Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine

Not Applicable

Completed

• Conditions: LAPAROSCOPIC CHOLECYSTECTOMY
• Interventions: Drug: Bupivacaine injection; Drug: Dexmedetomidine injection

• Registration Number: NCT06560892
• Lead Sponsor: RESnTEC, Institute of Research

Brief Summary

For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. This study was performed with the objective of comparing the mean duration of analgesia of intraperitoneal bupivacaine with dexmedetomidine to intraperitoneal bupivacaine alone in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-19
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Patients of either gender
• Aged between 20 and 70 years
• ASA (American Society of Anesthesiologists Classification) physical status I and II
• Undergoing Laparoscopic Cholecystectomy under general anesthesia

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Exclusion Criteria

• Patients sensitive to local anesthetics
• Patients with acute cholecystitis, choledocholithiasis, or ascending cholangitis (temperature≥38.6°C, serum bilirubin≥1.2mg/dl, and ultrasound showing common bile duct diameter of ≥1cm).
• Patients with uncontrolled diabetes (FBS≥110 mg/dl)
• Uncontrolled blood pressure (SBP≥140 mmHg)
• Ischemic heart disease (EF≤40%)
• Pulmonary dysfunction (FEV≤70 percent of normal)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine + Dexmedetomidine group	Bupivacaine injection	Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml
Bupivacaine group	Bupivacaine injection	Patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline
Bupivacaine + Dexmedetomidine group	Dexmedetomidine injection	Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	24 hours	The duration of postoperative analgesia was calculated as the time in minutes starting after the dressing of the patient in the operation room until the patient had a VAS≥3.

Trial Locations

Locations (1)

Quaid-e-Azam Medical College; 🇵🇰 Bahawalpur, Punjab, Pakistan