- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07276646
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
Status
Recruiting
Conditions
Intervention / Treatment
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:
- Dina Salem, MD
- Phone Number: 002 01099333513
- Email: dinamaghraby@yahoo.com
-
-
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:
- patient acceptance
- Age: 21-64 years old.
- Sex: both sexes.
- Physical status: ASA I & II.
- Body mass index (BMI): 18.5 - 30 kg/m2.
- Type of operations: elective laparoscopic cholecystectomy.
- Duration of surgery not more than 2 hours.
Exclusion Criteria:
- Known hypersensitivity to lidocaine or bupivacaine.
- Patients with respiratory insufficiency.
- 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.
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 (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
Keywords
Other Study ID Numbers
- 1783
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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