Opioid Free Anesthesia for Laparoscopic Cholecystectomy

Last updated: September 27, 2024
Sponsor: Muhammad Haroon Anwar
Overall Status: Completed

Phase

4

Condition

Pain

Treatment

Erector Spinae Block

Opioid Analgesic

Clinical Study ID

NCT06202664
F.3-2/2022(ERRB)/PIMS
  • Ages 16-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this interventional study is to check the efficacy of Erector Spinae block as Opioid Free Anesthesia for Laparoscopic Cholecystectomy. Laparoscopic Cholecystectomy is a commonly performed day care procedure. Being a day care procedure the anesthetic technique employed should provide adequate analgesia, allow early mobilization of patient and should mitigate nausea and vomiting which occurs quite frequently in this surgical population. If these goals are achieved patients can be discharged early from hospital setting and this leads to overall cost benefits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • ASA class III or above

  • Neuromuscular disease

  • Body mass index >35 kg/m2

  • known allergy to drugs used in the study

  • Ischemic Heart disease, Cardiac Failure, Liver and renal insufficiency

  • Intra-operative conversion from laparoscopic to open procedure.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Erector Spinae Block
Phase: 4
Study Start date:
January 15, 2024
Estimated Completion Date:
August 31, 2024

Study Description

One of the commonest presentations to surgical department is the abdominal pain caused by gall stones. The procedure of choice for treatment of cholelithiasis is Laparoscopic Cholecystectomy; a day care surgical procedure. This is performed under General Anesthesia with Endotracheal tube. During the surgery, anesthetist provides multi-modal analgesia in the form of opioids, NSAIDs and paracetamol. The commonly used Opioids in our setting include Morphine, Fentanyl and Nalbuphine. Opioids provides excellent analgesia but are associated with a number of side effects such as sedation, euphoria or dysphoria, respiratory depression, nausea, vomiting and increase in smooth muscle tone of the gut. These side effects can significantly impair the recovery in post-operative period, leading to prolong hospital stay. As a result opioid free anesthesia could be a suitable alternative to conventional opioid anesthesia for laparoscopic cholecystectomy. By avoiding the adverse effects of opioids; Opioid free anesthesia can lead to early recovery and discharge from the hospital.

One way to provide opioid free anesthesia is by utilizing loco-regional techniques. One of the loco-regional technique which has shown some benefit in laparoscopic cholecystectomy is erector spinae block. However in the available literature the block was utilized for providing post-operative analgesia in laparoscopic cholecystectomy. This Randomized Control Trial will check the efficacy of Erector Spinae Block in providing intra-operative as well as post operative analgesia in patients undergoing laparoscopic cholecystectomy.

Connect with a study center

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

    Islamabad, Federal 44000
    Pakistan

    Site Not Available

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