NCT07527065

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
0mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2025May 2026

Study Start

First participant enrolled

September 29, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Expected
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 8, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

open inguinal hernia repairpostoperative paintransversus abdominis plane blockquadro-iliac plane block

Outcome Measures

Primary Outcomes (1)

  • 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).

    24 hours

Study Arms (2)

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.

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.

Procedure: Quadro-Iliac Plane Block

Interventions

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.

Group T (Transversus Abmoninis 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.

Group Q ( Quadro-Iliac Plane Block)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University Erol Olcok Training and Research Hospital,

Çorum, Merkez, 19200, Turkey (Türkiye)

Location

Related Publications (17)

  • 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.

    PMID: 28913500BACKGROUND
  • Chakraborty 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.

    PMID: 27761032BACKGROUND
  • Gungor 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 Aug 26:pnae090. doi: 10.1093/pm/pnae090. Online ahead of print. No abstract available.

    PMID: 39259032BACKGROUND
  • Ciftci 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.

    PMID: 39665467BACKGROUND
  • Turan 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.

    PMID: 39258831BACKGROUND
  • Turan 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.

    PMID: 40160919BACKGROUND
  • Turan 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.

    PMID: 39495169BACKGROUND
  • 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.

    PMID: 38459608BACKGROUND
  • Aveline 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.

    PMID: 21177284BACKGROUND
  • Okur 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.

    PMID: 34537121BACKGROUND
  • O'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. Erratum In: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added].

    PMID: 16418039BACKGROUND
  • Suresh 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.

    PMID: 19335342BACKGROUND
  • McDonnell 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.

    PMID: 17179269BACKGROUND
  • Oksuz 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.

    PMID: 28759502BACKGROUND
  • Cevikkalp 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.

    PMID: 29332115BACKGROUND
  • Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.

    PMID: 26509324BACKGROUND
  • Lv J, Zhang Q, Zeng T, Li XF, Cui Y. Regional block anesthesia for adult patients with inguinal hernia repair: A systematic review. Medicine (Baltimore). 2022 Sep 23;101(38):e30654. doi: 10.1097/MD.0000000000030654.

    PMID: 36197234BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • MEHMET YALVAÇ, MD

    Hitit University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Zeynep Kaya, MD

    Hitit University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Serhat Özçiftçi, MD

    Hitit University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

April 8, 2026

First Posted

April 14, 2026

Study Start

September 29, 2025

Primary Completion

February 10, 2026

Study Completion (Estimated)

May 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations