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.
ConditionPostoperative Pain
InterventionDrug: Gabapentin
PhasePhase 4
SponsorTexas Tech University Health Sciences Center
Responsible PartyTexas Tech University Health Sciences Center
ClinicalTrials.gov IdentifierNCT01680549
First ReceivedSeptember 4, 2012
Last UpdatedFebruary 26, 2014
Last verifiedFebruary 2014

Tracking Information[ + expand ][ + ]

First Received DateSeptember 4, 2012
Last Updated DateFebruary 26, 2014
Start DateSeptember 2012
Estimated Primary Completion DateSeptember 2014
Current Primary Outcome MeasuresPatients 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 MeasuresFunctional 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 TitlePain Control With Total Knee Replacement
Official TitlePain 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 TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionPostoperative Pain
InterventionDrug: Gabapentin
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Other Names:
  • Fanatrex
  • Gabarone
  • Gralise
  • Horizant
  • Neurontin
Study Arm (s)
  • Active Comparator: Gabapentin
    Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
  • Placebo Comparator: Placebo
    Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days

Recruitment Information[ + expand ][ + ]

Recruitment StatusEnrolling by invitation
Estimated Enrollment72
Estimated Completion DateSeptember 2014
Estimated Primary Completion DateSeptember 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.
GenderBoth
Ages25 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01680549
Other Study ID NumbersL12-078
Has Data Monitoring CommitteeNo
Information Provided ByTexas Tech University Health Sciences Center
Study SponsorTexas Tech University Health Sciences Center
CollaboratorsNot Provided
Investigators Principal Investigator: George W Brindley, MD TTUHSC dept. Orthopaedic Surgery
Verification DateFebruary 2014

Locations[ + expand ][ + ]

TTUHSC Orthopaedic Surgery MS 9436
Lubbock, Texas, United States, 79430