Clinical trial NCT06202664: Opioid Free Anesthesia for Laparoscopic Cholecystectomy
Official title: Opioid Free Anesthesia for Laparoscopic Cholecystectomy; A Randomized Control Trial at a Tertiary Care Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Keywords: Opioid Free Anesthesia
Erector Spinae Block
Laparoscopic Cholecystectomy
Intraoperative Hemodynamics
Post operative analgesia
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Pakistan Institute of Medical Sciences
First posted: 2024-01-11
Enrollment: 72
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heart Rate
timeFrame: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery.
measure: Blood Pressure
timeFrame: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery
measure: Post operative pain control
timeFrame: 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:
measure: Intra operative rescue Opioid consumption
timeFrame: Amount of Fentanyl given Intravenously from the time till skin incision to the time at end of surgery
measure: Post operative analgesic consumption
timeFrame: From arrival in the PACU till 6 hours.
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences
state: Federal
Study officials:
affiliation: Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad
name: Muhammad Haroon Anwar, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.