To assess the efficacy of intraperitoneal 0.25% levobupivacaine for postoperative analgesia following laparoscopic cholecystectomy

Phase 1

Completed

Conditions: Diseases of the digestive system,

Registration Number: CTRI/2019/08/020837

Lead Sponsor: Pavithra Palaniappan

Brief Summary: Laparoscopic cholecystectomy is currently the most practised surgical technique for cholelithiasis. After laparoscopic cholecystectomy pain is due to somatic pain, visceral pain and referral pain. Postoperative analgesia should cover all these factors. In this study somatic pain is attended with port site local infiltration. Visceral pain and referral pain if left unattended then the patient will need intravenous analgesics. Intraperitoneal local anaesthetic will attend to visceral pain and referral pain.

The study group patients get intraperitoneal local anaesthetic(0.25% levobupivacaine) and placebo group receives intraperitoneal normal saline. Postoperative pain is assessed using VAS score and postoperative intravenous analgesic usage on patientâ€™s request in the first 24 hours is recorded.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 56

Inclusion Criteria

Patients undergoing laparoscopic cholecystectomy Patients of ASA1 and ASA 2.

Exclusion Criteria

Patients allergic to local anaesthetics Patients with severe cardiac, pulmonary, and neurological disease Patients in whom procedure has to be converted to open cholecystectomy Patients in whom abdominal drain will be kept Patients of weight less than 50 kg Patients not willing to participate.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time for the first request of analgesia within first 24 hours	Time for the first request of analgesia within first 24 hours

Secondary Outcome Measures

Name	Time	Method
Post operative VAS score	Total no. of analgesics used in first 24 hrs

Trial Locations

Locations (1): Sri Ramachandra Institute of higher education and research
🇮🇳
Chennai, TAMIL NADU, India
Sri Ramachandra Institute of higher education and research
🇮🇳Chennai, TAMIL NADU, India
Pavithra Palaniappan
Principal investigator
7502891567
pavicardo@gmail.com