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Clinical Trial Summary

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


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01242332
Study type Interventional
Source Prince of Songkla University
Contact
Status Completed
Phase Phase 4
Start date August 2009
Completion date October 2010

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