obtained from all participants. Patients included in the study will be randomly assigned to Group T or Group Q according to a computer-generated randomization table prepared by a researcher not involved in the study. To ensure blinding, each participant will be assigned a random code, and these codes will be placed in sealed envelopes. The anesthesiologist in the operating room will select the corresponding sealed envelope indicating the block to be performed for each randomized patient. The patient, surgeon, and personnel responsible for postoperative pain assessment will be blinded to group allocation.
Patients will be taken to the operating room or block area for peripheral nerve block administration. Standard anesthesia monitoring (noninvasive arterial blood pressure, heart rate, electrocardiography, and pulse oximetry) will be applied to all patients. Intravenous access will be established using a 20G catheter. Premedication will consist of midazolam 0.07-0.15 mg/kg and fentanyl 0.5 µg/kg. Supplemental oxygen will be administered via face mask. All block procedures will be performed under standard sterile conditions.
Transversus Abdominis Plane (TAP) Block With the patient in the supine position, the needle insertion site will be sterilized with 10% povidone-iodine. A linear ultrasound probe will be covered in a sterile manner. A 22-25G, 50-100 mm peripheral nerve block needle will be used. The ultrasound probe will be placed at the level of the umbilicus along the midaxillary line. After identifying the three abdominal muscle layers, the fascial plane between the internal oblique and transversus abdominis muscles will be visualized. The needle will be advanced using the in-plane technique (medial-to-lateral or lateral-to-medial). A total of 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the relevant muscle layers.
Quadro-Iliac Plane Block With the patient in the prone position, the needle insertion site will be sterilized with 10% povidone-iodine, and the linear ultrasound probe will be prepared in a sterile manner. The probe will be positioned to visualize the L3 spinous process at the midline. After slight lateral movement, the transverse process within the erector spinae muscle will be identified. When the probe is rotated sagittally and moved caudally, the iliac crest will be visualized. The erector spinae, quadratus lumborum, and psoas major muscles will be identified. The needle will be advanced in-plane from cranial to caudal. After hydrodissection with 2 mL of normal saline, 30 mL of 0.25% bupivacaine will be injected.
Following completion of the peripheral block, patients will be positioned sitting for spinal anesthesia. The L4-L5 intervertebral space will be identified using anatomical landmarks, and the insertion site will be sterilized with 10% povidone-iodine. Under sterile conditions, a 25G spinal needle will be inserted into the subarachnoid space. After confirmation of clear cerebrospinal fluid flow, 12.5 mg of 0.5% hyperbaric bupivacaine will be administered intrathecally over one minute. Motor block will be assessed using the Bromage scale (0 = no paralysis; 1 = unable to raise extended leg; 2 = unable to flex knee; 3 = complete paralysis). Surgery will commence when Bromage score 3 is achieved and sensory block reaches the T10 dermatome level.
During open inguinal hernia repair, intraoperative hemodynamic parameters will be recorded. Patients with an Aldrete score >9 will be transferred to the recovery room, where postoperative hemodynamic parameters will also be recorded.
Postoperative pain assessment will be performed by a ward nurse or anesthesiologist blinded to group allocation using the Numeric Rating Scale (NRS), a 0-10 scale (0 = no pain, 10 = worst imaginable pain). NRS scores at rest and during active movement (transition from supine to sitting position) will be recorded at 0, 1, 3, 6, 12, 18, and 24 hours postoperatively.
To determine the dermatomal level of sensory block, pinprick testing will be performed between T3 and L3 dermatomes at postoperative hours 2 and 24. The ilioinguinal and iliohypogastric nerves will be assessed 3-5 cm lateral to the midline and midaxillary line using a sterile needle. A three-point scale will be used (0 = no pain, 1 = decreased pain, 2 = normal pain), with scores of 0 or 1 considered effective. Sensation at the shoulder will serve as control.
For postoperative analgesia, all patients will receive intravenous paracetamol 1 g every 8 hours and intravenous tramadol via patient-controlled analgesia (PCA). The PCA protocol will consist of 10 mg tramadol bolus doses (maximum 300 mg/day), a 20-minute lockout interval, and no basal infusion. Tramadol consumption will be recorded at 0-1, 1-12, and 12-24 hours, as well as cumulatively over 24 hours.
Patients with NRS ≥4 will receive 25 µg intravenous fentanyl as rescue analgesia, and the number of administrations will be recorded. Time to first opioid requirement and total opioid consumption within the first 24 hours will be documented.
Postoperative nausea and vomiting (PONV) will be assessed using a four-point scale (1 = none; 2 = nausea only; 3 = single episode of vomiting or persistent nausea; 4 = ≥2 episodes of vomiting or severe retching). Patients with PONV score ≥2 will receive 4 mg intravenous ondansetron. Repeat doses will be administered at intervals of at least 4 hours if necessary. Total ondansetron consumption within 24 hours will be recorded.
Hemodynamic parameters (blood pressure and heart rate) will be recorded at 0, 1, 3, 6, 12, 18, and 24 hours postoperatively. The Quality of Recovery-15 (QoR-15) questionnaire will be administered twice: preoperatively in the waiting area on the morning of surgery and at 24 hours postoperatively. Patients will complete the Quality of Recovery-15 (QoR-15) questionnaire, a self-assessment survey that evaluates the quality of postoperative recovery in areas such as physical comfort, pain, independence, psychological support, and emotional state, both on the morning of surgery and 24 hours post-surgery. QoR-15 scores range from 0 to 150, with higher scores indicating better recovery quality. Demographic characteristics will be recorded preoperatively, and postoperative outcomes including time to first oral intake, time to first flatus/defecation, and time to first mobilization (unaided standing) will be documented.
- Conditions
- Postoperative Pain
- Being tested
- Transversus Abmoninis Plane Block, Quadro-Iliac Plane Block
- Keywords
- open inguinal hernia repair, postoperative pain, transversus abdominis plane block, quadro-iliac plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abmoninis Plane BlockProcedure or surgery
With the patient in the supine position, the needle insertion site will be sterilized with 10% povidone-iodine. A linear ultrasound probe will be covered in a sterile manner. A 22-25G, 50-100 mm peripheral nerve block needle will be used. The ultrasound probe will be placed at the level of the umbilicus along the midaxillary line. After identifying the three abdominal muscle layers, the fascial plane between the internal oblique and transversus abdominis muscles will be visualized. The needle will be advanced using the in-plane technique (medial-to-lateral or lateral-to-medial). A total of 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the relevant muscle layers.
Quadro-Iliac Plane BlockProcedure or surgery
With the patient in the prone position, the needle insertion site will be sterilized with 10% povidone-iodine, and the linear ultrasound probe will be prepared in a sterile manner. The probe will be positioned to visualize the L3 spinous process at the midline. After slight lateral movement, the transverse process within the erector spinae muscle will be identified. When the probe is rotated sagittally and moved caudally, the iliac crest will be visualized. The erector spinae, quadratus lumborum, and psoas major muscles will be identified. The needle will be advanced in-plane from cranial to caudal. After hydrodissection with 2 mL of normal saline, 30 mL of 0.25% bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Group T (Transversus Abmoninis Plane Block) | Active comparator | With the patient in the supine position, the needle insertion site will be sterilized with 10% povidone-iodine. A linear ultrasound probe will be covered in a sterile manner. A 22-25G, 50-100 mm peripheral nerve block needle will be used. The ultrasound probe will be placed at the level of the umbilicus along the midaxillary line. After identifying the three abdominal muscle layers, the fascial plane between the internal oblique and transversus abdominis muscles will be visualized. The needle will be advanced using the in-plane technique (medial-to-lateral or lateral-to-medial). A total of 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the relevant muscle layers. Receives: Procedure: Transversus Abmoninis Plane Block |
| Group Q ( Quadro-Iliac Plane Block) | Active comparator | With the patient in the prone position, the needle insertion site will be sterilized with 10% povidone-iodine, and the linear ultrasound probe will be prepared in a sterile manner. The probe will be positioned to visualize the L3 spinous process at the midline. After slight lateral movement, the transverse process within the erector spinae muscle will be identified. When the probe is rotated sagittally and moved caudally, the iliac crest will be visualized. The erector spinae, quadratus lumborum, and psoas major muscles will be identified. The needle will be advanced in-plane from cranial to caudal. After hydrodissection with 2 mL of normal saline, 30 mL of 0.25% bupivacaine will be injected. Receives: Procedure: Quadro-Iliac Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Examination with Numeric Rating Scale
Determination of patients' post-operative pain level. The Numeric Rating Scale (NRS), a method that converts the patient's pain perception into a numerical form, will be used to assess postoperative pain. NRS has a numerical scale ranging from 0 to 10. The patient will rate the intensity of pain on a scale from 0, indicating no pain, to 10, representing the worst imaginable pain (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and >8=intolerable pain). The NRS score will be evaluated both at rest and during active movement situations (such as transitioning from a lying to a sitting position).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start29 Sep 2025
- Primary completion10 Feb 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Kaya, Hitit University
- Investigators
- MEHMET YALVAÇ, MD, Principal investigator, Hitit University Faculty of MedicineZeynep Kaya, MD, Principal investigator, Hitit University Faculty of MedicineSerhat Özçiftçi, MD, Principal investigator, Hitit University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527065
- Sponsor's protocol ID
- 2025-149
- Other IDs
- M.D. MEHMET YALVAC
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mauricio Del Rio J, Nicoara A, Swaminathan M. Neuroendocrine stress response: implications for cardiac surgery-associated acute kidney injury. Rom J Anaesth Intensive Care. 2017 Apr;24(1):57-63. doi: 10.21454/rjaic.7518.241.hav.
PubMed 28913500Chakraborty A, Khemka R, Datta T. Ultrasound-guided truncal blocks: A new frontier in regional anaesthesia. Indian J Anaesth. 2016 Oct;60(10):703-711. doi: 10.4103/0019-5049.191665.
PubMed 27761032Gungor H, Ciftci B, Koruk I, Ince A, Yanaral T, Tulgar S. A novel and promising regional anesthesia technique in living-donor renal transplantation surgery: quadro-iliac plane block. Pain Med. 2024 Dec 1;25(12):797-798. doi: 10.1093/pm/pnae090. No abstract available.
PubMed 39259032Ciftci B, Tulgar S, Sakul BU, Alver S, Alici HA. Inspiring Use of Novel Blocks in Chronic Pain Management: Quadro-iliac Plane Block a Promising Step Toward the Future-A Case Report. A A Pract. 2024 Dec 12;18(12):e01886. doi: 10.1213/XAA.0000000000001886. eCollection 2024 Dec 1.
PubMed 39665467Turan EI, Aslan C, Berber K, Sarban O, Sahin AS. Efficacy of quadro-iliac plane block in single level lumbar discectomies: a case series for novel block. Minerva Anestesiol. 2024 Dec;90(12):1159-1160. doi: 10.23736/S0375-9393.24.18314-9. Epub 2024 Sep 11. No abstract available.
PubMed 39258831Turan EI, Sahin AS. Quadro-iliac plane block (QIPB) in lumbar stabilisation surgeries: A case series. Indian J Anaesth. 2025 Feb;69(2):244-245. doi: 10.4103/ija.ija_1077_24. Epub 2025 Jan 29. No abstract available.
PubMed 40160919Turan EI, Baydemir AE, Sahin AS. Efficacy of the quadro-iliac plane block in postoperative pain management for proximal femoral nail surgeries. Minerva Anestesiol. 2025 Mar;91(3):221-223. doi: 10.23736/S0375-9393.24.18506-9. Epub 2024 Nov 4. No abstract available.
PubMed 39495169Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Girit M, Akin T, Narayanan M, Alici HA. Ultrasound guided quadro-iliac plane block: another novel fascial plane block. Pain Med. 2024 May 3;25(6):370-373. doi: 10.1093/pm/pnae018.
PubMed 38459608Aveline C, Le Hetet H, Le Roux A, Vautier P, Cognet F, Vinet E, Tison C, Bonnet F. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. 2011 Mar;106(3):380-6. doi: 10.1093/bja/aeq363. Epub 2010 Dec 21.
PubMed 21177284Okur O, Karaduman D, Tekgul ZT, Koroglu N, Yildirim M. Posterior quadratus lumborum versus transversus abdominis plane block for inguinal hernia repair: a prospective randomized controlled study. Braz J Anesthesiol. 2021 Sep-Oct;71(5):505-510. doi: 10.1016/j.bjane.2020.11.004. Epub 2021 Feb 10.
PubMed 34537121O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.
PubMed 16418039Suresh S, Chan VW. Ultrasound guided transversus abdominis plane block in infants, children and adolescents: a simple procedural guidance for their performance. Paediatr Anaesth. 2009 Apr;19(4):296-9. doi: 10.1111/j.1460-9592.2009.02958.x.
PubMed 19335342McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
PubMed 17179269Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
PubMed 28759502Cevikkalp E, Erbuyun K, Erbuyun S, Ok G. Ultrasound guided transversus abdominis plane block. Postoperative analgesia in children with spinal dysraphism. Saudi Med J. 2018 Jan;39(1):92-96. doi: 10.15537/smj.2018.1.20943.
PubMed 29332115
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Efficacy of Ultrasound-Guided TAP Block and Quadratus Lumborum Block in Spinal Anaesthesia for Open Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT07527065
- Acronym / sponsor ID
- 2025-149
- Conditions
- Postoperative Pain
- Keywords
- open inguinal hernia repair, postoperative pain, transversus abdominis plane block, quadro-iliac plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Postoperative pain management after open inguinal hernia repair remains a clinical challenge despite spinal anesthesia. Ultrasound-guided fascial plane blocks, such as Transversus Abdominis Plane (TAP) block and Quadratus Lumborum Block (QLB), have been increasingly used as part of multimodal analgesia. This study aimed to compare their effects on postoperative opioid consumption.
Methods After ethics committee approval, 70 patients aged 18-65 years with ASA I-II undergoing elective unilateral inguinal hernia repair were included in this prospective, randomized study. Patients were allocated into two groups: Group Q (QLB) and Group T (TAP). Blocks were performed preoperatively under ultrasound guidance using the in-plane technique with 30 mL of 0.25% bupivacaine. Block success was defined as sensory blockade at T10-L1 dermatomes at 30 minutes.
All patients received spinal anesthesia at the L3-L4 level with 12.5 mg of 0.5% isobaric bupivacaine. Postoperatively, patient-controlled analgesia (PCA) with tramadol was administered for 24 hours. Pain scores were assessed using the Numeric Rating Scale (NRS) at PACU and at 1, 3, 6, 12, 18, and 24 hours. Opioid consumption was recorded at 0-1, 2-12, 12-24 hours, and cumulatively over 24 hours. Postoperative side effects were also evaluated.
Results Both QLB and TAP block provided effective postoperative analgesia. There were no significant differences between the groups in terms of total 24-hour opioid consumption or NRS pain scores at measured time points. However, QLB demonstrated a trend toward prolonged analgesic duration and wider dermatomal spread.
Conclusion Both TAP and QLB are effective adjuncts to spinal anesthesia for postoperative analgesia in unilateral inguinal hernia repair. While QLB may offer broader and longer-lasting analgesia, its superiority over TAP block in reducing opioid consumption was not statistically significant.
Detailed description
Aim: Transversus abdominis plane (TAP) block has been shown to provide effective postoperative analgesia in open inguinal hernia surgeries. However, although there are studies reporting that the quadro-iliac plane block provides adequate analgesia in the lower abdomen, there is no study specifically investigating its use in open inguinal hernia repair cases. The aim of this study was to contribute to the literature by determining which method is more effective for postoperative analgesia after open inguinal hernia surgery and whether it reduces opioid-related complications.
Introduction Open inguinal hernia repair is a common surgical procedure that can be performed under general or regional anesthesia. Although considered minimally invasive, open inguinal hernia repair may cause moderate to severe postoperative pain and may even progress to chronic pain, which can be equally distressing. Incisional pain is the most important factor determining how soon patients can return to work after surgery. Postoperative chronic pain, with a reported incidence ranging % 10, is one of the major complications of surgical hernia repair . Severe pain may delay postoperative ambulation, reduce patient satisfaction, and contribute to the development of chronic pain; these conditions are also associated with increased pulmonary and cardiac complications. Moreover, inadequate pain control may prolong hospital stay.
Postoperative pain arises from multiple causes. In open inguinal hernia repair, the predominant pain experienced by patients is a combination of visceral and incisional pain. Postoperative pain is a common complication that may trigger a neuroendocrine stress response characterized by increased secretion of catabolic and immunosuppressive pituitary hormones and activation of the sympathetic nervous system . The use of regional anesthesia and analgesia as part of multimodal analgesia has been shown to reduce the neuroendocrine stress response associated with pain and surgical trauma. Therefore, pain management should be approached using multimodal analgesia.
To reduce postoperative pain following inguinal hernia repair, nonsteroidal anti-inflammatory drugs, paracetamol, opioids, local anesthetics, and various regional anesthesia techniques are commonly used. However, opioids may cause adverse effects such as postoperative nausea and vomiting, constipation, and respiratory depression. Multimodal analgesia techniques have been widely implemented in postoperative pain management . Truncal blocks-including the transversus abdominis plane block (TAPB), quadratus lumborum block (QLB), rectus sheath block, and hernia block-play an important role in multimodal analgesia.
The anterolateral abdominal wall consists of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles. The transversus abdominis plane is an anatomical plane located between the internal oblique and transversus abdominis muscles and contains the thoracolumbar nerves (T6-L1). The anterior and lateral abdominal walls are innervated by the anterior rami of the T7-T12 and L1 thoracoabdominal nerves. Therefore, injection of local anesthetic into the transversus abdominis plane provides sensory blockade from T7 to L1. The TAP block can be used as part of the analgesic regimen in various abdominal surgeries, including appendectomy, hernia repair, laparotomy, laparoscopic procedures, cesarean section, abdominal hysterectomy, pyloromyotomy, major abdominal wall surgery, and colostomy formation . In previous studies, Okur, Avelina, and colleagues demonstrated that TAP block provides superior analgesia in patients undergoing open inguinal hernia repair.
The quadro-iliac plane block (QIPB), first described in 2024 by Tulgar et al. , is a novel block technique intended to provide lumbosacral, abdominal, and hip analgesia. The target point of the QIPB lies between the internal iliac crest and the posterior surface of the quadratus lumborum (QL) muscle. Its anatomical spread has been shown to involve the posterior and anterior surfaces of the QL muscle, the transversalis fascia, the ilioinguinal, iliohypogastric, subcostal, and genitofemoral nerves, as well as the lumbar plexus. In subsequent case series by Atıcı, Güngör, Turan, and colleagues , QIPB was reported to provide both upper and lower abdominal blockade, as well as lumbosacral and sensory block.
Materials and Methods:
This study was designed as a prospective, randomized, double-blind observational study.
Patients will be informed about the procedure to be performed and written informed consent will be obtained from all participants. Patients included in the study will be randomly assigned to either Group T (Transversus Abdominis Plane Block) or Group Q (Quadro-Iliac Plane Block) according to a computer-generated randomization table prepared by a researcher not involved in the study.
To ensure blinding, each participant will be assigned a random code, and these codes will be placed in sealed envelopes. The anesthesiologist in the operating room will select the appropriate sealed envelope from a file, indicating the block to be performed for each randomized patient.
Methods Patients will be informed about the procedure to be performed, and written informed consent will be obtained from all participants. Patients included in the study will be randomly assigned to Group T or Group Q according to a computer-generated randomization table prepared by a researcher not involved in the study. To ensure blinding, each participant will be assigned a random code, and these codes will be placed in sealed envelopes. The anesthesiologist in the operating room will select the corresponding sealed envelope indicating the block to be performed for each randomized patient. The patient, surgeon, and personnel responsible for postoperative pain assessment will be blinded to group allocation.
Patients will be taken to the operating room or block area for peripheral nerve block administration. Standard anesthesia monitoring (noninvasive arterial blood pressure, heart rate, electrocardiography, and pulse oximetry) will be applied to all patients. Intravenous access will be established using a 20G catheter. Premedication will consist of midazolam 0.07-0.15 mg/kg and fentanyl 0.5 µg/kg. Supplemental oxygen will be administered via face mask. All block procedures will be performed under standard sterile conditions.
Transversus Abdominis Plane (TAP) Block With the patient in the supine position, the needle insertion site will be sterilized with 10% povidone-iodine. A linear ultrasound probe will be covered in a sterile manner. A 22-25G, 50-100 mm peripheral nerve block needle will be used. The ultrasound probe will be placed at the level of the umbilicus along the midaxillary line. After identifying the three abdominal muscle layers, the fascial plane between the internal oblique and transversus abdominis muscles will be visualized. The needle will be advanced using the in-plane technique (medial-to-lateral or lateral-to-medial). A total of 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the relevant muscle layers.
Quadro-Iliac Plane Block With the patient in the prone position, the needle insertion site will be sterilized with 10% povidone-iodine, and the linear ultrasound probe will be prepared in a sterile manner. The probe will be positioned to visualize the L3 spinous process at the midline. After slight lateral movement, the transverse process within the erector spinae muscle will be identified. When the probe is rotated sagittally and moved caudally, the iliac crest will be visualized. The erector spinae, quadratus lumborum, and psoas major muscles will be identified. The needle will be advanced in-plane from cranial to caudal. After hydrodissection with 2 mL of normal saline, 30 mL of 0.25% bupivacaine will be injected.
Following completion of the peripheral block, patients will be positioned sitting for spinal anesthesia. The L4-L5 intervertebral space will be identified using anatomical landmarks, and the insertion site will be sterilized with 10% povidone-iodine. Under sterile conditions, a 25G spinal needle will be inserted into the subarachnoid space. After confirmation of clear cerebrospinal fluid flow, 12.5 mg of 0.5% hyperbaric bupivacaine will be administered intrathecally over one minute. Motor block will be assessed using the Bromage scale (0 = no paralysis; 1 = unable to raise extended leg; 2 = unable to flex knee; 3 = complete paralysis). Surgery will commence when Bromage score 3 is achieved and sensory block reaches the T10 dermatome level.
During open inguinal hernia repair, intraoperative hemodynamic parameters will be recorded. Patients with an Aldrete score >9 will be transferred to the recovery room, where postoperative hemodynamic parameters will also be recorded.
Postoperative pain assessment will be performed by a ward nurse or anesthesiologist blinded to group allocation using the Numeric Rating Scale (NRS), a 0-10 scale (0 = no pain, 10 = worst imaginable pain). NRS scores at rest and during active movement (transition from supine to sitting position) will be recorded at 0, 1, 3, 6, 12, 18, and 24 hours postoperatively.
To determine the dermatomal level of sensory block, pinprick testing will be performed between T3 and L3 dermatomes at postoperative hours 2 and 24. The ilioinguinal and iliohypogastric nerves will be assessed 3-5 cm lateral to the midline and midaxillary line using a sterile needle. A three-point scale will be used (0 = no pain, 1 = decreased pain, 2 = normal pain), with scores of 0 or 1 considered effective. Sensation at the shoulder will serve as control.
For postoperative analgesia, all patients will receive intravenous paracetamol 1 g every 8 hours and intravenous tramadol via patient-controlled analgesia (PCA). The PCA protocol will consist of 10 mg tramadol bolus doses (maximum 300 mg/day), a 20-minute lockout interval, and no basal infusion. Tramadol consumption will be recorded at 0-1, 1-12, and 12-24 hours, as well as cumulatively over 24 hours.
Patients with NRS ≥4 will receive 25 µg intravenous fentanyl as rescue analgesia, and the number of administrations will be recorded. Time to first opioid requirement and total opioid consumption within the first 24 hours will be documented.
Postoperative nausea and vomiting (PONV) will be assessed using a four-point scale (1 = none; 2 = nausea only; 3 = single episode of vomiting or persistent nausea; 4 = ≥2 episodes of vomiting or severe retching). Patients with PONV score ≥2 will receive 4 mg intravenous ondansetron. Repeat doses will be administered at intervals of at least 4 hours if necessary. Total ondansetron consumption within 24 hours will be recorded.
Hemodynamic parameters (blood pressure and heart rate) will be recorded at 0, 1, 3, 6, 12, 18, and 24 hours postoperatively. The Quality of Recovery-15 (QoR-15) questionnaire will be administered twice: preoperatively in the waiting area on the morning of surgery and at 24 hours postoperatively. Patients will complete the Quality of Recovery-15 (QoR-15) questionnaire, a self-assessment survey that evaluates the quality of postoperative recovery in areas such as physical comfort, pain, independence, psychological support, and emotional state, both on the morning of surgery and 24 hours post-surgery. QoR-15 scores range from 0 to 150, with higher scores indicating better recovery quality. Demographic characteristics will be recorded preoperatively, and postoperative outcomes including time to first oral intake, time to first flatus/defecation, and time to first mobilization (unaided standing) will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T (Transversus Abmoninis Plane Block) | Active comparator | Procedure: Transversus Abmoninis Plane BlockWith the patient in the supine position, the needle insertion site will be sterilized with 10% povidone-iodine. A linear ultrasound probe will be covered in a sterile manner. A 22-25G, 50-100 mm peripheral nerve block needle will be used. The ultrasound probe will be placed at the level of the umbilicus along the midaxillary line. After identifying the three abdominal muscle layers, the fascial plane between the internal oblique and transversus abdominis muscles will be visualized. The needle will be advanced using the in-plane technique (medial-to-lateral or lateral-to-medial). A total of 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the relevant muscle layers. |
| Group Q ( Quadro-Iliac Plane Block) | Active comparator | Procedure: Quadro-Iliac Plane BlockWith the patient in the prone position, the needle insertion site will be sterilized with 10% povidone-iodine, and the linear ultrasound probe will be prepared in a sterile manner. The probe will be positioned to visualize the L3 spinous process at the midline. After slight lateral movement, the transverse process within the erector spinae muscle will be identified. When the probe is rotated sagittally and moved caudally, the iliac crest will be visualized. The erector spinae, quadratus lumborum, and psoas major muscles will be identified. The needle will be advanced in-plane from cranial to caudal. After hydrodissection with 2 mL of normal saline, 30 mL of 0.25% bupivacaine will be injected. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Will undergo Open Inguinal Hernia Repair
- The American Society of Anesthesiologists (ASA) physical classification is 1-2.
- The volunteer has read and accepted the consent form
- Body mass index (BMI) <35
Key exclusion criteria (21 listed)
- Body mass index (BMI) >35 kg/m²
- American Society of Anesthesiologists (ASA) physical status III-V
- Inability to assess pain using the Numeric Rating Scale (NRS)
- Known allergy to the local anesthetic or the planned analgesic agent
- Self-reported pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus Abmoninis Plane BlockWith the patient in the supine position, the needle insertion site will be sterilized with 10% povidone-iodine. A linear ultrasound probe will be covered in a sterile manner. A 22-25G, 50-100 mm peripheral nerve block needle will be used. The ultrasound probe will be placed at the level of the umbilicus along the midaxillary line. After identifying the three abdominal muscle layers, the fascial plane between the internal oblique and transversus abdominis muscles will be visualized. The needle will be advanced using the in-plane technique (medial-to-lateral or lateral-to-medial). A total of 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the relevant muscle layers. | Procedure or surgery | Group T (Transversus Abmoninis Plane Block) |
| Quadro-Iliac Plane BlockWith the patient in the prone position, the needle insertion site will be sterilized with 10% povidone-iodine, and the linear ultrasound probe will be prepared in a sterile manner. The probe will be positioned to visualize the L3 spinous process at the midline. After slight lateral movement, the transverse process within the erector spinae muscle will be identified. When the probe is rotated sagittally and moved caudally, the iliac crest will be visualized. The erector spinae, quadratus lumborum, and psoas major muscles will be identified. The needle will be advanced in-plane from cranial to caudal. After hydrodissection with 2 mL of normal saline, 30 mL of 0.25% bupivacaine will be injected. | Procedure or surgery | Group Q ( Quadro-Iliac Plane Block) |
Primary outcome
Postoperative Pain Examination with Numeric Rating Scale
Time frame: 24 hours
Determination of patients' post-operative pain level. The Numeric Rating Scale (NRS), a method that converts the patient's pain perception into a numerical form, will be used to assess postoperative pain. NRS has a numerical scale ranging from 0 to 10. The patient will rate the intensity of pain on a scale from 0, indicating no pain, to 10, representing the worst imaginable pain (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and >8=intolerable pain). The NRS score will be evaluated both at rest and during active movement situations (such as transitioning from a lying to a sitting position).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 28913500Mauricio Del Rio J, Nicoara A, Swaminathan M. Neuroendocrine stress response: implications for cardiac surgery-associated acute kidney injury. Rom J Anaesth Intensive Care. 2017 Apr;24(1):57-63. doi: 10.21454/rjaic.7518.241.hav.
- Background: PubMed 27761032Chakraborty A, Khemka R, Datta T. Ultrasound-guided truncal blocks: A new frontier in regional anaesthesia. Indian J Anaesth. 2016 Oct;60(10):703-711. doi: 10.4103/0019-5049.191665.
- Background: PubMed 39259032Gungor H, Ciftci B, Koruk I, Ince A, Yanaral T, Tulgar S. A novel and promising regional anesthesia technique in living-donor renal transplantation surgery: quadro-iliac plane block. Pain Med. 2024 Dec 1;25(12):797-798. doi: 10.1093/pm/pnae090. No abstract available.
- Background: PubMed 39665467Ciftci B, Tulgar S, Sakul BU, Alver S, Alici HA. Inspiring Use of Novel Blocks in Chronic Pain Management: Quadro-iliac Plane Block a Promising Step Toward the Future-A Case Report. A A Pract. 2024 Dec 12;18(12):e01886. doi: 10.1213/XAA.0000000000001886. eCollection 2024 Dec 1.
- Background: PubMed 39258831Turan EI, Aslan C, Berber K, Sarban O, Sahin AS. Efficacy of quadro-iliac plane block in single level lumbar discectomies: a case series for novel block. Minerva Anestesiol. 2024 Dec;90(12):1159-1160. doi: 10.23736/S0375-9393.24.18314-9. Epub 2024 Sep 11. No abstract available.
- Background: PubMed 40160919Turan EI, Sahin AS. Quadro-iliac plane block (QIPB) in lumbar stabilisation surgeries: A case series. Indian J Anaesth. 2025 Feb;69(2):244-245. doi: 10.4103/ija.ija_1077_24. Epub 2025 Jan 29. No abstract available.
- Background: PubMed 39495169Turan EI, Baydemir AE, Sahin AS. Efficacy of the quadro-iliac plane block in postoperative pain management for proximal femoral nail surgeries. Minerva Anestesiol. 2025 Mar;91(3):221-223. doi: 10.23736/S0375-9393.24.18506-9. Epub 2024 Nov 4. No abstract available.
- Background: PubMed 38459608Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Girit M, Akin T, Narayanan M, Alici HA. Ultrasound guided quadro-iliac plane block: another novel fascial plane block. Pain Med. 2024 May 3;25(6):370-373. doi: 10.1093/pm/pnae018.
- Background: PubMed 21177284Aveline C, Le Hetet H, Le Roux A, Vautier P, Cognet F, Vinet E, Tison C, Bonnet F. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J Anaesth. 2011 Mar;106(3):380-6. doi: 10.1093/bja/aeq363. Epub 2010 Dec 21.
- Background: PubMed 34537121Okur O, Karaduman D, Tekgul ZT, Koroglu N, Yildirim M. Posterior quadratus lumborum versus transversus abdominis plane block for inguinal hernia repair: a prospective randomized controlled study. Braz J Anesthesiol. 2021 Sep-Oct;71(5):505-510. doi: 10.1016/j.bjane.2020.11.004. Epub 2021 Feb 10.
- Background: PubMed 16418039O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.
- Background: PubMed 19335342Suresh S, Chan VW. Ultrasound guided transversus abdominis plane block in infants, children and adolescents: a simple procedural guidance for their performance. Paediatr Anaesth. 2009 Apr;19(4):296-9. doi: 10.1111/j.1460-9592.2009.02958.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MEHMET YALVAÇ, MD principal investigator
Hitit University Faculty of Medicine
Zeynep Kaya, MD principal investigator
Hitit University Faculty of Medicine
Serhat Özçiftçi, MD principal investigator
Hitit University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abmoninis Plane Block and Quadro-Iliac Plane Block in people with Postoperative Pain, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Examination with Numeric Rating Scale (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07527065, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.