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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
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 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.

mohamed elnagar Mohamed A. Elnagar MB BCh, MB BCh contact

+20 1009344804

melnaggar789@gmail.com

Egypt1 site, 1 recruiting
  • Mansoura University

    Al Mansurah, Dakahlia Governorate

    mohamed a Mohamed A. Elnagar MB BCh, MB BCh, +20 1009344804, melnaggar789@gmail.com

    Recruiting

Other trials in Egypt

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 groups in NCT07720817
Study groupRoleWhat they receive
Retrolaminar Block GroupExperimentalPatients 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 GroupActive comparatorPatients 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. Number of participants with postoperative nausea

    Number of participants who experienced postoperative nausea

    Measured: From the end of surgery to 24 hours after surgery

  9. Number of participants with postoperative vomiting

    Number of participants who experienced postoperative vomiting

    Measured: From the end of surgery to 24 hours after surgery

  10. Number of participants with postoperative shivering

    Number of participants who experienced postoperative shivering

    Measured: From the end of surgery to 24 hours after surgery

  11. Number of participants with postoperative hypotension

    Number of participants who experienced postoperative hypotension

    Measured: From the end of surgery to 24 hours after surgery

  12. Number of participants with postoperative bradycardia

    Number of participants who experienced postoperative bradycardia

    Measured: From the end of surgery to 24 hours after surgery

  13. Number of participants with postoperative headache

    Number of participants who experienced postoperative headache

    Measured: From the end of surgery to 24 hours after surgery

  14. 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

  15. 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.

  1. First posted22 Jul 2026
  2. Study start1 Jul 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionFeb 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
164 participants (estimated)
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

Questions about this trial

What is this clinical trial studying?

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.

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 8 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: looking for participants now, as of the sponsor's last update on 16 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 Egypt. 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 mohamed elnagar Mohamed A. Elnagar MB BCh, MB BCh (+20 1009344804, melnaggar789@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The postoperative Quality of Recovery-15 score (time frame: 24 hour postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 Sep 2026.

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