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Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block in Laparoscopic Upper Abdominal Surgeries

Safety and Efficacy of Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block on Quality of Recovery in Laparoscopic Upper Abdominal Surgeries: A Randomized Comparative Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07720817
Enrollment
164
Registered
2026-07-22
Start date
2026-07-01
Completion date
2027-02-01
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Abdominal Surgeries, Retrolaminar Block, TAP Block

Brief summary

This study aims to compare and evaluate the safety and efficacy of ultrasound guided retrolaminar block versus transverse abdominis plane block in laparoscopic upper abdominal surgeries. Both RLB and TAP blockade are hypothesized to reduce analgesic consumption, manage pain effectively and minimize side effects but their comparative effectiveness has not yet to be thoroughly explored.

Detailed description

Laparoscopic surgery is now a widely accepted practice, offering several advantages, including better cosmetic outcomes, increased patient satisfaction, and shorter hospital stays . The complexity and range of procedures performed laparoscopically have grown significantly, now including complex operations like cholecystectomy, nephrectomy, hernia repair, and an increasing number of emergency surgeries . Despite these benefits, postoperative pain following laparoscopic procedures, such as cholecystectomy, can be substantial and hinder recovery . This pain may negatively affect respiratory function, delay ambulation, and ultimately prolong their hospital stay. Historically, pain management has often relied on high doses of narcotics, which may lead to complications like dizziness, respiratory depression, and postoperative nausea and vomiting (PONV) . These drawbacks have spurred the search for alternative and improved pain relief strategies . Ultrasound-guided nerve blocks have become an essential component of multimodal postoperative analgesia due to their effectiveness, precision, and safety profile . One of such techniques is the Transversus Abdominis Plane (TAP) block, which is used as part of a comprehensive strategy to optimize postoperative pain control. Local anesthetic is injected into the neurovascular plane of the abdominal wall . The TAP block works by providing sensory blockade to the spinal nerves that run between the internal oblique and transverse abdominis muscles. The anesthetic infiltration affects the thoracic intercostal nerves, the ilioinguinal and iliohypogastric nerves, and the lateral cutaneous branches of the lumbar nerves. Another important technique is the Retrolaminar Block (RLB), introduced in 2006 as a simpler alternative to the thoracic paravertebral block (TPVB) . The RLB is less invasive because it targets the bony vertebral lamina, unlike the TPVB, which requires puncturing the superior costotransverse ligament . The procedure involves injecting a local anesthetic (LA) into the fascial plane located between the posterior thoracic lamina and the overlying transversus spinae muscles allowing spread of the local anesthetic to the thoracic paravertebral and epidural spaces, thus the blockade of the dorsal branch of the spinal nerves that cross the retrolaminar plane .Studies, including cadaveric models, have confirmed that the anesthetic injected during an RLB spreads through the intertransverse ligaments into the paravertebral and epidural spaces, effectively numbing 2-4 spinal segments . For instance, a 2022 clinical trial showed that ultrasound-guided RLBs significantly reduced opioid consumption in patients recovering from laparoscopic cholecystectomy compared to conventional pain management , highlighting its potential as a safe and effective option.

Interventions

PROCEDUREUltrasound-guided Retrolaminar Block group

Ultrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic.

PROCEDURETransverses Abdominis Plane (TAP) Block Group

Ultrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age between 21 and 65 years. * American Society of Anesthesiologists (ASA) physical status I or II. * Body mass index (BMI) less than 30 kg/m². * Scheduled for elective laparoscopic upper abdominal surgery under general anesthesia.

Exclusion criteria

* Refusal to participate in the study. * Known allergy or hypersensitivity to any of the study drugs. * Infection at the planned block insertion site. * Severe uncontrolled cardiac, renal, hepatic, neurological, or respiratory disease. * Pre-existing chronic pain. * Immunodeficiency. * Coagulation abnormalities, anticoagulant therapy, or platelet count less than 80,000/µL. * Emergency surgery.

Design outcomes

Primary

MeasureTime frameDescription
The postoperative Quality of Recovery-15 score24 hour postoperativeThe Quality of Recovery-15 (QoR-15) questionnaire consists of 15 items. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.

Secondary

MeasureTime frameDescription
Numeric Rating Scale (NRS) at rest and during coughingImmediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.Postoperative pain intensity at rest and during coughing will be assessed using the Numeric Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain . Higher scores indicate greater pain intensity (worse outcome).
Total dose of rescue analgesics administered (mg) within the first 24 hours after surgeryFrom the end of surgery to 24 hours after surgery.The cumulative dose of rescue postoperative analgesics administered to each participant during the first 24 hours after surgery will be recorded. Higher values indicate greater postoperative analgesic requirements.
Time to first postoperative opioid analgesic request (hours)From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperativelyTime from the end of surgery until the first postoperative request for opioid analgesia
Duration of hospital stayFrom the date of surgery until hospital discharge, assessed for up to 30 days after surgeryDuration of hospital stay, measured as the number of days from the date of surgery until hospital discharge.
Mean intraoperative mean arterial pressure (mmHg)At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), will be recorded during surgery
Mean intraoperative heart rate (beats/min)At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.Heart rate (HR), measured in beats per minute (beats/min), will be recorded during surgery
Mean intraoperative peripheral oxygen saturation (%)At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.Peripheral oxygen saturation (SpO₂), measured as percentage (%), will be recorded during surgery
Number of participants with postoperative nauseaFrom the end of surgery to 24 hours after surgeryNumber of participants who experienced postoperative nausea
Number of participants with postoperative vomitingFrom the end of surgery to 24 hours after surgeryNumber of participants who experienced postoperative vomiting
Number of participants with postoperative shiveringFrom the end of surgery to 24 hours after surgeryNumber of participants who experienced postoperative shivering
Number of participants with postoperative hypotensionFrom the end of surgery to 24 hours after surgeryNumber of participants who experienced postoperative hypotension
Number of participants with postoperative bradycardiaFrom the end of surgery to 24 hours after surgeryNumber of participants who experienced postoperative bradycardia
Number of participants with postoperative headacheFrom the end of surgery to 24 hours after surgeryNumber of participants who experienced postoperative headache
Total intraoperative ephedrine dose administered (mg)From induction of anesthesia until the end of surgeryThe cumulative dose of ephedrine administered intraoperatively for the treatment of hypotension, measured in milligrams (mg).
Number of participants requiring intraoperative ephedrine administrationFrom induction of anesthesia until the end of surgeryNumber of participants who required ephedrine administration for the treatment of intraoperative hypotension.

Countries

Egypt

Contacts

CONTACTmohamed elnagar Mohamed A. Elnagar MB BCh, MB BCh
melnaggar789@gmail.com+20 1009344804
STUDY_CHAIRhatem saber mohamed ali, Professor

Faculty of Medicine, Mansoura University

STUDY_CHAIRNaglaa A Elnegeery, Associate Professor

Faculty of Medicine, Mansoura University

STUDY_DIRECTOROla Shawky Naguib El Nagar, Lecturer

Faculty of Medicine, Mansoura University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026