Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction

Phase 4

Completed

• Conditions: Postoperative Pain Management
• Interventions: Drug: Pregabalin

• Registration Number: NCT01242332
• Lead Sponsor: Prince of Songkla University

Brief Summary

To prove pregabalin's efficacy and safety in Thai patients scheduled for arthroscopic ACL reconstruction

Detailed Description

Only eligible patients with willingness to join this study are included. Eligible patients are those aged 18-65 years of either sex, American Society of Anesthesiologists (ASA) physical status I \& II, and body mass index (BMI) between 16-35. The exclusion criteria are patients who are allergic to pregabalin, with impaired hepatic and renal functions, alcohol or substance abuse, chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus) and inability to operate patient-controlled analgesia (PCA) device.

Data analysis

* Student t-test for continuous data with normal distribution

* Mann-Whitney U test for continuous data with non-normal distribution

* Chi-square test for categorical data

Study Timeline

• Status Verified: 2009-05
• Study Start: 2009-08
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Last Update Submitted: 2010-11-16
• Study First Posted: 2010-11-17
• Last Update Posted: 2010-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Eligible patients are those aged 18-65 years of either sex,
• American Society of Anesthesiologists (ASA) physical status I & II, and body mass index (BMI) between 16-35.

Exclusion Criteria

• patients who are allergic to pregabalin,
• impaired hepatic and renal functions,
• alcohol or substance abuse,
• chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus)
• inability to operate patient-controlled analgesia (PCA) device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin	Pregabalin	75 mg po 2 hrs before surgery

Primary Outcome Measures

Name	Time	Method
efficacy	August 2009 - January 2011	efficacy of postoperative pain management

Secondary Outcome Measures

Name	Time	Method
safety	August 2009 - January 2011	safety of pregabalin for postoperative pain management

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hatyai, Songkhla, Thailand