Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study - Full Text View

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00889148

Purpose

Total knee and hip arthroplasty are 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 Joint Replacement	Drug: Gabapentin Other: Placebo

Drug Information available for: Gabapentin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Knee or Hip Arthroplasty

Further study details as provided by McMaster University:

Primary Outcome Measures:

To determine if gabapentin given preoperatively and continued for three days postoperatively will reduce postoperative morphine consumption [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if multiple doses of gabapentin decrease morphine-related side effect, improve quality of pain treatment, or patient satisfaction after total knee or hip replacement surgery. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Gabapentin: Experimental 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
Placebo: Placebo Comparator	Other: Placebo Half the patients will be randomized to placebo

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. The randomization will be stratified by type of knee arthroplasty. Ninety patients undergoing primary total knee arthroplasty and 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 knee arthroplasty or 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 knee arthroplasty or bilateral total hip arthroplasty
revision total knee or 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889148

Contacts

Contact: Manyat Nantha-Aree, MD

905-521-2100 ext 44890

nantham@mcmaster.ca

Locations

Canada, Ontario
Hamilton Health Sciences	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Sub-Investigator: James Paul, MD

Sponsors and Collaborators

Hamilton Health Sciences

Investigators

Principal Investigator:

Manyat Nantha-Aree, MD

Hamilton Health Sciences

More Information

No publications provided

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

Keywords provided by McMaster University:

hip
knee
arthroplasty
postoperative pain
gabapentin

Study placed in the following topic categories:

Excitatory Amino Acids
Morphine
Neurotransmitter Agents
Tranquilizing Agents
Gabapentin
Psychotropic Drugs
Central Nervous System Depressants
Calcium Channel Blockers
Pain
Cardiovascular Agents

Antimanic Agents
Signs and Symptoms
Calcium, Dietary
Postoperative Complications
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Pain, Postoperative
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Pain
Membrane Transport Modulators
Signs and Symptoms
Pathologic Processes
Sensory System Agents

Therapeutic Uses
Analgesics
Pain, Postoperative
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Postoperative Complications
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009