Back to resultsDoes Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
Primary Purpose
Anterior Cruciate Ligament (ACL) Reconstruction
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pregabalin
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Anterior Cruciate Ligament (ACL) Reconstruction
Eligibility Criteria
Inclusion Criteria:
- age between 20-65 years
- physical condition type I or II in ASA (American Society of Anesthesiology)
Exclusion Criteria:
- patients of ASA classification 3 or more
- with a history of cardiovascular or respiratory disease
- dizziness or frequent headache
- active alcohol or drug usage,
- intake of any analgesics daily or 48 hours before surgery
- impaired renal and/or hepatic function
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
placebo group
Arm Description
Outcomes
Primary Outcome Measures
Postoperative pain scores
Visual analog scale (VAS) score = 0-100 mm
Postoperative pain scores
Visual analog scale (VAS) score = 0-100 mm
Postoperative pain scores
Visual analog scale (VAS) score = 0-100 mm
Postoperative pain scores
Visual analog scale (VAS) score = 0-100 mm
Secondary Outcome Measures
Opioid consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03211728
Brief Title
Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
Official Title
Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
February 8, 2019 (Actual)
Study Completion Date
February 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2 groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same points.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament (ACL) Reconstruction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Candidate for arthroscopic ACL reconstruction are divided into two groups of pregabalin and placebo with 48 patients in each group. The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose and a placebo is administered in control group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
The placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose.
Primary Outcome Measure Information:
Title
Postoperative pain scores
Description
Visual analog scale (VAS) score = 0-100 mm
Time Frame
12 hours after surgery
Title
Postoperative pain scores
Description
Visual analog scale (VAS) score = 0-100 mm
Time Frame
24 hours after surgery
Title
Postoperative pain scores
Description
Visual analog scale (VAS) score = 0-100 mm
Time Frame
36 hours after surgery
Title
Postoperative pain scores
Description
Visual analog scale (VAS) score = 0-100 mm
Time Frame
2 weeks after surgery
Secondary Outcome Measure Information:
Title
Opioid consumption
Time Frame
the first 48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 20-65 years
physical condition type I or II in ASA (American Society of Anesthesiology)
Exclusion Criteria:
patients of ASA classification 3 or more
with a history of cardiovascular or respiratory disease
dizziness or frequent headache
active alcohol or drug usage,
intake of any analgesics daily or 48 hours before surgery
impaired renal and/or hepatic function
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
We'll reach out to this number within 24 hrs