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Clinical Trials/NCT01321801
NCT01321801
Completed
N/A

Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy

Larissa University Hospital1 site in 1 country50 target enrollmentNovember 2009

Overview

Phase
N/A
Intervention
Pregabalin
Conditions
Pain Postoperative
Sponsor
Larissa University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Postoperative pain
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
December 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Larissa University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Chamaidi Sarakatsianou

RN,MSc

Larissa University Hospital

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Pregabalin

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.

Intervention: placebo

Outcomes

Primary Outcomes

Postoperative pain

Time Frame: Every 8 hours

VAS = visual analoque scale 0-10 mm (0=no pain to 10= worst imaginable pain).Measured on the arrival of the patient to the recovery room(0 hrs), one hour later, and then every eight hours until the completion of 24 hours after operation.

Secondary Outcomes

  • Side- effects(0,1, 8, 16 & 24 hours)
  • Postoperative opioid consumption(0,1, 8, 16 & 24 hour)

Study Sites (1)

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