Effect of Gabapentin on Orthopedic Pain

NCT01546857 | Terminated Phase 4 Results

• 1 other identifier: 2011001012
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Arthritis and Postoperative Pain

Keywords

orthopedic pain

Outcome Measures

Primary Outcomes (2)

• Quality of Sleep.

  A questionnaire was administered asking participants about the quality of their sleep on the night of surgery asked on postoperative day 1, and on the first postoperative night ( POD 2) . Scored on a scale of zero to 3. Zero meaning poor postoperative sleep and 3 indicating better postoperative sleep.

  Night of surgery (POD 1) and Postoperative Day 2.(POD 2)

• Opioid Consumption

  Patient Controlled Analgesia use over 48 hours reported in Morphine equivalent dosage.

  48 hours post operatively

Secondary Outcomes (2)

• Visual Analogue Scale for Pain

  48 hours post operatively

• Number of Participants Reaching Rehab Goals.

  Duration of hospital stay up to 48 hours

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo one dose in the evening of surgery and post op day #1.

Drug: Placebo

Gabapentin

ACTIVE COMPARATOR

Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively

Drug: Gapabentin

Interventions

Placebo DRUG

Normal Saline

placebo

Gapabentin DRUG

400mg orally at 9pm day of surgery and the first evening post operatively.

Also known as: Neurontin

Gabapentin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

Related Publications (1)

• Eloy JD, Anthony C, Amin S, Caparo M, Reilly MC, Shulman S. Gabapentin Does Not Appear to Improve Postoperative Pain and Sleep Patterns in Patients Who Concomitantly Receive Regional Anesthesia for Lower Extremity Orthopedic Surgery: A Randomized Control Trial. Pain Res Manag. 2017;2017:2310382. doi: 10.1155/2017/2310382. Epub 2017 Feb 27.

  PMID: 28348503 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis; Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Jean Daniel Eloy
• Organization: Rutgers-New Jersey Medical School

eloyje@njms.rutgers.edu

9739721470

Study Officials

• J. Daniel Eloy, MD

  Rutgers/SUNJ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: J. Daniel Eloy, MD Assistant Professor

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 19, 2021
• Results First Posted: January 19, 2021

Record last verified: 2021-01

Locations

US (1)