Inguinal Hernia UnilateralQIPB-LIHRNCT07878936
Quadro-Iliac Plane Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Repair
A study testing Quadro-iliac plane block in people with Inguinal Hernia Unilateral and Postoperative Pain, run by Marmara University Pendik Training and Research Hospital.
Trial summary
The goal of this randomized controlled trial is to learn whether an ultrasound-guided quadro-iliac plane block (QIPB) reduces opioid use and pain after laparoscopic inguinal hernia repair in adults aged 18-65 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inguinal Hernia Unilateral, Postoperative Pain, Opioid Use
- What is being tested?
- Quadro-iliac plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Oct 2027
- Phase
- Interventional
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
- Age 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective unilateral laparoscopic inguinal hernia repair (TAPP or TEP) under general anesthesia
- Written informed consent
Who cannot join
- Refusal to participate
- Bilateral hernia repair or conversion to open surgery
- Known allergy to local anesthetics or study drugs
- Coagulopathy or ongoing therapeutic anticoagulation
- Infection at the block site
- Chronic pain or regular opioid use before surgery
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- Severe hepatic or renal dysfunction
- Pregnancy
- Inability to understand the NRS or use the PCA device
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Postoperative Opioid Requirement and Pain Scores in Patients With and Without Quadro-Iliac Plane Block Undergoing Laparoscopic Inguinal Hernia Repair: A Prospective Randomized Controlled Trial
The goal of this randomized controlled trial is to learn whether an ultrasound-guided quadro-iliac plane block (QIPB) reduces opioid use and pain after laparoscopic inguinal hernia repair in adults aged 18-65 years. The main question it aims to answer is: does QIPB reduce total tramadol consumption during the first 24 postoperative hours? Researchers will compare patients who receive QIPB under general anesthesia with patients who receive no block. All participants will receive the same general anesthesia, multimodal analgesia and intravenous tramadol patient-controlled analgesia (PCA). Pain scores, PCA use, quality of recovery (QoR-15), nausea and vomiting, and time to discharge will be recorded during the first 24 hours.
Read the detailed description
Laparoscopic inguinal hernia repair (TAPP or TEP) causes less pain than open repair, but many patients still report moderate to severe pain in the early postoperative period, with both somatic and visceral components. The quadro-iliac plane block is a recently described fascial plane block in which local anesthetic is injected between the inner surface of the iliac crest and the posterior surface of the quadratus lumborum muscle. Cadaveric data show spread to the ilioinguinal, iliohypogastric, subcostal and genitofemoral nerves and the lumbar plexus, and case series suggest effective analgesia after inguinal hernia surgery.
This single-center, prospective, randomized, controlled, outcome-assessor-blinded trial will be conducted at Marmara University Pendik Training and Research Hospital. Sixty-four patients will be randomized 1:1 by computer-generated random numbers to Group QIPB or Group C (control). The anesthesia team will know the group allocation; the investigator assessing outcomes will be blinded.
All patients will receive standard monitoring (ECG, non-invasive blood pressure, SpO2, EtCO2, bispectral index) and IV midazolam 0.02 mg/kg premedication. Anesthesia will be induced with remifentanil 2 µg/kg, propofol 2-2.5 mg/kg and rocuronium 0.6 mg/kg, and maintained with desflurane and remifentanil infusion, targeting BIS 40-60. In Group QIPB, after induction and in the lateral position, a unilateral QIPB will be performed on the surgical side with a low-frequency convex probe placed parasagittally at the attachment of the quadratus lumborum to the iliac crest. Using an in-plane approach with a 100-mm block needle, needle position will be confirmed with 5 mL saline, followed by 40 mL of 0.25% bupivacaine with intermittent aspiration. Group C will receive no block.
Fifteen minutes before the end of surgery, all patients will receive IV paracetamol 1 g, tramadol 1.5 mg/kg and ondansetron 8 mg. After surgery, all patients will receive IV tramadol PCA (10 mg/mL; 1 mL bolus; 10-minute lockout). Patients with NRS > 4 will receive rescue IV morphine 4 mg. Pain scores at rest and on coughing and cumulative tramadol consumption will be recorded at 0, 6, 12 and 24 hours. The QoR-15 questionnaire will be administered preoperatively (baseline) and at 24 hours.
The sample size was calculated using G*Power 3.1. Assuming a mean 24-hour tramadol consumption of 85 mg in the control group, a minimum clinically relevant reduction of 25 mg (approx. 30%) and an SD of 30 mg (Cohen's d = 0.83), with α = 0.05 and power = 0.80, 24 patients per group are required. To allow for dropouts and protocol violations, 32 patients per group (64 in total) will be enrolled. Data will be analyzed using the independent-samples t-test or Mann-Whitney U test, repeated-measures ANOVA or linear mixed-effects models for pain scores over time, Kaplan-Meier analysis with the log-rank test for time to first PCA demand, chi-square or Fisher's exact test for categorical outcomes, and ANCOVA adjusted for baseline QoR-15. A two-sided p < 0.05 will be considered statistically significant.
- Conditions
- Inguinal Hernia Unilateral, Postoperative Pain, Opioid Use
- Being tested
- Quadro-iliac plane block
- Keywords
- quadro-iliac plane block, fascial plane block, regional anesthesia, laparoscopic inguinal hernia repair, TAPP, TEPP, patient-controlled analgesia, tramadol, quality of recovery, QoR-15
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadro-iliac plane blockProcedure or surgery
With the patient in the lateral position, a low-frequency convex probe is placed parasagittally at the attachment of the quadratus lumborum to the iliac crest. Using an in-plane approach with a 100-mm block needle, position is confirmed with 5 mL saline, followed by 40 mL of 0.25% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Group QIPB | Experimental | Unilateral ultrasound-guided quadro-iliac plane block on the surgical side after induction of general anesthesia (40 mL 0.25% bupivacaine), plus standard multimodal analgesia and IV tramadol PCA. Receives: Procedure: Quadro-iliac plane block |
| Group C (Control) | No intervention | No block. Standard general anesthesia, multimodal analgesia and IV tramadol PCA only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total tramadol consumption
Cumulative tramadol (mg) delivered by the IV PCA device during the first 24 postoperative hours
Measured: 0-24 hours after surgery
Secondary outcomes (6)
Pain score at rest
Numeric Rating Scale (NRS), 0 = no pain, 10 = worst imaginable pain
Measured: 0, 6, 12 and 24 hours after surgery
Pain score on coughing
NRS (0-10) during coughing
Measured: 0, 6, 12 and 24 hours after surgery
Time to first PCA demand
Time (minutes) from arrival in the PACU to the first patient-activated PCA bolus
Measured: Up to 24 hours after surgery
Quality of recovery
QoR-15 total score (0-150; higher = better recovery), adjusted for preoperative baseline QoR-15
Measured: Preoperatively (baseline) and 24 hours after surgery
Postoperative nausea and vomiting
Incidence and severity (0 = none, 1 = mild nausea, 2 = severe nausea, 3 = vomiting); need for additional antiemetics
Measured: 0, 6, 12 and 24 hours after surgery
Intraoperative remifentanil consumption
Total remifentanil dose (µg) during anesthesia
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia UnilateralStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dilara gocmen, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878936
- Sponsor's protocol ID
- MU-ANES-QIPB-2026
- Acronym
- QIPB-LIHR
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tulgar 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 38459608Sorrentino T, Pullano C, Marrone F. A novel and feasible option for postoperative analgesia in hernia repair surgery: quadro-iliac plane block. Minerva Anestesiol. 2025 Sep;91(9):857-858. doi: 10.23736/S0375-9393.25.19017-2. Epub 2025 May 7. No abstract available.
PubMed 40332067Satici MH, Altay N. Quadro-iliac plane block in inguinal hernia surgery. Minerva Anestesiol. 2025 May;91(5):475-476. doi: 10.23736/S0375-9393.25.18739-7. Epub 2025 Feb 18. No abstract available.
PubMed 39964109Tolver MA, Strandfelt P, Rosenberg J, Bisgaard T. Pain characteristics after laparoscopic inguinal hernia repair. Surg Endosc. 2011 Dec;25(12):3859-64. doi: 10.1007/s00464-011-1810-2. Epub 2011 Jun 18.
PubMed 21688078Hubbard G, Hubert C, Vudayagiri L, Tullington J, Merino K, Vaidya A, Gemma R. Transversus abdominis plane blocks in laparoscopic inguinal hernia repair: a review. Hernia. 2023 Oct;27(5):1059-1065. doi: 10.1007/s10029-023-02831-x. Epub 2023 Jul 3.
PubMed 37395916