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
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07720817
- Acronym / sponsor ID
- Retrolamianr and TAP blocks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrolaminar Block Group | Experimental | Procedure: Ultrasound-guided Retrolaminar Block groupPatients will receive an ultrasound-guided retrolaminar block using 20 ml of 0.25% of bupivacaine administered at the T7 level at both sides |
| Transverses Abdominis Plane (TAP) Block Group | Active comparator | Procedure: Transverses Abdominis Plane (TAP) Block GroupPatients will receive an ultrasound-guided TAP block using 20 ml of 0.25% bupivacaine at both sids |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided Retrolaminar Block groupUltrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic. | Procedure or surgery | Retrolaminar Block Group |
| Transverses Abdominis Plane (TAP) Block GroupUltrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic. | Procedure or surgery | Transverses Abdominis Plane (TAP) Block Group |
Primary outcome
The postoperative Quality of Recovery-15 score
Time frame: 24 hour postoperative
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.
15 secondary outcomes
Numeric Rating Scale (NRS) at rest and during coughing
Time frame: 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
Time frame: From the end of surgery to 24 hours after surgery.
Time to first postoperative opioid analgesic request (hours)
Time frame: From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
Duration of hospital stay
Time frame: From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
Mean intraoperative mean arterial pressure (mmHg)
Time frame: 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)
Time frame: 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 (%)
Time frame: 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
Time frame: From the end of surgery to 24 hours after surgery
Number of participants with postoperative vomiting
Time frame: From the end of surgery to 24 hours after surgery
Number of participants with postoperative shivering
Time frame: From the end of surgery to 24 hours after surgery
Number of participants with postoperative hypotension
Time frame: From the end of surgery to 24 hours after surgery
Number of participants with postoperative bradycardia
Time frame: From the end of surgery to 24 hours after surgery
Number of participants with postoperative headache
Time frame: From the end of surgery to 24 hours after surgery
Total intraoperative ephedrine dose administered (mg)
Time frame: From induction of anesthesia until the end of surgery
Number of participants requiring intraoperative ephedrine administration
Time frame: From induction of anesthesia until the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Retrolaminar Block
Recruiting
Modified Thoracolumbar Interfascial Plane Block vs Retrolaminar Block for Pain in Lumbar Spine Surgeries
Postoperative Pain After Spinal Surgery
Recruiting
Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy
Post Operative Pain
Recruiting
Retrolaminar Block Versus Subcostal Transversus Abdominis Plane Block in Liver Resection Surgery
Cancer Liver
Not yet recruiting
Retrolaminar Plane Block Versus Anterior Quadratus Lumborum Block in Pediatric Urogenital Surgery
Pediatric Regional Anesthesia, Retrolaminar Block
Recruiting
Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia
Acute Pain, Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
hatem saber mohamed ali, Professor study chair
Faculty of Medicine, Mansoura University
Naglaa A Elnegeery, Associate Professor study chair
Faculty of Medicine, Mansoura University
Ola Shawky Naguib El Nagar, Lecturer study director
Faculty of Medicine, Mansoura University
1 site in 1 country: see every site and its status.
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.