Perioperative Opioid-sparing Effect of Retrosuperior Costotransverse Ligament Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy

December 11, 2025 updated by: Dina Abdelhameed Elsadek Salem, Zagazig University

Perioperative Opioid-sparing Effect of Retrosuperior Costotransverse Ligament Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy: A Randomized Clinical Trial.

This study aims to compare the analgesic effect of retro superior costotransverse ligament space block vs erector spinae plane block to Achieve high-quality perioperative opioid-sparing effect and postoperative analgesia after laparoscopic cholecystectomy with optimum hemodynamic stability and high patient and surgeon satisfaction

Study Overview

Detailed Description

This study aims to compare between retro superior costotransverse ligament space block vs erector spinae plane block

  • To compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption and pain scores by NRS)
  • To assess the block performance time required to perform each technique .
  • To compare intraoperative parameters (hemodynamics and intraoperative fentanyl consumption)
  • To assess patient, surgeon satisfaction and complications of the block.

Study Type

Interventional

Enrollment (Estimated)

80

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: Dina Salem, MD
  • Phone Number: 002 01099333513

Study Contact Backup

  • Name: Marwa Medhat, MD
  • Phone Number: 002 01002828937

Study Locations

      • Zagazig, Egypt
        • Recruiting
        • Faculty of human medicine, Zagazig university, Zagazig
        • Contact:

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

Yes

Description

Inclusion Criteria:

  1. patient acceptance
  2. Age: 21-64 years old.
  3. Sex: both sexes.
  4. Physical status: ASA I & II.
  5. Body mass index (BMI): 18.5 - 30 kg/m2.
  6. Type of operations: elective laparoscopic cholecystectomy.
  7. Duration of surgery not more than 2 hours.

Exclusion Criteria:

  1. Known hypersensitivity to lidocaine or bupivacaine.
  2. Patients with respiratory insufficiency.
  3. Coagulation disorders or taking drugs affect surgical hemostasis.

7. Patients with pre-existing neurological deficits. 8. Uncooperative patient or with altered mental status. 9. Patient with advanced cardiovascular or respiratory diseases

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
Active Comparator: Retrosuperior costotransverse ligament block group
The patient will receive retrosuperior costotransverse ligament block
The patient will receive retrosuperior costotransverse ligament block
Active Comparator: Erector spinae block group
The patient will receive erector spinae block.
The patient will receive erector spinae block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to first call to rescue analgesia
Time Frame: 24 hours
The time to first call to rescue analgesia( the interval between the block injection till the NRS more than or equal 4) (naluphine) will be recorded
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess block characteristics (block performance time)
Time Frame: 1 hour
To assess block characteristics (block performance time) in minutes
1 hour
Total intraoperative fentanyl consumption
Time Frame: duration of surgery (up to 2 hours)
Total intraoperative fentanyl required other than the induction dose in micrograms
duration of surgery (up to 2 hours)
Pain intensity by Numerical Rating Scale
Time Frame: 30 minutes after arrival to post anesthesia care unit , 2hours, 4hours, 6hours, 8hours, 12hours, 18 hours and 24hours postoperative
Analgesic parameters (Pain intensity at rest and at movement) by using Numerical Rating Scale (NRS) which will explained to patient as follows:0=no pain and 10= worst pain
30 minutes after arrival to post anesthesia care unit , 2hours, 4hours, 6hours, 8hours, 12hours, 18 hours and 24hours postoperative
total amount of rescue analgesia
Time Frame: 24 hours
total amount of rescue analgesia if NRS≥4. in the first 24 hours.
24 hours
Intraoperative hemodynamics (Heart Rate and Mean Arterial Pressure)
Time Frame: every 5 minutes in the first 30 minutes then every 10 minutes till the end of surgery
Intraoperative hemodynamics every 5 minutes in the first 30 minutes then every 10 minutes till the end of surgery
every 5 minutes in the first 30 minutes then every 10 minutes till the end of surgery
Patient's satisfaction
Time Frame: 24 hours
all patient's satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)
24 hours
complication of the block
Time Frame: 24 hours
complication of the block( heamatoma,local anesthetic toxicity,infection)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (Actual)

December 10, 2025

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

July 10, 2026

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

November 29, 2025

First Posted (Estimated)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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