Pregabalin and Analgesia After Laparoscopic Cholecystectomy

Larissa University Hospital

Status: Completed

Conditions: Pain Postoperative

Treatments: Drug: placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT01321801

UHL25872/ 08/17/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Pregabalin

Active Comparator group

Description:

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

Treatment:

Drug: Pregabalin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo