Opioid Free Anesthesia for Laparoscopic Cholecystectomy

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202664
• Other study ID #: F.3-2/2022(ERRB)/PIMS
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: February 2024
• Source: Pakistan Institute of Medical Sciences
• Contact: Muhammad Haroon Anwar, MBBS
• Phone: +92-333-5236956
• Email: haroonanwar22[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

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.

Drug:
• 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.

Locations

Country	Name	City	State
Pakistan	Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences	Islamabad	Federal

Sponsors (2)

Lead Sponsor	Collaborator
Muhammad Haroon Anwar	Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Pre-induction, immediately after induction of anesthesia , immediately after skin incision, after generation of pneumoperitoneum, and at the end of surgery.
Primary	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.	Pre-induction, immediately after induction of anesthesia , immediately after skin incision, after generation of pneumoperitoneum, and at the end of surgery.
Primary	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.