Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment
Overview[ - collapse ][ - ]
| 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 | Post Operative Pain Total Knee Replacement |
| Intervention | Drug: Gabapentin Drug: Placebo |
| Phase | N/A |
| Sponsor | McMaster University |
| Responsible Party | McMaster University |
| ClinicalTrials.gov Identifier | NCT01307202 |
| First Received | February 28, 2011 |
| Last Updated | March 1, 2011 |
| Last verified | April 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 28, 2011 |
|---|---|
| Last Updated Date | March 1, 2011 |
| Start Date | October 2007 |
| Estimated Primary Completion Date | February 2011 |
| Current Primary Outcome Measures | Amount of morphine consumption [Time Frame: 2 years] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Side effects [Time Frame: 2 years] [Designated as safety issue: No]Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness |
Descriptive Information[ + expand ][ + ]
| Brief Title | Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment |
|---|---|
| Official Title | Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Total Knee Arthroplasty |
| Brief Summary | 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. |
| 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Gabapentin 600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days Other Names: NeurontinDrug: Placebo Other Names: Sugar pill |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 101 |
| Estimated Completion Date | February 2011 |
| Estimated Primary Completion Date | February 2011 |
| Eligibility 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 |
| Gender | Both |
| Ages | 19 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01307202 |
|---|---|
| Other Study ID Numbers | 07-215-TKR |
| Has Data Monitoring Committee | No |
| Information Provided By | McMaster University |
| Study Sponsor | McMaster University |
| Collaborators | Hamilton Health Sciences Corporation |
| Investigators | Principal Investigator: Manyat Nantha-Aree, MD Hamilton Health Sciences Corporation |
| Verification Date | April 2009 |
Locations[ + expand ][ + ]
| Hamilton Health Sciences | Hamilton, Ontario, Canada, L8N 3Z5 |
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