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Trial record 1 of 1 for:    NCT01546857
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Effect of Gabapentin on Orthopedic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01546857
Recruitment Status : Terminated (No longer able to recruit subjects due to unavailability of orthopedic surgeon.)
First Posted : March 7, 2012
Last Update Posted : September 28, 2016
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Brief Summary:
This study is being done to determine if a drug called gabapentin helps in the postoperative management of patients undergoing hip and knee operations. The investigators wish to determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a patient's pain and improve sleep, the patient will be better able to participate in their physical therapy. Gabapentin has already been shown to lessen postoperative pain when given before surgery. In healthy patients, it has also been shown to improve certain aspects of sleep. We hope to identify the effect of the drug, when given after surgery, on patients' pain and sleep.

Condition or disease Intervention/treatment Phase
Degenerative Joint Disease of Hip and Knee. Drug: Placebo Drug: Gapabentin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Gabapentin on Postoperative Pain: a Randomized, Double Blind, Placebo Controlled Trial
Study Start Date : March 2012
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: placebo
Placebo one dose in the evening of surgery and post op day #1.
Drug: Placebo

Active Comparator: Gabapentin
Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively
Drug: Gapabentin
400mg orally at 9pm day of surgery and the first evening post operatively.
Other Name: Neurontin

Primary Outcome Measures :
  1. The primary endpoint will be opioid consumption [ Time Frame: 48 hours ]
    Total opioid consumption and lowest/highest pain score in 8 hour segments.

Secondary Outcome Measures :
  1. sleep scales [ Time Frame: 48 hours post operatively ]
    Pittsburgh Sleep Quality Index.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Undergoing a hip arthroplasty, total knee arthroplasty, hip fracture repair American Society of Anesthesiologist rating I-III as determined by your anesthesiologist

Exclusion Criteria:

  • Pregnancy and breast feeding

    • An allergy to any of the drugs to be used in the study (midazolam, Celecoxib, gabapentin, hydromorphone, bupivacaine)
    • History of a sleep disorder (Obstructive sleep apnea or daytime somnolence)
    • History of taking chronic narcotic pain medications or gabapentin
    • History of rheumatoid arthritis, a psychiatric disorder, or diabetes with impaired renal function
    • History of alcohol or illicit drug abuse.
    • History of a kidney or liver problem.
    • Inability or unwilling to use patient-controlled analgesia.
    • Unable to meet the criteria for removal of the endotracheal tube in the Operating Room
    • History of asthma, hives or an allergic type reaction following an aspirin or other NSAIDS drug such as Ibuprofen.
    • History of stroke or heart attack or thrombotic event within the past 3 months
    • Lactose intolerance
    • History of cardiac surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01546857

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United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
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Principal Investigator: J. Daniel Eloy, MD Rutgers/SUNJ
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Rutgers, The State University of New Jersey Identifier: NCT01546857    
Other Study ID Numbers: 2011001012
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Rutgers, The State University of New Jersey:
orthopedic pain
Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis, Hip
Musculoskeletal Diseases
Rheumatic Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents