Clinical trial

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

NCT06202664

Name

F.3-2/2022(ERRB)/PIMS

Description

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.

Trial arms

Trial start

2024-01-15

Estimated PCD

2024-09-15

Trial end

2024-09-15

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Opioid Free Anesthesia Group

Other names:

Opioid free anesthesia

Opioid Analgesic

This group of patient will receive general anesthesia induction with 1mg of IV Midazolam, 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 towards the end of surgery if suggested by intra-operative course.

Arms:

Conventional Opioid group

Other names:

Conventional Opioid based analgesia

Size

Primary endpoint

Heart Rate

Pre-induction, immediately after induction of anesthesia , immediately after skin incision, after generation of pneumoperitoneum, and at the end of surgery.

Blood Pressure

Pre-induction, immediately after induction of anesthesia , immediately after skin incision, after generation of pneumoperitoneum, and at the end of surgery.

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.

Eligibility criteria

Inclusion Criteria: * Age: 16 years to 70 years. * American Society of Anesthesiologists (ASA) class: I, II and III. * Elective Laparoscopic Cholecystectomy under General Anesthesia. Exclusion Criteria: * ASA class IV or above * Neuromuscular disease * Body mass index \>40 kg/m2 * known allergy to drugs used in the study * Ischemic Heart disease, Cardiac Failure, Liver and renal insufficiency

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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. Intra-operatively a 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. Paracetamol and Ketorolac will be given towards the end of surgery if dictated by intra-operative course. Post operatively if VAS score is greater than 4 then rescue analgesia in the form of 1g of IV paracetmaol will be given. This will be supplemented with 30 mg of Ketorolac if VAS score is greater than 6. 50mg of IV Tramadol will be given if the VAS score is greater than 8.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}

Updated at

2024-02-06

1 organization

1 product

1 indication

Organization

Muhammad Haroon Anwar

Product

Opioid Analgesic

Indication

Analgesic