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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dina Salem, MD
  • Phone Number: 002 01099333513

Study Contact Backup

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

Study Locations

  • Egypt
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Retrosuperior costotransverse ligament block group
The patient will receive retrosuperior costotransverse ligament block
Procedure: Retrosuperior costotransverse ligament block group
The patient will receive retrosuperior costotransverse ligament block
Active Comparator: Erector spinae block group
The patient will receive erector spinae block.
Procedure: Erector spinae block group
The patient will receive erector spinae block.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zagazig University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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