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

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00889148
First received: April 27, 2009
Last updated: February 28, 2011
Last verified: April 2009
  Purpose

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 Intervention
Postoperative Pain
Total Hip Replacement
Drug: Gabapentin
Other: Placebo

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: Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Amount of morphine consumption [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness

  • Pain scores [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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


Enrollment: 103
Study Start Date: October 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00889148

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

No publications provided

Responsible Party: Dr. Manyat Nantha-Aree, MD, FRCAT, Hamilton Heath Sciences
ClinicalTrials.gov Identifier: NCT00889148     History of Changes
Other Study ID Numbers: 07-215-THR
Study First Received: April 27, 2009
Last Updated: February 28, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
hip
arthroplasty
postoperative pain
gabapentin

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
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 August 28, 2014