Pain Control With Total Knee Replacement

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Gabapentin

• Registration Number: NCT01680549
• Lead Sponsor: Texas Tech University Health Sciences Center

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2016-11-28
• Results First Submitted QC: 2017-01-26
• Results First Posted: 2017-03-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Placebo	Gabapentin	Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days

Primary Outcome Measures

Name	Time	Method
Patient Pain Scores	3 days	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

Secondary Outcome Measures

Name	Time	Method
Narcotics Consumption	3 days	Narcotics consumption was recorded on postoperative days 0, 1, and 2.
Knee Range of Motion	3 days	Patient knee range of motion was assessed on postoperative days 0, 1 and 2.
Patient Restfulness	3 days	Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.

Trial Locations

Locations (1)

TTUHSC Orthopaedic Surgery MS 9436; 🇺🇸 Lubbock, Texas, United States