- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01242332
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: Does it Help to Relieve Postoperative Pain?
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Songkhla
-
Hatyai, Songkhla, Thailand, 90110
- Faculty of Medicine, Prince of Songkla University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: placebo
po 2 hrs before surgery
|
|
Experimental: Pregabalin
75 mg po 2 hrs before surgery
|
75 mg po 2 hrs before surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
efficacy
Time Frame: August 2009 - January 2011
|
efficacy of postoperative pain management
|
August 2009 - January 2011
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety
Time Frame: August 2009 - January 2011
|
safety of pregabalin for postoperative pain management
|
August 2009 - January 2011
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sasikaan Nimmaanrat, MD, MMed, Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- EC 52 -234-08-1-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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