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

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

Detailed Description
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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

Official Title
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Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: Does it Help to Relieve Postoperative Pain?

Conditions
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Postoperative Pain Management

Intervention / Treatment
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* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: placebo<br>po 2 hrs before surgery | |
| Experimental: Pregabalin<br>75 mg po 2 hrs before surgery | Drug: Pregabalin<br>* 75 mg po 2 hrs before surgery<br>* Other names: Lyrica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy | efficacy of postoperative pain management | August 2009 - January 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | safety of pregabalin for postoperative pain management | August 2009 - January 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative, pregabalin, arthroscopic anterior cruciate ligament reconstruction, postoperative pain management