Pain Control With Total Knee Replacement (L12-078)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Gabapentin

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
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gabapentin; Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.	Drug: Gabapentin; Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.; Other Names: Gralise; Neurontin; Gabarone; Fanatrex; Horizant
Placebo Comparator: Placebo; Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days	Drug: Gabapentin; Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.; Other Names: Gralise; Neurontin; Gabarone; Fanatrex; Horizant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: George W Brindley, MD, TTUHSC dept. Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (Estimated): September 7, 2012

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: L12-078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO