Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine

NCT06560892 | Completed

• 1 other identifier: DRQAZIANEESBVH
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

LAPAROSCOPIC CHOLECYSTECTOMY

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  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.

  24 hours

Study Arms (2)

Bupivacaine group

EXPERIMENTAL

Patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline

Drug: Bupivacaine injection

Bupivacaine + Dexmedetomidine group

EXPERIMENTAL

Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml

Drug: Bupivacaine injection; Drug: Dexmedetomidine injection

Interventions

Bupivacaine injection DRUG

patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline.

Also known as: Local anesthetic

Bupivacaine + Dexmedetomidine group; Bupivacaine group

Dexmedetomidine injection DRUG

Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml.

Also known as: Local anesthetic

Bupivacaine + Dexmedetomidine group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead
• Bahawal Victoria Hospital: collaborator

Study Sites (1)

Quaid-e-Azam Medical College

Bahawalpur, Punjab Province, 06318, Pakistan

Location

MeSH Terms

Interventions

Bupivacaine; Anesthetics, Local; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Qazi Anees, FCPS

  Bahawal Victoria Hospital

  PRINCIPAL INVESTIGATOR

• Syed Shakeel Ahmed, FCPS

  Shahida Islam Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)