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Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment

This study has been completed.
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01307202
First received: February 28, 2011
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

Total knee 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 int hese patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reducted pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated in total joint arthroplasty patients.


Condition Intervention
Post Operative Pain
Total Knee Replacement
Drug: Gabapentin
Drug: 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 Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Amount of morphine consumption [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness


Enrollment: 101
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
Gabapentin 600 mg will be given per oral two hours preoperatively and 200 mg three times daily after surgery (600 mg/day).
Drug: Gabapentin
600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days
Other Name: Neurontin
Placebo Comparator: Placebo
Placebo will match the the gabapentin pill and will be given orally.
Drug: Placebo
Placebo will match the the gabapentin pill and will be given orally.
Other Name: Sugar pill

Detailed Description:

The study was submitted to Health Canada and received the letter of no objection. A randomized, double-blind, placebo-controlled study. The randomization scheme will be prepared and will be done by the pharmacy department at McMaster University. Ninety patients undergoing primary knee 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 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 knee arthroplasty
  • use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist

Exclusion Criteria:

  • bilateral total knee arthroplasty
  • revision knee arthroplasty
  • underlying disease 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
  • participant 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: NCT01307202

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

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01307202     History of Changes
Other Study ID Numbers: 07-215-TKR
Study First Received: February 28, 2011
Last Updated: November 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
knee
arthroplasty
postoperative pain
gabapentin

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014