Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-06-30

Brief Summary

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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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Detailed Description

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Conditions

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LAPAROSCOPIC CHOLECYSTECTOMY

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Bupivacaine group

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

Group Type EXPERIMENTAL

Bupivacaine injection

Intervention Type DRUG

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

Bupivacaine + Dexmedetomidine group

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

Group Type EXPERIMENTAL

Bupivacaine injection

Intervention Type DRUG

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

Dexmedetomidine injection

Intervention Type DRUG

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

Interventions

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Bupivacaine injection

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

Intervention Type DRUG

Dexmedetomidine injection

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

Intervention Type DRUG

Other Intervention Names

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Local anesthetic Local anesthetic

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No