Opioid Free Anesthesia for Laparoscopic Cholecystectomy

Phase 4

Completed

• Conditions: Analgesia
• Interventions: Procedure: Erector Spinae Block; Drug: Opioid Analgesic

• Registration Number: NCT06202664
• Lead Sponsor: Muhammad Haroon Anwar

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-01
• Study First Posted: 2024-01-11
• Study Start: 2024-01-15
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Free Anesthesia Group	Erector Spinae Block	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.
Conventional Opioid group	Opioid Analgesic	Patient entering this group through computer generated random numbers will receive opioid based anesthesia.

Primary Outcome Measures

Name	Time	Method
Heart Rate	Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery.	Heart Rate is measured as a part of standard ASA monitoring through electronic cardiac monitor showing electrocardiogram as well as heart rate (no. of beats/min).
Blood Pressure	Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery	Blood pressure including Systolic, Diastolic and Mean arterial pressure is measured as a part of standard ASA monitoring. This is measured in units of mm of Hg through automated Non-invasive Blood pressure monitoring device.
Post operative pain control	This will be assessed upon patient arrival at Post anesthesia care unit and then 1 hourly interval till 6hours. The pain will be assessed both on rest as well as on cough.	This will be assessed using Visual Analog Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Intra operative rescue Opioid consumption	Amount of Fentanyl given Intravenously from the time till skin incision to the time at end of surgery	This will be assessed in terms of micro-grams of Fentanyl consumed intra-operatively in addition to the amount of drug given at induction in control group.
Post operative analgesic consumption	From arrival in the PACU till 6 hours.	This will be assessed in terms of amount of Tramadol, Ketorolac and Paracetamol consumed in the first 6 hours following surgery as dictated by Visual Analog Scale pain score.

Trial Locations

Locations (1)

Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences; 🇵🇰 Islamabad, Federal, Pakistan