AzTrials
AzTrials

Inguinal Hernia UnilateralNCT07864064

Comparison of Quadro-Iliac Plane Block and Transversalis Fascia Plane Block for Open Inguinal Hernia Repair

An observational study of Inguinal Hernia Unilateral, run by Vezirköprü State Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

Search all trials

Trial summary

This prospective observational cohort study aims to compare the postoperative analgesic effectiveness of the quadro-iliac plane block (QIPB) and transversalis fascia plane block (TFPB) in patients undergoing elective unilateral open inguinal hernia repair under spinal anesthesia. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Inguinal Hernia Unilateral
What is being tested?
Quadro iliac Plane Block and Transversalis Fascia Plane Block
Type of treatment
Surgery or procedure
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Oct 2026to 28 Feb 2027
How long will I take part?
1 Day
Phase
Observational

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients aged 18-75 years with ASA physical status I-II who are scheduled for elective unilateral open inguinal hernia repair under spinal anesthesia at Vezirköprü State Hospital and receive either QIPB or TFPB as part of routine clinical practice will be prospectively enrolled. The choice of block technique will be determined by the attending anesthesiologist independently of study participation.

Who may be able to join

  • Age between 18 and 75 years.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Scheduled for elective unilateral open inguinal hernia repair.
  • Eligible to undergo spinal anesthesia.
  • Provision of written informed consent to participate in the study.

Who cannot join

  • Refusal to participate in the study.
  • Contraindication to spinal anesthesia or peripheral nerve/interfascial plane block.
  • Coagulopathy or clinically significant bleeding disorder.
  • Infection at the block injection site.
  • Known allergy to local anesthetics or any medication used in the study.
  • Chronic opioid use or regular use of analgesic or anticonvulsant medications that may affect pain perception.
  • Communication or cognitive impairment that prevents reliable NRS assessment.
  • Inadequate or failed spinal anesthesia or requirement for conversion to general anesthesia.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Betül Yılmaz, MD contact

+90 505 035 64 70

betuluslucan@gmail.com

Turkey (Türkiye)1 site
  • Vezirköprü state hospital

    Samsun, Samsun

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Postoperative Analgesic Effectiveness of Quadro-Iliac Plane Block and Transversalis Fascia Plane Block in Open Inguinal Hernia Repair Under Spinal Anesthesia: A Prospective Observational Cohort Study

This prospective observational cohort study aims to compare the postoperative analgesic effectiveness of the quadro-iliac plane block (QIPB) and transversalis fascia plane block (TFPB) in patients undergoing elective unilateral open inguinal hernia repair under spinal anesthesia. The choice of block technique will be determined by the attending anesthesiologist as part of routine clinical practice, independently of study participation, and no randomization or study-directed assignment will be performed. Patients receiving QIPB or TFPB will be prospectively followed as two cohorts. Postoperative pain scores at rest and during coughing will be assessed at 2, 4, 6, 12, and 24 hours. Time to first rescue analgesic requirement, rescue tramadol use, block performance time, and adverse events will also be compared between the two cohorts.

Read the detailed description

Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide. Open inguinal hernia repair may be associated with moderate to severe postoperative pain, and inadequate acute pain control may adversely affect recovery and contribute to the development of chronic pain. The PROSPECT recommendations support the use of local and/or regional analgesic techniques as part of multimodal analgesia for open inguinal hernia repair. The sensory innervation of the inguinal region involves the subcostal, iliohypogastric, ilioinguinal, and genitofemoral nerves.

The transversalis fascia plane block (TFPB), described by Hebbard, is an interfascial plane block in which local anesthetic is injected into the plane between the transversus abdominis muscle and the transversalis fascia, targeting the T12-L1 region. The analgesic efficacy of TFPB for open inguinal hernia repair has been evaluated in randomized controlled studies.

The quadro-iliac plane block (QIPB) is a recently described interfascial plane block introduced by Tulgar et al. in 2024. In a cadaveric study, injectate spread to the ilioinguinal, iliohypogastric, subcostal, and genitofemoral nerves was reported. To our knowledge, no study has directly compared QIPB and TFPB for postoperative analgesia in patients undergoing open inguinal hernia repair.

This is a prospective observational cohort study to be conducted at Vezirköprü State Hospital between October 30, 2026, and February 28, 2027. The decision to perform QIPB or TFPB in patients included in the study will not be made according to the research protocol, and no randomization will be performed. The block technique to be applied will be determined independently of the patient's inclusion in the study, according to the routine clinical practice and clinical judgment of the attending anesthesiologist responsible for the patient. The investigators will not provide any guidance regarding the selection of the block technique. Patients receiving QIPB or TFPB as part of routine clinical practice will be prospectively followed and evaluated as two cohorts.

Following standard monitoring (electrocardiography, noninvasive blood pressure, and pulse oximetry), patients will be placed in the sitting position, and spinal anesthesia will be performed under aseptic conditions using a 25-G Quincke spinal needle via a midline approach at the L3-L4 or L4-L5 intervertebral space. After confirmation of free cerebrospinal fluid (CSF) flow, 13 mg of 0.5% hyperbaric bupivacaine and 15 μg of fentanyl will be administered intrathecally. For postoperative analgesia, 1 g of intravenous paracetamol and 50 mg of intravenous dexketoprofen will be administered.

At the end of surgery, block procedures will be performed under aseptic conditions and ultrasound guidance (Mindray) by anesthesiologists experienced in the respective block technique. For QIPB, the patient will be placed in the lateral decubitus position, and a convex ultrasound probe will be used to identify the quadratus lumborum muscle at its attachment to the iliac crest. The local anesthetic will be injected into the quadro-iliac plane between the posterior surface of the quadratus lumborum muscle and the inner surface of the iliac crest. TFPB will be performed with the patient in the supine position using a linear ultrasound probe, with the injection administered immediately beneath the fascia of the transversus abdominis muscle. An 80-mm Braun block needle will be used for both block procedures. As part of routine clinical practice, 40 mL of 0.25% bupivacaine will be used in patients receiving QIPB, whereas 30 mL of 0.25% bupivacaine will be used in patients receiving TFPB. Block performance time will be defined as the time from initial contact of the ultrasound probe with the patient until completion of the local anesthetic injection and will be recorded in seconds.

Postoperative analgesia will be continued in a standardized manner according to the institution's routine clinical practice. All patients will receive 1 g of intravenous paracetamol every 8 hours and 50 mg of intravenous dexketoprofen every 12 hours. When the NRS score is 4 or higher, intravenous tramadol at a dose of 1 mg/kg will be administered as rescue analgesia.

NRS scores will be recorded at rest and during coughing at 2, 4, 6, 12, and 24 hours postoperatively. The time to first rescue analgesic requirement, rescue tramadol use, block performance time, and adverse events including nausea, vomiting, hypotension, bradycardia, local anesthetic systemic toxicity, and other adverse events related to the block procedure will be monitored and recorded.

Being tested
Quadro iliac Plane Block, Transversalis Fascia Plane Block
Keywords
Quadro-Iliac Plane Block, Transversalis Fascia Plane Block, Regional Anesthesia, Postoperative Analgesia, Postoperative Pain, Spinal Anesthesia, Open Inguinal Hernia Repair
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

    Ultrasound-guided quadro-iliac plane block (QIPB) performed as part of routine clinical practice. In patients receiving QIPB, 40 mL of 0.25% bupivacaine is administered into the quadro-iliac plane.

  • Transversalis Fascia Plane BlockProcedure or surgery

    Ultrasound-guided transversalis fascia plane block (TFPB) performed as part of routine clinical practice. In patients receiving TFPB, 30 mL of 0.25% bupivacaine is administered into the transversalis fascia plane.

Study groups in NCT07864064
Study groupRoleWhat they receive
QIPBPatients undergoing elective unilateral open inguinal hernia repair under spinal anesthesia who receive a quadro-iliac plane block (QIPB) as part of routine clinical practice. The decision to perform QIPB is made by the attending anesthesiologist independently of study participation.
Receives: Procedure: Quadro iliac Plane Block
TFPBPatients undergoing elective unilateral open inguinal hernia repair under spinal anesthesia who receive a transversalis fascia plane block (TFPB) as part of routine clinical practice. The decision to perform TFPB is made by the attending anesthesiologist independently of study participation.
Receives: Procedure: Transversalis Fascia Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Intensity at Rest

    Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).

    Measured: At 2, 4, 6, 12, and 24 hours postoperatively

  2. Postoperative Pain Intensity During Coughing

    Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).

    Measured: At 2, 4, 6, 12, and 24 hours postoperatively

Secondary outcomes (3)
  1. Time to First Rescue Tramadol Requirement

    Time from the end of surgery to the first administration of intravenous rescue tramadol (1 mg/kg) for an NRS score of 4 or higher will be recorded in minutes.

    Measured: Within the first 24 hours postoperatively

  2. Block Performance Time

    Block performance time will be defined as the time from initial contact of the ultrasound probe with the patient until completion of the local anesthetic injection and will be recorded in seconds.

    Measured: Within the first 24 hours postoperatively

  3. Incidence of Adverse Events

    The incidence of nausea, vomiting, hypotension, bradycardia, local anesthetic systemic toxicity, and other adverse events related to the block procedure will be recorded.

    Measured: Within the first 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07864064
Sponsor's protocol ID
QIPB-TFPB-01
Status last verified
Oct 2026
First submitted
2 Oct 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly shared to protect participant confidentiality and privacy. Aggregate study results will be reported in scientific publications.

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 38459608
  • Priya V, Shamim R, Singh B, Singh S, Bais PS, Prasad G. Comparative evaluation of pre-emptive analgesic efficacy of Posterior Transversus Abdominis Plane block with Fascia Transversalis Plane Block in adult patients undergoing unilateral inguinal hernia repair: A prospective, randomized, single-blind, two-arm parallel study. Saudi J Anaesth. 2024 Apr-Jun;18(2):211-217. doi: 10.4103/sja.sja_893_23. Epub 2024 Mar 14.

    PubMed 38654861
  • Celik HK, Tulgar S, Buk OF, Koc K, Unal M, Genc C, Suren M. Comparison of the analgesic efficacy of the ultrasound-guided transversalis fascia plane block and erector spinae plane block in patients undergoing open inguinal hernia repair under spinal anesthesia. Korean J Anesthesiol. 2024 Apr;77(2):255-264. doi: 10.4097/kja.23404. Epub 2024 Jan 8.

    PubMed 38185619
  • Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.

    PubMed 19495909
  • Moseholm VB, Baker JJ, Rosenberg J. Nerve identification during open inguinal hernia repair: a systematic review and meta-analyses. Langenbecks Arch Surg. 2023 Oct 24;408(1):417. doi: 10.1007/s00423-023-03154-2.

    PubMed 37874414
  • Coppens S, Gidts J, Huynen P, Van de Velde M, Joshi GP, on behalf of the PROSPECT Working Group collaboration. Pain management after open inguinal hernia repair: an updated systematic review and procedure-specific postoperative pain management (PROSPECT/ESRA) recommendations. Acta Anaesthesiol Belg. 2020;71(Suppl 1):45-56

  • Reinpold W. Risk factors of chronic pain after inguinal hernia repair: a systematic review. Innov Surg Sci. 2017 May 12;2(2):61-68. doi: 10.1515/iss-2017-0017. eCollection 2017 Jun.

    PubMed 31579738
  • Stabilini C, van Veenendaal N, Aasvang E, Agresta F, Aufenacker T, Berrevoet F, Burgmans I, Chen D, de Beaux A, East B, Garcia-Alamino J, Henriksen N, Kockerling F, Kukleta J, Loos M, Lopez-Cano M, Lorenz R, Miserez M, Montgomery A, Morales-Conde S, Oppong C, Pawlak M, Podda M, Reinpold W, Sanders D, Sartori A, Tran HM, Verdaguer M, Wiessner R, Yeboah M, Zwaans W, Simons M. Update of the international HerniaSurge guidelines for groin hernia management. BJS Open. 2023 Sep 5;7(5):zrad080. doi: 10.1093/bjsopen/zrad080.

    PubMed 37862616

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in