Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study (MOBILE)

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: NCT00889148
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : March 2, 2011
Information provided by:
McMaster University

Brief Summary:
Total hip arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain in these patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reduced postoperative pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated for total joint arthroplasty patients.

Condition or disease Intervention/treatment Phase
Postoperative Pain Total Hip Replacement Drug: Gabapentin Other: Placebo Not Applicable

Detailed Description:
The study was submitted to Health Canada and has received the letter of no objection. A randomized, double-blind, placebo-controlled trial will be conducted. The randomization scheme will be prepared and done by the pharmacy department at McMaster University. Ninety patients undergoing primary hip arthroplasty will be recruited from the preoperative clinic. Forty-five patients in each population will be allocated to a gabapentin group and the other forty-five patients will be allocated to a placebo group.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty
Study Start Date : October 2007
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gabapentin
600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days.
Drug: Gabapentin
600mg gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days
Other Name: Neurontin
Placebo Comparator: Placebo Other: Placebo
Half the patients will be randomized to placebo
Other Name: Sugar pill

Primary Outcome Measures :
  1. Amount of morphine consumption [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: Two years ]
    Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness

  2. Pain scores [ Time Frame: Two years ]
    Pain score at rest in PACU, POD1, POD2, POD3 Pain score upon passive movement in PACU, POD1, POD2, POD3 Pain score with weighbearing on POD1, POD2, POD3

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • participants aged 19-90
  • elective single joint, primary total hip arthroplasty
  • use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist

Exclusion Criteria:

  • bilateral total hip arthroplasty
  • revision hip arthroplasty
  • underlying diseases of epilepsy, seizure, or chronic pain syndrome
  • active gastrointestinal bleeding within the last 6 months
  • history of non-steroidal anti-inflammatory drug (NSAID) induced asthma
  • known or suspected history of drug or alcohol abuse
  • participate currently takes gabapentin or pregabalin for any reason
  • participant currently takes pain medication that is more potency than codeine or oxycodone (morphine, hydromorphone, meperidine, methadone, fentanyl, including any long acting narcotics)
  • known allergy to study medications: gabapentin, morphine, NSAID, acetaminophen
  • unable to tolerate morphine
  • liver impairments
  • kidney impairment or calculated creatinine clearance by Cockcroft-Gault formula is <=60ml/min
  • pregnancy or breast-feeding
  • participant currently receives associated worker's compensation benefits (WSIB)
  • participant unable or unwilling to give written or informed consent
  • unable to use PCA

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): NCT00889148

Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Manyat Nantha-Aree, MD Hamilton Health Sciences Corporation

Responsible Party: Dr. Manyat Nantha-Aree, MD, FRCAT, Hamilton Heath Sciences Identifier: NCT00889148     History of Changes
Other Study ID Numbers: 07-215-THR
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: April 2009

Keywords provided by McMaster University:
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
gamma-Aminobutyric Acid
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents