Effect of Gabapentin on Orthopedic Pain
This study is currently recruiting participants.
Verified January 2013 by University of Medicine and Dentistry New Jersey
Sponsor:
University of Medicine and Dentistry New Jersey
Information provided by (Responsible Party):
Anesthesia, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01546857
First received: March 1, 2012
Last updated: January 14, 2013
Last verified: January 2013
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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 University of Medicine and Dentistry 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: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546857
Contacts
| Contact: Daniel J. Eloy, MD | 973 972-5254 | eloyje@umdnj.edu |
| Contact: Catherine Schoenberg, BSN | 973 972-7477 | shoenbce@umdnj.edu |
Locations
| United States, New Jersey | |
| University Hospital | Recruiting |
| Newark, New Jersey, United States, 07101 | |
| Contact: Daniel Eloy, MD 973-972-5254 eloyje@umdnj.edu | |
| Contact: Catherine Schoenberg, BSN 973 972-7477 shoenbce@umdnj.edu | |
| Principal Investigator: Daniel Eloy, MD | |
| Sub-Investigator: Steven Shulman, MD | |
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
More Information
No publications provided
| Responsible Party: | Anesthesia, J. Daniel Eloy, MD Assistant Professor, University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT01546857 History of Changes |
| Other Study ID Numbers: | 2011001012 |
| Study First Received: | March 1, 2012 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry 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 June 13, 2013