- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07598162
RLB vs ERSP for Postoperative Analgesia in Lap Cholecystectomy
May 18, 2026 updated by: Esraa Abdallah Mohamed, Sohag University
Retrolaminar Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Comparative Randomized Prospective Study
This prospective, randomized, double-blind clinical trial evaluates the comparative effectiveness of ultrasound-guided retrolaminar block (RLB) and erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing laparoscopic cholecystectomy.
A total of 100 ASA I-II patients, aged 20-60 years, will be randomly allocated into two equal groups to receive either RLB or ESPB bilaterally following induction of standardized general anesthesia.
The primary outcome is the time to first request for rescue analgesia, while secondary outcomes include total morphine consumption within the first 24 hours, postoperative pain scores assessed using the Numeric Rating Scale (NRS), patient satisfaction, and the incidence of adverse events.
Pain assessment will be performed at predefined intervals over the first 24 hours postoperatively.
The study aims to determine which technique provides superior analgesia with reduced opioid requirements and improved patient outcomes.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esraa abdallah Mohamed, resident
- Phone Number: 01066981675
- Email: esraa97egy@gmail.com
Study Locations
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Sohag, Egypt
- Sohag Faculty of Medicine
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Contact:
- Esraa abdallah Mohamed, resident
- Phone Number: 01066981675
- Email: esraa97egy@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Age from 20 to 60 years.
- Both sexes.
- American Society of Anesthesiology (ASA) grade I and II physical status.
- Patients will undergo cholecystectomy under general anesthesia.
Exclusion Criteria:
• Sensitivities or contraindications to the study medications.
- Infection at the site of injection.
- Emergency surgery.
- Body mass index (BMI) > 35.
- Organic comorbidities.
- Histories of psychological conditions and/or chronic pain syndromes.
- Contraindications to regional anesthesia.
- Severe respiratory, cardiac, hepatic and renal disorders.
- Pregnancy.
- Coagulopathy.
- Opioid addiction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: ESPB group
|
The blocks will be conducted at the level of the T7 spinous process (SP) with the patient in the lateral position and the arm abducted.
Using US ( curved probe ) , the T7 transverse process (TP) is identified by counting from the 12th rib.
The US probe is positioned 2 - 3 cm laterally to the SP of T7 and situated over the TP of T7/T8 in the parasagittal longitudinal plane, with the erector spinae muscle (ESM) visualized over the TP.
The needle is then inserted and advanced in plane from cephalad to caudad until the needle tip contacts the TP of T7.
Following hydro dissection with 2 mL of isotonic saline, which elevates the ESM, 20 mL of LA mixture is administered after several negative aspirations.
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Active Comparator: RLB group
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Patients will be positioned laterally, and a curved ultrasound probe will be aligned longitudinally at the T7 vertebra.
The vertebral lamina and spinous process will be identified.
A needle will be inserted 1 - 1.5 cm lateral to the spinous process, advanced toward the lamina, and 20 mL of LA mixture will be injected into the fascial plane between the lamina and transversus spinae muscles bilaterally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Time to the 1st rescue analgesia
Time Frame: in the 1st 24hr.
|
in the 1st 24hr.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: in the 1st 24hr.
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in the 1st 24hr.
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Pain score.
Time Frame: Pain will be assessed at, 2, 4, 6, 8, 12, 18 and 24 hour postoperatively.
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postoperative pain assessment with the Numeric Rating Scale (NRS).
Numeric rating scale .. zero represents no pain while 10 represents the worst pain imaginable
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Pain will be assessed at, 2, 4, 6, 8, 12, 18 and 24 hour postoperatively.
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Degree of patient satisfaction
Time Frame: in the first 24 hours after surgery
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• Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1 represents extremely dissatisfied 2 represesnts unsatisfied; 3 represents neutral 4 represents satisfied 5 represents extremely satisfied)
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in the first 24 hours after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
May 1, 2026
First Submitted That Met QC Criteria
May 18, 2026
First Posted (Actual)
May 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- soh-Med-26-3-9MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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