Analgesic Outcomes of Ultrasound-Guided QLB vs TAP Block in Midline Laparotomy

NCT07796828 | Not Yet Recruiting

• 2 other identifiers: 148/IRB/S.ZMC/SZH148/IRB/SZMC/SZH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial compares the analgesic efficacy of ultrasound-guided bilateral lateral quadratus lumborum block (QLB, QL1) versus ultrasound-guided bilateral transversus abdominis plane (TAP) block in adults undergoing elective midline laparotomy under general anesthesia. The primary focus is postoperative pain intensity, time to first rescue analgesia, proportion requiring rescue analgesia, and total opioid consumption in the first 24 hours.

Conditions

Postoperative Pain; Midline Laparotomy; Abdominal Surgery

Keywords

Quadratus Lumborum Block; Transversus Abdominis Plane Block; Ultrasound-Guided Regional Anesthesia; Postoperative Analgesia; Midline Laparotomy; Multimodal Analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity at 12 hours

  Pain intensity measured using the Numerical Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) assessed by an independent blinded outcome assessor.

  12 hours after completion of surgery

Secondary Outcomes (6)

• Postoperative pain intensity at 6 hours

  6 hours after completion of surgery

• Postoperative pain intensity at 24 hours

  24 hours after completion of surgery

• Time to first rescue analgesia

  From completion of surgery up to 24 hours postoperatively

• Proportion of participants requiring rescue analgesia within 24 hours

  First 24 hours after surgery

• Total opioid/rescue analgesic consumption within 24 hours

  First 24 hours after surgery

Study Arms (2)

Group A: Quadratus Lumborum Block (QLB)

EXPERIMENTAL

Participants receive bilateral ultrasound-guided lateral quadratus lumborum (QL1) block after induction of general anesthesia and before surgical incision. 20 mL of 0.25% bupivacaine is injected on each side (total 40 mL / 100 mg, dose not exceeding 2 mg/kg).

Procedure: Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1); Drug: Bupivacaine 0.25%

Group B: Transversus Abdominis Plane Block (TAPB)

ACTIVE COMPARATOR

Participants receive bilateral ultrasound-guided transversus abdominis plane block after induction of general anesthesia and before surgical incision. 20 mL of 0.25% bupivacaine is injected on each side (total 40 mL / 100 mg, dose not exceeding 2 mg/kg).

Procedure: Ultrasound-Guided Transversus Abdominis Plane Block; Drug: Bupivacaine 0.25%

Interventions

Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1) PROCEDURE

After induction of general anesthesia and before surgical incision, under strict aseptic precautions, a low-frequency curvilinear ultrasound transducer is placed between the costal margin and iliac crest. An echogenic 22-gauge 80-100 mm block needle is advanced in-plane toward the anterolateral border of the quadratus lumborum muscle near the junction of the transversus abdominis aponeurosis and transversalis fascia. After hydrodissection and negative aspiration, 20 mL of 0.25% bupivacaine is injected on each side under continuous ultrasound visualization of local anesthetic spread. Total planned volume 40 mL (100 mg bupivacaine), not exceeding 2 mg/kg.

Also known as: QLB, QL1 Block

Group A: Quadratus Lumborum Block (QLB)

Ultrasound-Guided Transversus Abdominis Plane Block PROCEDURE

After induction of general anesthesia and before surgical incision, under strict aseptic precautions, a high-frequency linear ultrasound transducer is placed transversely on the anterolateral abdominal wall between the costal margin and iliac crest. The external oblique, internal oblique, and transversus abdominis muscles are identified. An echogenic 22-gauge block needle is advanced in-plane until the tip lies in the fascial plane between the internal oblique and transversus abdominis muscles. After hydrodissection and negative aspiration, 20 mL of 0.25% bupivacaine is injected on each side under continuous ultrasound visualization of local anesthetic spread. Total planned volume 40 mL (100 mg bupivacaine), not exceeding 2 mg/kg.

Also known as: TAP Block, TAPB

Group B: Transversus Abdominis Plane Block (TAPB)

Bupivacaine 0.25% DRUG

Local anesthetic used for both QLB and TAP blocks: 20 mL of 0.25% bupivacaine per side (total 40 mL / 100 mg), dose adjusted not to exceed 2 mg/kg body weight.

Group A: Quadratus Lumborum Block (QLB); Group B: Transversus Abdominis Plane Block (TAPB)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Either sex
• Scheduled for elective midline laparotomy (upper, lower, or full midline incision) under general anesthesia
• ASA physical status I-III

You may not qualify if:

• Body mass index \>40 kg/m²
• Existing chronic pain disorder, established opioid dependence, or history of substance abuse
• Previous or current neurological or psychiatric illness likely to compromise comprehension, decision-making capacity, or reliable reporting of pain scores
• Conditions in which an abdominal wall block would not be appropriate or safe (bleeding tendency, ongoing anticoagulation outside acceptable limits, local skin or soft-tissue infection at the planned puncture site, or major distortion of abdominal wall anatomy)
• Urgent laparotomy performed for peritonitis or unstable physiology (including patients requiring continuous vasopressor support)
• Previous abdominal wall surgery, large incisional hernia, or distorted flank/anterior abdominal wall anatomy likely to impair standardized block placement

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh Zayed Medical College/Hospital

Rahim Yar Khan, Punjab Province, Pakistan

Location

Related Publications (2)

• Gnanasekar N, Kumar GD, Kurhekar P, Raghuraman MS, Prasad TK. Comparative Evaluation of Ropivacaine and Ropivacaine with Dexamethasone in Transverse Abdominis Plane Block for Lower Abdominal Surgeries: A Prospective, Randomized, Double-Blinded Study. Anesth Essays Res. 2018 Oct-Dec;12(4):937-942. doi: 10.4103/aer.AER_162_18.

  PMID: 30662134 BACKGROUND

• Dai J, Lin S, Cui X, Xu Z, Zheng R, Wu D. The effects of ultrasound-guided QLB and TAPB combined with opioid-free anesthesia (OFA) on clinical efficacy of the patients undergoing abdominal surgery. Heliyon. 2023 Oct 11;9(10):e20878. doi: 10.1016/j.heliyon.2023.e20878. eCollection 2023 Oct.

  PMID: 37867884 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kiran Azhar, MBBS, FCPS-II (Anesthesia) PGR

  Department of Anesthesiology & ICU, Sheikh Zayed Medical College/Hospital, Rahim Yar Khan

  PRINCIPAL INVESTIGATOR

• Sairah Sadaf, FCPS

  Department of Anesthesiology & ICU, Sheikh Zayed Medical College/Hospital, Rahim Yar Khan

  STUDY CHAIR

Central Study Contacts

Kiran Azhar, MBBS

CONTACT

03216220839; azharkiran136@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will remain blinded to group allocation because both blocks are performed after induction of general anesthesia. The anesthesiologist administering the block cannot be blinded. Postoperative pain assessment and outcome recording will be performed by an independent outcome assessor who remains blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate Resident (FCPS-II Anesthesia)

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)