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Pain Control With Total Knee Replacement (L12-078)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
GBrindley, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01680549
First received: September 4, 2012
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  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.


Condition Intervention Phase
Postoperative Pain
 Drug: Gabapentin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Patients 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


Secondary Outcome Measures:
  • Functional 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


Estimated Enrollment: 72
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Fanatrex
  • Gabarone
  • Gralise
  • Horizant
  • Neurontin
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:
  • Fanatrex
  • Gabarone
  • Gralise
  • Horizant
  • Neurontin

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680549

Locations
United States, Texas
TTUHSC Orthopaedic Surgery MS 9436
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: George W Brindley, MD TTUHSC dept. Orthopaedic Surgery
  More Information

No publications provided

Responsible Party: GBrindley, Chairman TTUHSC Orthopaedic Surgery, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01680549     History of Changes
Other Study ID Numbers: L12-078
Study First Received: September 4, 2012
Last Updated: September 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
 Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 23, 2013