Pregabalin and Analgesia After Laparoscopic Cholecystectomy

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy.

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Detailed Description

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Acute pain frequently occurs during the postoperative period.Not treated acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of pregabalin, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that pregabalin may have a role in the post operative pain management, as an adjunct. Pregabalin is an anticonvulsant and anxiolytic drug, which have a more favorable pharmacokinetic profile from its predecessor gabapentin.

Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.

Conditions

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Pain Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pregabalin

Preoperative administration of pregabalin 600mg to patients undergo laparoscopic cholecystectomy.Patients receive oral Pregabalin 300 mg the night before the surgery, and another one dose of 300 mg 1 hour prior to surgery

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

Preoperative administration of pregabalin 600mg

Placebo

Preoperative administration of placebo to patients undergo laparoscopic cholecystectomy.Patients receive oral Placebo the night before the surgery, and another one dose 1 hour prior to surgery.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Preoperative administration of a matching placebo

Interventions

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Pregabalin

Preoperative administration of pregabalin 600mg

Intervention Type DRUG

placebo

Preoperative administration of a matching placebo

Intervention Type DRUG

Other Intervention Names

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Lyrica

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I-II

Exclusion Criteria

* Renal or hepatic insufficiency
* Alcohol or drugs abuse
* History of chronic pain or daily intake of analgesics
* Uncontrolled medical disease (hypertension, diabetes) and cardiovascular problems. Psychiatric disorders
* Inability of patients to use PCA pump
* History of intake of non-steroidal anti-inflammatory drugs the last 24 hours before surgery,use of drainage after the surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Chamaidi Sarakatsianou

RN,MSc

Responsibility Role PRINCIPAL_INVESTIGATOR