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| Sponsor: | University College Hospital Galway |
|---|---|
| Information provided by: | University College Hospital Galway |
| ClinicalTrials.gov Identifier: | NCT00695045 |
Purpose
This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.
| Condition | Intervention |
|---|---|
|
Pain, Postoperative Arthroplasty, Replacement, Knee |
Drug: intra thecal morphine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty |
| Enrollment: | 60 |
| Study Start Date: | July 2003 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
patients in this group got 100mcg of intrathecal morphine.
|
Drug: intra thecal morphine
100 mcg intrathecal morphine given once .
|
|
2: Experimental
patients in this group got 200 mcg intrathecal morphine
|
Drug: intra thecal morphine
200 mcg intrathecal morphine given once
|
|
3: Experimental
patients in this group given 300 mcg intrathecal morphine.
|
Drug: intra thecal morphine
300 mcg intrathecal morphine given once
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Principal Investigator: | Patrick D Hassett, MD | Department of Anaesthesia, UCHG |
| Study Chair: | John Laffey, MD | Department of Anaesthesia,UCHG |
| Study Director: | Brian Kinirons, MD | Dept of Anaesthesia , UCHG |
More Information
| Responsible Party: | Department of Anaesthesia , University College Hospital Galway ( Dr Patrick Hassett ) |
| Study ID Numbers: | 0001 |
| Study First Received: | June 9, 2008 |
| Last Updated: | June 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00695045 History of Changes |
| Health Authority: | Ireland: Ministry of Health |
|
Pain, Postoperative Arthroplasty, Replacement, Knee Morphine Injections, Intrathecal |
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Morphine Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pain Pharmacologic Actions Signs and Symptoms Pathologic Processes |
Postoperative Complications Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Pain, Postoperative Analgesics, Opioid |