Pain Control With Total Knee Replacement
L12-078
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 postoperative-pain
Started Sep 2012
Longer than P75 for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
March 17, 2017
CompletedJanuary 31, 2024
January 1, 2024
3.4 years
September 4, 2012
November 28, 2016
January 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
3 days
Secondary Outcomes (3)
Narcotics Consumption
3 days
Knee Range of Motion
3 days
Patient Restfulness
3 days
Study Arms (2)
Gabapentin
ACTIVE COMPARATORGabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Placebo
PLACEBO COMPARATORPlacebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days
Interventions
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Eligibility Criteria
You may qualify if:
- Age \> 25 years old
- Primary osteoarthritis of the knee
- Must be undergoing unilateral total knee arthroplasty
- Anesthesia assesment score I, II, or III
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TTUHSC Orthopaedic Surgery MS 9436
Lubbock, Texas, 79430, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nancy Swinford
- Organization
- Texas Tech University Health Sciences Center
Study Officials
- PRINCIPAL INVESTIGATOR
George W Brindley, MD
TTUHSC dept. Orthopaedic Surgery
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2012
First Posted
September 7, 2012
Study Start
September 1, 2012
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
January 31, 2024
Results First Posted
March 17, 2017
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share