Pregabalin and Analgesia After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Pain Postoperative
• Interventions: Drug: Pregabalin; Drug: placebo

• Registration Number: NCT01321801
• Lead Sponsor: Larissa University Hospital

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.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin	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
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	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 Outcome Measures

Name	Time	Method
Side- effects	0,1, 8, 16 & 24 hours	To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, dizziness, blurred vision, lack of concentration, shoulder pain, sedation, and respiratory depression.
Postoperative opioid consumption	0,1, 8, 16 & 24 hour	The total dose of morphine was calculated as mg and included opioids administered by PCA pump.On arrival in the PACU patients received morphine via PCA pump.Postoperative morphine requirements were assessed 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.

Trial Locations

Locations (1)

University Hospital of Larissa; 🇬🇷 Larissa, Greece