Opioid Free Anesthesia for Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Erector Spinae Block

Intervention Type 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.

Conventional Opioid group

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

Group Type ACTIVE_COMPARATOR

Opioid Analgesic

Intervention Type 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).

Interventions

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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.

Intervention Type PROCEDURE

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).

Intervention Type DRUG

Other Intervention Names

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Opioid free anesthesia Conventional Opioid based analgesia

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes