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| Sponsors and Collaborators: |
Mahidol University Siriraj Hospital |
|---|---|
| Information provided by: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT00795223 |
Purpose
Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or 0.5 % bupivacaine for single femoral nerve block
| Condition | Intervention | Phase |
|---|---|---|
|
Post Operative Pain Total Knee Replacement |
Drug: morphine and bupivacaine Drug: spinal morphine and marcaine Drug: morphine and bupivacaine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Comparative Effect of 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for Femoral Nerve Block After Total Knee Replacement |
| Estimated Enrollment: | 160 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine
|
Drug: morphine and bupivacaine
0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block
|
|
2: Active Comparator
Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine
|
Drug: spinal morphine and marcaine
0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block
|
|
3: Active Comparator
Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine
|
Drug: morphine and bupivacaine
0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block
|
|
4: Active Comparator
Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine
|
Drug: morphine and bupivacaine
0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block
|
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thitima Chinachoti, MD | sitci@mahidol.ac.th |
| Thailand, Bangkoknoi | |
| Siriraj Hospital | |
| Bangkok, Bangkoknoi, Thailand, 10700 | |
| Principal Investigator: | Thitima Chinachoti, MD | Siriraj Hospital |
More Information
| Responsible Party: | Siriraj Hospital ( Thitima Chinachoti ) |
| Study ID Numbers: | 461/2551(EC1), Grant by the siriraj Hospital |
| Study First Received: | November 20, 2008 |
| Last Updated: | November 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00795223 |
| Health Authority: | Thailand: Ethical Committee |
|
Morphine Signs and Symptoms Postoperative Complications |
Bupivacaine Pain Pain, Postoperative |
|
Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Anesthetics, Local Pharmacologic Actions Pathologic Processes |
Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid |
