Opioid Free Anesthesia for Laparoscopic Cholecystectomy

Muhammad Haroon Anwar

Status and phase: Completed; Phase 4

Conditions: Analgesia

Treatments: Drug: Opioid Analgesic; Procedure: Erector Spinae Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06202664

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Opioid Free Anesthesia Group

Experimental group

Description:

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.

Treatment:

Procedure: Erector Spinae Block

Conventional Opioid group

Active Comparator group

Description:

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

Treatment:

Drug: Opioid Analgesic