Opioid Free Anesthesia for Laparoscopic Cholecystectomy

NCT06202664 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: F.3-2/2022(ERRB)/PIMS
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Keywords

Opioid Free Anesthesia; Erector Spinae Block; Laparoscopic Cholecystectomy; Intraoperative Hemodynamics; Post operative analgesia

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

Secondary Outcomes (2)

• Intra operative rescue Opioid consumption

  Amount of Fentanyl given Intravenously from the time till skin incision to the time at end of surgery

• Post operative analgesic consumption

  From arrival in the PACU till 6 hours.

Study Arms (2)

Opioid Free Anesthesia Group

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.

Procedure: Erector Spinae Block

Conventional Opioid group

ACTIVE COMPARATOR

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

Drug: Opioid Analgesic

Interventions

Erector Spinae Block PROCEDURE

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.

Also known as: Opioid free anesthesia

Opioid Free Anesthesia Group

Opioid Analgesic DRUG

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).

Also known as: Conventional Opioid based analgesia

Conventional Opioid group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muhammad Haroon Anwar: lead
• Pakistan Institute of Medical Sciences: collaborator

Study Sites (1)

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

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 35497703 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Muhammad Haroon Anwar, MBBS

  Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Anaesthesia and Critical Care Medicine

Model Details: Patients enrolled will be divided into two groups through computer generated random numbers. Standard ASA monitoring will be done. Intervention will be done at the time of induction of anesthesia that is opioid based analgesia vs Erector Spinae block bilaterally at T6 level. In both groups intra-operative rise in Heart Rate or Blood Pressure or both by more than 20% from baseline value particularly upon skin incision and generation of pneumoperitoneum will indicate inadequate analgesia. This will then be supplemented with 0.5 Mcg/kg of IV Fentanyl increments along with 1g IV Paracetamol and 30 mg IV Ketorolac . Post operatively if VAS score is greater than 4 then rescue analgesia in the form of 1g of IV Paracetamol will be given. This will be supplemented with 15 mg of IV Ketorolac if VAS score is greater than 6. IV Tramadol at dose of 50mg will be given if the VAS score is greater than 8.

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: January 15, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)