A Clinical Study to Compare Nerve block in Right Upper Side of Abdomen Performed using Ultrasound and Laparoscopy for Postoperative Pain Relief

Completed

• Conditions: Calculus of gallbladder and bile duct with cholecystitis,

• Registration Number: CTRI/2019/01/017255
• Lead Sponsor: SRM medical College Hospital

Brief Summary

Patients posted Laparoscopic cholecystectomy that fulfills the inclusion criteria will be enrolled in this study after obtaining ethical committee clearance. Patients will be randomly allocated into two groups, Group A and Group B, with 40 patients in each group. At the end of surgery, Group A patients will receive Ultrasound guided bilateral subcostal  Transversus Abdominis Plane (TAP) block with Ropivacaine 0.2% 20 ml. Group B patients will receive laparoscopic guided bilateral subcostal TAP block with Ropivacaine 0.2% 20 ml.  The patient will be monitored by the anaesthesiologist in PACU who will be blinded to the group involved.

All patients will be premedicated with Tab. Alprazolam 0.5 mg PO 2 hrs before being shifted to the operating theatre. Patient’s vitals will be monitored with pulse oximetry, NIBP, and ECG. All the patients will receive general anaesthesia with endotracheal intubation which will be standardized. Patients will be induced with Propofol 2mg/kg and vecuronium 0.1 mg/kg as the muscle relaxant. Morphine 0.15 mg/kg iv will be the intraoperative analgesic. Anaesthesia will be maintained with Sevoflurane and vecuronium.

At the end of surgery, the patient will receive either ultrasound (Group A) or laparoscopic guided (Group B) TAP block. After taking proper aseptic precautions, TAP block will be given using 20 ml of 0.2% Ropivacaine. The patient will be extubated after performing the block and shifted to recovery. The patient will be shifted to PACU when Aldrete recovery criteria are satisfied. The patient will be continuously monitored in PACU for 24 hours. The pain will be assessed by visual analog scale (VAS), measured at rest with 0 being no pain and 10 being worst pain possible.

The duration of postoperative analgesia is defined as the time taken from the completion of TAP block to the first request for postoperative analgesia (VAS > 3). The patient will be started on Patient Controlled Analgesia pump with morphine bolus dose of 1 mg and lockout interval of 10 minutes. The patient will be instructed to have bolus when VAS is more than 3. The total consumption of morphine is noted. The occurrence of any adverse effects like nausea, vomiting, itching and respiratory depression will be noted and treated accordingly.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Study Completion: 2019-09-30
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with ASA Physical Status I and II posted for unilateral laparoscopic cholecystectomy.
• Weighing between 60 – 100 kg.

Exclusion Criteria

• All patients with ASA Physical Status III and above 2.
• Patients who refuse to participate in the study 3.
• Patients who are allergic to amide local anaesthetics 4.
• Patients who are pregnant 5.
• Patients with chronic cardiac, renal or hepatic condition 6.
• Patients with coagulation abnormalities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of postoperative analgesia	Time taken from the block completion to the first request for postoperative analgesia

Secondary Outcome Measures

Name	Time	Method
Consumption of analgesics	Total consumption of Morphine in the PCA pump for 24 hours is calculated

Trial Locations

Locations (1)

SRM medical college hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

SRM medical college hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Rajagopalan Venkatraman

Principal investigator

9894581455

drvenkat94@gmail.com