Back to resultsPain Control With Total Knee Replacement (L12-078)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
• Age > 25 years old
- Primary osteoarthritis of the knee
- Must be undergoing unilateral total knee arthroplasty
- Anesthesia assesment score I, II, or III
Exclusion Criteria:
Severe joint malalignment (defined as varus/valgus angle > 20 deg)
- Use of gabapentin pre-operatively
- History of chronic pain (currently under treatment)
- History of substance abuse
- Impaired kidney function (defined as creatinine > 1.5)
- Epilepsy (currently on medication for treatment)
- Known allergy to Gabapentin
- Known history of depression or suicidal thoughts and behaviors
- Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.
Sites / Locations
- TTUHSC Orthopaedic Surgery MS 9436
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days
Outcomes
Primary Outcome Measures
Patient Pain Scores
Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.
Scale range: 0-100 Higher Values = More Pain
Secondary Outcome Measures
Narcotics Consumption
Narcotics consumption was recorded on postoperative days 0, 1, and 2.
Knee Range of Motion
Patient knee range of motion was assessed on postoperative days 0, 1 and 2.
Patient Restfulness
Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.
Full Information
NCT ID
NCT01680549
First Posted
September 4, 2012
Last Updated
January 26, 2017
Sponsor
Texas Tech University Health Sciences Center
1. Study Identification
Unique Protocol Identification Number
NCT01680549
Brief Title
Pain Control With Total Knee Replacement
Acronym
L12-078
Official Title
Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.
Detailed Description
Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Fanatrex, Gabarone, Gralise, Horizant, Neurontin
Intervention Description
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Primary Outcome Measure Information:
Title
Patient Pain Scores
Description
Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.
Scale range: 0-100 Higher Values = More Pain
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Narcotics Consumption
Description
Narcotics consumption was recorded on postoperative days 0, 1, and 2.
Time Frame
3 days
Title
Knee Range of Motion
Description
Patient knee range of motion was assessed on postoperative days 0, 1 and 2.
Time Frame
3 days
Title
Patient Restfulness
Description
Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Age > 25 years old
Primary osteoarthritis of the knee
Must be undergoing unilateral total knee arthroplasty
Anesthesia assesment score I, II, or III
Exclusion Criteria:
Severe joint malalignment (defined as varus/valgus angle > 20 deg)
Use of gabapentin pre-operatively
History of chronic pain (currently under treatment)
History of substance abuse
Impaired kidney function (defined as creatinine > 1.5)
Epilepsy (currently on medication for treatment)
Known allergy to Gabapentin
Known history of depression or suicidal thoughts and behaviors
Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George W Brindley, MD
Organizational Affiliation
TTUHSC dept. Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
TTUHSC Orthopaedic Surgery MS 9436
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pain Control With Total Knee Replacement
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