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NCT Number: NCT06560892

Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine

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.

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Key information

Conditions

Laparoscopic Cholecystectomy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quaid-e-Azam Medical College

Bahawalpur, Punjab Province, 06318, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)

Treatment and study plan

Bupivacaine Injection

Drug

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

Other names: Local anesthetic

Dexmedetomidine Injection

Drug

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

Other names: Local anesthetic

Primary outcomes

  1. Duration of analgesia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

RESnTEC, Institute of Research

Other

Collaborators

  • Bahawal Victoria Hospital

Registry information

Official study title

Comparison Between Mean Duration of Post-operative Analgesia of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine Following Laparoscopic Cholecystectomy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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