Retrolaminar BlockNCT07720817
Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block in Laparoscopic Upper Abdominal Surgeries
A study testing Ultrasound-guided Retrolaminar Block group and Transverses Abdominis Plane (TAP) Block Group in people with Retrolaminar Block and TAP Block, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Retrolaminar Block, TAP Block, Laparoscopic Abdominal Surgeries
- What is being tested?
- Ultrasound-guided Retrolaminar Block group and Transverses Abdominis Plane (TAP) Block Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to Feb 2027
- Phase
- Interventional
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, Dakahlia Governorate
mohamed a Mohamed A. Elnagar MB BCh, MB BCh, +20 1009344804, melnaggar789@gmail.com
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Ultrasound-guided Retrolaminar Block group, Transverses Abdominis Plane (TAP) Block Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Retrolaminar Block groupProcedure or surgery
Ultrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic.
Transverses Abdominis Plane (TAP) Block GroupProcedure or surgery
Ultrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Retrolaminar Block Group | Experimental | Patients will receive an ultrasound-guided retrolaminar block using 20 ml of 0.25% of bupivacaine administered at the T7 level at both sides Receives: Procedure: Ultrasound-guided Retrolaminar Block group |
| Transverses Abdominis Plane (TAP) Block Group | Active comparator | Patients will receive an ultrasound-guided TAP block using 20 ml of 0.25% bupivacaine at both sids Receives: Procedure: Transverses Abdominis Plane (TAP) Block Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative Quality of Recovery-15 score
The 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.
Measured: 24 hour postoperative
Secondary outcomes (15)
Numeric Rating Scale (NRS) at rest and during coughing
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).
Measured: Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.
Total dose of rescue analgesics administered (mg) within the first 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.
Measured: From the end of surgery to 24 hours after surgery.
Time to first postoperative opioid analgesic request (hours)
Time from the end of surgery until the first postoperative request for opioid analgesia
Measured: From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
Duration of hospital stay
Duration of hospital stay, measured as the number of days from the date of surgery until hospital discharge.
Measured: From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
Mean intraoperative mean arterial pressure (mmHg)
Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), will be recorded during surgery
Measured: 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 intraoperative heart rate (beats/min)
Heart rate (HR), measured in beats per minute (beats/min), will be recorded during surgery
Measured: 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 intraoperative peripheral oxygen saturation (%)
Peripheral oxygen saturation (SpO₂), measured as percentage (%), will be recorded during surgery
Measured: 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.
Number of participants with postoperative nausea
Number of participants who experienced postoperative nausea
Measured: From the end of surgery to 24 hours after surgery
Number of participants with postoperative vomiting
Number of participants who experienced postoperative vomiting
Measured: From the end of surgery to 24 hours after surgery
Number of participants with postoperative shivering
Number of participants who experienced postoperative shivering
Measured: From the end of surgery to 24 hours after surgery
Number of participants with postoperative hypotension
Number of participants who experienced postoperative hypotension
Measured: From the end of surgery to 24 hours after surgery
Number of participants with postoperative bradycardia
Number of participants who experienced postoperative bradycardia
Measured: From the end of surgery to 24 hours after surgery
Number of participants with postoperative headache
Number of participants who experienced postoperative headache
Measured: From the end of surgery to 24 hours after surgery
Total intraoperative ephedrine dose administered (mg)
The cumulative dose of ephedrine administered intraoperatively for the treatment of hypotension, measured in milligrams (mg).
Measured: From induction of anesthesia until the end of surgery
Number of participants requiring intraoperative ephedrine administration
Number of participants who required ephedrine administration for the treatment of intraoperative hypotension.
Measured: From induction of anesthesia until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Jul 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrolaminar BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hatem saber mohamed ali, Professor, Study chair, Faculty of Medicine, Mansoura UniversityNaglaa A Elnegeery, Associate Professor, Study chair, Faculty of Medicine, Mansoura UniversityOla Shawky Naguib El Nagar, Lecturer, Study director, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720817
- Sponsor's protocol ID
- Retrolamianr and TAP blocks
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided