Phase 4
N=50
Pain Control With Total Knee Replacement
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01680549 ↗Enrolled (actual)
50
Serious AEs
8.1%
Results posted
Mar 2017
Primary outcome: Primary: Patient Pain Scores — 33.6; 40.0; 34.9; 46.3 units on a scale- VAS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gabapentin (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Texas Tech University Health Sciences Center
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Pain Scores |
33.6; 40.0; 34.9; 46.3; 38.0; 39.6 | — |
| SECONDARY Narcotics Consumption |
4.16; 7.40; 11.53; 25.02; 11.61; 21.62 | — |
| SECONDARY Knee Range of Motion |
53.12; 57.85; 66.81; 62.74; 67.47; 65.94 | — |
| SECONDARY Patient Restfulness |
35.3; 55.0; 52.9; 75.0; 58.5; 65.0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01680549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.