Effect of Gabapentin on Orthopedic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01546857
First received: March 1, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Degenerative Joint Disease of Hip and Knee.
Drug: Placebo
Drug: Gapabentin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Gabapentin on Postoperative Pain: a Randomized, Double Blind, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • The primary endpoint will be opioid consumption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Total opioid consumption and lowest/highest pain score in 8 hour segments.


Secondary Outcome Measures:
  • sleep scales [ Time Frame: 48 hours post operatively ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index.


Estimated Enrollment: 90
Study Start Date: March 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Placebo one dose in the evening of surgery and post op day #1.
Drug: Placebo
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546857

Contacts
Contact: Daniel J. Eloy, MD 973 972-5254 eloyje@njms.rutgers.edu
Contact: Catherine Schoenberg, BSN 973 972-7477 shoenbce@njms.rutgers.edu

Locations
United States, New Jersey
University Hospital Recruiting
Newark, New Jersey, United States, 07101
Contact: Daniel Eloy, MD    973-972-5254    eloyje@njms.rutgers.edu   
Contact: Catherine Schoenberg, BSN    973 972-7477    shoenbce@njms.rutgers.edu   
Principal Investigator: Daniel Eloy, MD         
Sub-Investigator: Steven Shulman, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Anesthesia, J. Daniel Eloy, MD Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01546857     History of Changes
Other Study ID Numbers: 2011001012
Study First Received: March 1, 2012
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
orthopedic pain

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Osteoarthritis, Hip
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
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 July 24, 2014