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

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

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:

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

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

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
Morphine
Gabapentin
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Central Nervous System Depressants
Narcotics
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012