The post operative analgesic effects of dexamethasone versus ondansetron as adjuvant to 0.25% bupivacaine bupivacaine via intraperitoneal infiltration in patients undergoing elective laparoscopic cholecystectomy

Phase 3

Not yet recruiting

• Conditions: Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2023/05/052968
• Lead Sponsor: JSS HOSPITAL

Brief Summary

Asses for eligibility , patient will be selected based on the inclusion criteria, will be divided into three groups, Group D will receive 2ml 8mg dexamethasone, group O will receive 2ml of 4mg ondansetron and group c will receive 2ml normal saline along with 30ml 0,25% bupivacaine via intraperitoneal infiltration, general endotracheal anaestheisa will be administered to the patient and the surgery will be done, before extubation drugs will be infiltrated intraperitoneally by the general surgeon through the laparoscopic port over the gallbladder bed and diaphragmatic surface. after extubation postoperative monitoring will be done for pain and PONV, the effectiveness of the drug in reducing the incidence and severity of pain and PONV will be compared.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-19
• Study Start: 2023-05-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

ASA I-II Surgery duration up to or less than 2 hours.

Exclusion Criteria

• Patient using Steroids or NSAIDS Patients with IHD/ Rhythm abnormalities.
• Patients with significant hepatic, renal or hematological disorders.
• Patients allergic to study drugs Patients and his/her legally accepted representatives not willing to provide their voluntary written informed consent for participation in the study.
• Surgery lasting for more than 2 hours If the surgery gets converted to open cholecystectomy Pregnant patients Any patient with postoperative drain Patients with BMI > 30.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant reduction in post operative pain in patients who have received 8mg dexamethasone than 4mg ondansetron via intraperitoneal infiltration	IN A TIME PERIOD OF 24 HOURS POST SURGERY

Secondary Outcome Measures

Name	Time	Method
Reduction in postoperative nausea and vomiting	24 hours

Trial Locations

Locations (1)

JSS MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Mysore, KARNATAKA, India

JSS MEDICAL COLLEGE AND HOSPITAL

🇮🇳Mysore, KARNATAKA, India

DR VINEETHA M

Principal investigator

9447940700

vineetham92@gmail.com