Comparison of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) versus Port- Site local Infiltration and Opioid based Analgesia in Laparoscopic Cholecystectomy: A Prospective, Randomized Control Study"
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Degutla Karthik Chary
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Postoperative pain scores using Numeric Rating Scale (NRS, 0–10)
Overview
Brief Summary
This randomized, parallel group, active controlled clinical trial will evaluate the analgesic efficacy of ultrasound guided Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M TAPA) compared with conventional port site infiltration with local anesthetic in patients undergoing laparoscopic cholecystectomy. 113 adult patients (ASA I to III, aged 18 to 75 years) scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomized into two groups. Group A will receive bilateral M TAPA block after induction of anesthesia, while Group B will receive conventional port site infiltration with local anesthetic. The primary outcome will be postoperative pain scores assessed using the Numeric Rating Scale at predefined time intervals up to 24 hours. Secondary outcomes include total opioid consumption, intraoperative and postoperative hemodynamic responses, incidence of postoperative nausea and vomiting, sedation scores, return of bowel function, and patient satisfaction. This study aims to determine whether M TAPA provides superior analgesia, reduces opioid requirements, and improves recovery compared to routine practice.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA Physical Status 1,2,3 Elective laparoscopic cholecystectomy under general anesthesia Patients who provide written informed consent.
Exclusion Criteria
- •Patient refusal ASA 4 or higher Emergency or open cholecystectomy Coagulopathy or anticoagulant therapy Local infection at block site Allergy to local anesthetics Chronic opioid use or chronic pain disorder Severe hepatic or renal impairment.
Outcomes
Primary Outcomes
Postoperative pain scores using Numeric Rating Scale (NRS, 0–10)
Time Frame: At immediate post operative period or 0 hours, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours post operatively.
Secondary Outcomes
- Total opioid consumption in 24 hours (IV tramadol/fentanyl equivalent) intraoperative and postopertive(cumulative intraoperative and postoperative)
- Hemodynamic response to surgical stimulus (MAP and HR)(At trocar insertion, 5, 10, 15 min after pneumoperitoneum, and at extubation)
- Hemodynamics in postoperative period (MAP and HR)(At 1, 2, 4, 8, 12, and 24 hours postoperatively)
- Incidence of postoperative nausea and vomiting (PONV)(0–24 hours postoperatively)
- Patient satisfaction score (Likert scale)(At 24 hours)
Investigators
Degutla Karthik Chary
Department of anaesthesiology