Completed

Opioid Free Anesthesia for Laparoscopic Cholecystectomy; A Randomized Control Trial at a Tertiary Care Hospital

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What is being tested

Erector Spinae Block

+ Opioid Analgesic

ProcedureDrug
Who is being recruted

Agnosia+4

+ Nervous System Diseases

+ Neurologic Manifestations

From 16 to 80 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorMuhammad Haroon Anwar
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2024

Actual date on which the first participant was enrolled.

This study is exploring a new approach to anesthesia for patients undergoing laparoscopic cholecystectomy, a common surgery to remove the gallbladder due to gallstones. Typically, this surgery involves the use of opioids to manage pain, but opioids can cause side effects like nausea, vomiting, and breathing difficulties, which can slow down recovery. This research aims to see if an alternative method, known as opioid-free anesthesia, can help patients recover faster by avoiding these side effects. Specifically, the study will use a technique called erector spinae block, which involves a type of regional anesthesia that might offer effective pain control without the need for opioids. Participants in the study will receive the erector spinae block as part of their anesthesia during surgery. Researchers will monitor the effectiveness of this method for controlling pain both during and after the operation. The goal is to determine if this approach provides sufficient pain relief without the drawbacks associated with opioids, possibly leading to a quicker recovery and shorter hospital stay. By comparing the outcomes with traditional opioid-based anesthesia, the study hopes to demonstrate the potential benefits and safety of opioid-free anesthesia for patients undergoing this common surgical procedure.

Official TitleOpioid Free Anesthesia for Laparoscopic Cholecystectomy; A Randomized Control Trial at a Tertiary Care Hospital
NCT06202664
Principal SponsorMuhammad Haroon Anwar
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AgnosiaNervous System DiseasesNeurologic ManifestationsPerceptual DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations

Criteria

4 inclusion criteria required to participate
Age: 16 years to 80 years.

American Society of Anesthesiologists (ASA) class: I and II.

Elective Laparoscopic Cholecystectomy under General Anesthesia.

Duration of surgery being less than 1h

6 exclusion criteria prevent from participating
ASA class III or above

Neuromuscular disease

Body mass index >35 kg/m2

known allergy to drugs used in the study

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This will be the experimental group. Patient entering this group through computer generated random numbers will receive opioid free anesthesia in form of ultrasound guided Erector Spinae Block given bilaterally at T6 level.

Group II

Active Comparator
Patient entering this group through computer generated random numbers will receive opioid based anesthesia.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences

Islamabad, PakistanOpen Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences in Google Maps
CompletedOne Study Center