Pain Control With Total Knee Replacement
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Postoperative Pain |
Intervention | Drug: Gabapentin |
Phase | Phase 4 |
Sponsor | Texas Tech University Health Sciences Center |
Responsible Party | Texas Tech University Health Sciences Center |
ClinicalTrials.gov Identifier | NCT01680549 |
First Received | September 4, 2012 |
Last Updated | February 26, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | September 4, 2012 |
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Last Updated Date | February 26, 2014 |
Start Date | September 2012 |
Estimated Primary Completion Date | September 2014 |
Current Primary Outcome Measures | Patients pain assessed by the Visual Analog Scale (VAS) [Time Frame: 2 weeks] [Designated as safety issue: No]Post-operative pain assessed by the VAS daily for 2 weeks |
Current Secondary Outcome Measures | Functional Outcome [Time Frame: 2 weeks] [Designated as safety issue: No]Patients functional outcome will be assessed by a daily home diary, and physical therapy documents |
Descriptive Information[ + expand ][ + ]
Brief Title | Pain Control With Total Knee Replacement |
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Official Title | Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial. |
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. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Postoperative Pain |
Intervention | Drug: Gabapentin Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Enrolling by invitation |
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Estimated Enrollment | 72 |
Estimated Completion Date | September 2014 |
Estimated Primary Completion Date | September 2014 |
Eligibility Criteria | Inclusion Criteria: - • Age > 25 years old - Primary osteoarthritis of the knee - Must be undergoing unilateral total knee arthroplasty - ASA 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. |
Gender | Both |
Ages | 25 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01680549 |
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Other Study ID Numbers | L12-078 |
Has Data Monitoring Committee | No |
Information Provided By | Texas Tech University Health Sciences Center |
Study Sponsor | Texas Tech University Health Sciences Center |
Collaborators | Not Provided |
Investigators | Principal Investigator: George W Brindley, MD TTUHSC dept. Orthopaedic Surgery |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
TTUHSC Orthopaedic Surgery MS 9436 | Lubbock, Texas, United States, 79430 |
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