Pain Control With Total Knee Replacement

Postoperative Pain Clinical Trial

— L12-078  

Official title:

Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680549
• Other study ID #: L12-078
• Status: Completed
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: February 2016

Study information

• Verified date: January 2024
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
United States	TTUHSC Orthopaedic Surgery MS 9436	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Pain Scores	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	3 days
Secondary	Narcotics Consumption	Narcotics consumption was recorded on postoperative days 0, 1, and 2.	3 days
Secondary	Knee Range of Motion	Patient knee range of motion was assessed on postoperative days 0, 1 and 2.	3 days
Secondary	Patient Restfulness	Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.	3 days