--- title: Opioid Free Anesthesia for Laparoscopic Cholecystectomy nct_id: NCT06202664 overall_status: COMPLETED phase: PHASE4 sponsor: Muhammad Haroon Anwar study_type: INTERVENTIONAL primary_condition: Analgesia countries: Pakistan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06202664.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06202664" ct_last_update_post_date: 2024-10-01 last_seen_at: "2026-05-12T07:23:14.485Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Opioid Free Anesthesia for Laparoscopic Cholecystectomy **Official Title:** Opioid Free Anesthesia for Laparoscopic Cholecystectomy; A Randomized Control Trial at a Tertiary Care Hospital **NCT ID:** [NCT06202664](https://clinicaltrials.gov/study/NCT06202664) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 72 - **Lead Sponsor:** Muhammad Haroon Anwar - **Collaborators:** Pakistan Institute of Medical Sciences - **Conditions:** Analgesia - **Start Date:** 2024-01-15 - **Completion Date:** 2024-08-31 - **CT.gov Last Update:** 2024-10-01 ## 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 - **Minimum age:** 16 Years - **Maximum age:** 80 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` 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. ``` ## Arms - **Opioid Free Anesthesia Group** (EXPERIMENTAL) — 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. - **Conventional Opioid group** (ACTIVE_COMPARATOR) — Patient entering this group through computer generated random numbers will receive opioid based anesthesia. ## Interventions - **Erector Spinae Block** (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. - **Opioid Analgesic** (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). ## Primary Outcomes - **Heart Rate** _(time frame: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery.)_ — 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). - **Blood Pressure** _(time frame: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery)_ — 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. - **Post operative pain control** _(time frame: 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.)_ — This will be assessed using Visual Analog Scale (VAS) ## Secondary Outcomes - **Intra operative rescue Opioid consumption** _(time frame: Amount of Fentanyl given Intravenously from the time till skin incision to the time at end of surgery)_ - **Post operative analgesic consumption** _(time frame: From arrival in the PACU till 6 hours.)_ ## Locations (1) - Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences, Islamabad, Federal, Pakistan ## Recent Field Changes (last 30 days) - `armsInterventions.arms` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.deparment of anesthesia and critical care medicine, pakistan institute of medical sciences|islamabad|federal|pakistan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06202664.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06202664* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*