Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment
This study has been completed.
Sponsor:
McMaster University
Collaborator:
Hamilton Health Sciences Corporation
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01307202
First received: February 28, 2011
Last updated: March 1, 2011
Last verified: April 2009
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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 |
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 |
Drug: Placebo
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
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
| Responsible Party: | Dr. Manyat Nantha-Aree, MD, FRCAT, Hamilton Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01307202 History of Changes |
| Other Study ID Numbers: | 07-215-TKR |
| Study First Received: | February 28, 2011 |
| Last Updated: | March 1, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McMaster University:
|
knee 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 May 23, 2013