AzTrials
AzTrials

Postoperative PainNCT07796828

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

A study testing Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1), Ultrasound-Guided Transversus Abdominis Plane Block and Bupivacaine 0.25% in people with Postoperative Pain and Midline Laparotomy, run by Sheikh Zayed Medical College at 1 site in Pakistan.

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 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1), Ultrasound-Guided Transversus Abdominis Plane Block and Bupivacaine 0.25%
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePakistan
Study dates
Sep 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who cannot join

  • 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

Trial locations and contacts

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

Kiran Azhar, MBBS contact

03216220839

azharkiran136@gmail.com

Pakistan1 site
  • Sheikh Zayed Medical College/Hospital

    Rahim Yar Khan, Punjab Province

    Kiran Azhar, 03216220839, azharkiran136@gmail.com

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

Other trials in Pakistan

About this study

Official title: Analgesic Outcomes of Ultrasound Guided Quadratus Lumborum Block Compared With Transversus Abdominis Plane Block in Patients Undergoing Midline Laparotomy

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.

Read the detailed description

Midline laparotomy is associated with significant postoperative pain that can limit mobilization, impair respiratory function, and increase opioid-related side effects. Abdominal wall blocks such as the transversus abdominis plane (TAP) block and quadratus lumborum block (QLB) are used as part of multimodal analgesia. TAP primarily targets somatic afferents of the anterior abdominal wall, while QLB may provide broader coverage including potential paravertebral spread via the thoracolumbar fascia, potentially offering longer-lasting analgesia.

This single-center, prospective, randomized controlled trial will enroll 100 adults (50 per group) aged 18-65 years, ASA physical status I-III, scheduled for elective midline laparotomy under general anesthesia. Participants will be randomized 1:1 using sequentially numbered, opaque, sealed envelopes prepared by an independent research assistant. Both blocks will be performed after induction of general anesthesia and before surgical incision by an experienced anesthesiologist under ultrasound guidance and strict aseptic precautions.

Group A (QLB): Bilateral lateral quadratus lumborum (QL1) block with 20 mL of 0.25% bupivacaine per side (total 40 mL / 100 mg, not exceeding 2 mg/kg).

Group B (TAP): Bilateral TAP block with 20 mL of 0.25% bupivacaine per side (total 40 mL / 100 mg, not exceeding 2 mg/kg).

Postoperative analgesia will be standardized with intravenous paracetamol 1 g every 6 hours. Pain will be assessed using the Numerical Rating Scale (NRS 0-10) at 6, 12, and 24 hours by an independent, blinded outcome assessor. Rescue analgesia (intravenous morphine or tramadol) will be given for NRS ≥4. Primary and secondary analgesic outcomes include NRS scores, time to first rescue analgesia, proportion requiring rescue analgesia within 24 hours, and total opioid consumption in the first 24 hours. Block-related complications will also be recorded.

Statistical analysis will use SPSS version 26. Normality will be assessed by Shapiro-Wilk test. Continuous variables will be compared with independent-samples t-test or Mann-Whitney U test; categorical variables with Chi-square or Fisher's exact test. Potential confounders will be addressed by stratification. A two-sided p-value ≤0.05 will be considered statistically significant.

Being tested
Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1), Ultrasound-Guided Transversus Abdominis Plane Block, Bupivacaine 0.25%
Keywords
Quadratus Lumborum Block, Transversus Abdominis Plane Block, Ultrasound-Guided Regional Anesthesia, Postoperative Analgesia, Midline Laparotomy, Multimodal Analgesia
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1)Procedure or surgery

    Also called QLB, QL1 Block

    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.

  • Ultrasound-Guided Transversus Abdominis Plane BlockProcedure or surgery

    Also called TAP Block, TAPB

    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.

  • 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.

Study groups in NCT07796828
Study groupRoleWhat they receive
Group A: Quadratus Lumborum Block (QLB)ExperimentalParticipants 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).
Receives: Procedure: Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1); Drug: Bupivacaine 0.25%
Group B: Transversus Abdominis Plane Block (TAPB)Active comparatorParticipants 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).
Receives: Procedure: Ultrasound-Guided Transversus Abdominis Plane Block; Drug: Bupivacaine 0.25%

What is being measured

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

  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.

    Measured: 12 hours after completion of surgery

Secondary outcomes (6)
  1. Postoperative pain intensity at 6 hours

    Pain intensity measured using the Numerical Rating Scale (NRS 0-10) by an independent blinded outcome assessor.

    Measured: 6 hours after completion of surgery

  2. Postoperative pain intensity at 24 hours

    Pain intensity measured using the Numerical Rating Scale (NRS 0-10) by an independent blinded outcome assessor.

    Measured: 24 hours after completion of surgery

  3. Time to first rescue analgesia

    Time (in minutes or hours) from completion of surgery to the first administration of rescue analgesia for NRS score ≥4.

    Measured: From completion of surgery up to 24 hours postoperatively

  4. Proportion of participants requiring rescue analgesia within 24 hours

    Percentage of participants who receive at least one dose of rescue analgesia (for NRS ≥4) within the first 24 postoperative hours.

    Measured: First 24 hours after surgery

  5. Total opioid/rescue analgesic consumption within 24 hours

    Cumulative dose of opioid or rescue analgesic administered within the first 24 postoperative hours, recorded from the medication administration record.

    Measured: First 24 hours after surgery

  6. Incidence of block-related complications

    Any complication considered related to QLB or TAP block (e.g., local anesthetic systemic toxicity, hematoma, infection, nerve injury, block failure).

    Measured: During block performance and within 24 hours after the block

Timeline

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

  1. First posted1 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 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
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07796828
Sponsor's protocol ID
148/IRB/S.ZMC/SZH
Other IDs
148/IRB/SZMC/SZH
Status last verified
Aug 2026
First submitted
27 Aug 2026
Last updated
1 Sep 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 shared.

Publications

  • 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.

    PubMed 30662134
  • 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.

    PubMed 37867884

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1), Ultrasound-Guided Transversus Abdominis Plane Block and Bupivacaine 0.25% in people with Postoperative Pain and Midline Laparotomy, run by Sheikh Zayed Medical College at 1 site in Pakistan.

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 6 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: opening soon, as of the sponsor's last update on 1 Sep 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 Pakistan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kiran Azhar, MBBS (03216220839, azharkiran136@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain intensity at 12 hours (time frame: 12 hours after completion of surgery). 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 NCT07796828, which also lists 2 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 1 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in