Back to resultsPerioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
Primary Purpose
Postoperative Pain Management
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain Management focused on measuring perioperative, pregabalin, arthroscopic anterior cruciate ligament reconstruction, postoperative pain management
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
placebo
Pregabalin
Arm Description
po 2 hrs before surgery
75 mg po 2 hrs before surgery
Outcomes
Primary Outcome Measures
efficacy
efficacy of postoperative pain management
Secondary Outcome Measures
safety
safety of pregabalin for postoperative pain management
Full Information
NCT ID
NCT01242332
First Posted
November 16, 2010
Last Updated
November 16, 2010
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01242332
Brief Title
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
Official Title
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: Does it Help to Relieve Postoperative Pain?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Management
Keywords
perioperative, pregabalin, arthroscopic anterior cruciate ligament reconstruction, postoperative pain management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
No Intervention
Arm Description
po 2 hrs before surgery
Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
75 mg po 2 hrs before surgery
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
75 mg po 2 hrs before surgery
Primary Outcome Measure Information:
Title
efficacy
Description
efficacy of postoperative pain management
Time Frame
August 2009 - January 2011
Secondary Outcome Measure Information:
Title
safety
Description
safety of pregabalin for postoperative pain management
Time Frame
August 2009 - January 2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasikaan Nimmaanrat, MD, MMed
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Prince of Songkla University
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
19641054
Citation
Chang SH, Lee HW, Kim HK, Kim SH, Kim DK. An evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after laparoscopic cholecystectomy. Anesth Analg. 2009 Oct;109(4):1284-6. doi: 10.1213/ane.0b013e3181b4874d. Epub 2009 Jul 29.
Results Reference
result
Learn more about this trial
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
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