Opioid Free Anesthesia for Laparoscopic Cholecystectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Erector Spinae Block; Drug: Opioid Analgesic

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opioid Free Anesthesia Group; 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.	Procedure: Erector Spinae Block; Erector Spinae block under ultrasound guidance will be administered bilaterally at T6 level. The block will be administered after induction of general anesthesia with 1mg of IV Midazolam, 2mg/kg of IV Propofol and 0.5 mg/kg of IV Atracurium. After induction patient will be placed in lateral position and then under ultrasound guidance Erector Spinae Block will be administered at T6 level. Drugs administered in the block will include 30ml of 0.25% Bupivacaine and 10ml of 1% Lignocaine (bilaterally). Skin incision for trocar insertion will be given 15 mins after administration of Erector Spinae Block.; Other Names: Opioid free anesthesia
Active Comparator: Conventional Opioid group; Patient entering this group through computer generated random numbers will receive opioid based anesthesia.	Drug: Opioid Analgesic; This group of patient will receive general anesthesia induction with 1mcg/kg of IV Fentanyl, 2mg/kg of IV Propofol and 0.5 mg/kg of IV Atracurium. 1g of IV paracetamol and 30 mg of IV Ketorolac will be given if intra-operative course suggest inadequate analgesia (Rise in Heart rate ± Blood Pressure by more than 20% from baseline).; Other Names: Conventional Opioid based analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain control	This will be assessed using Visual Analog Scale (VAS)	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.
Heart Rate	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).	Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery.
Blood Pressure	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.	Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra operative rescue Opioid consumption	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.	Amount of Fentanyl given Intravenously from the time till skin incision to the time at end of surgery
Post operative analgesic consumption	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.	From arrival in the PACU till 6 hours.

Collaborators and Investigators

• Sponsor: Muhammad Haroon Anwar
• Collaborators: Pakistan Institute of Medical Sciences
• Investigators: Principal Investigator: Muhammad Haroon Anwar, MBBS, Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad

Publications and helpful links

General Publications

• Ragupathy R, Prabhu SCG, Thiyagarajan D, Anto V. Opioid-free anaesthesia for laparoscopic surgeries - A prospective non-randomised study in a tertiary care hospital. Indian J Anaesth. 2022 Mar;66(3):207-212. doi: 10.4103/ija.ija_785_21. Epub 2022 Mar 24.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: January 1, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Erector Spinae Block; Laparoscopic Cholecystectomy; Opioid Free Anesthesia; Post operative analgesia; Intraoperative Hemodynamics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Narcotics; Analgesics, Opioid; Analgesics
• Other Study ID Numbers: F.3-2/2022(ERRB)/PIMS

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes