Pain Control With Total Knee Replacement (L12-078)

Texas Tech University Health Sciences Center

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT01680549

L12-078

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 25 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Gabapentin

Active Comparator group

Description:

Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Description:

Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days

Treatment:

Drug: Gabapentin