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Sponsored by: |
Rambam Health Care Campus |
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Information provided by: | Rambam Health Care Campus |
ClinicalTrials.gov Identifier: | NCT00270322 |
The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.
Condition | Intervention | Phase |
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Pain, Postoperative Osteoarthritis |
Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml Drug: Morphine sulphate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine |
Estimated Enrollment: | 80 |
Study Start Date: | January 2006 |
Study Completion Date: | March 2007 |
Total knee replacement (TKR) is known to be one of the most painful surgical procedures. Many treatments have been used post TKR: IV opioids, epidural infusions, peripheral nerve blocks. No one method has been recognised as the best one.
In this study we will compare two well established methods of pain treatment:
The study design is double blind.
Patients will have a combined spinal-epidural anesthesia for the operation and then will be connected to 2 different pumps, one to the epidural catheter and one to the intravenous catheter, for the first 24 hours post-operatively.
Pain scores, total analgesic medications other than study medications, adverse reactions to study medications, complications and patient satisfaction will be followed by blinded observers and compared between groups.
Ages Eligible for Study: | 55 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | TKR-1.CTIL |
Study First Received: | December 23, 2005 |
Last Updated: | April 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00270322 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
total knee replacement orthopedic surgery post operative analgesia continuous epidural patients controlled analgesia morphine |
combined spinal epidural anesthesia anesthesia analgesia epidural marcaine epidural fentanyl pain |
Morphine Signs and Symptoms Fentanyl Postoperative Complications Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Bupivacaine Pain Rheumatic Diseases Pain, Postoperative |
Anesthetics, Intravenous Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Anesthetics, Local Pharmacologic Actions Adjuvants, Anesthesia |
Pathologic Processes Anesthetics, General Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid |