Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT01242332
Status:
COMPLETED
Last Update Posted:
2010-11-17
First Post:
2010-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
Sponsor:
Prince of Songkla University
Organization:
Study Overview
Official Title:
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: Does it Help to Relieve Postoperative Pain?
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: