Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
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|ClinicalTrials.gov Identifier: NCT00270322|
Recruitment Status : Terminated (We believe regional anesth better for TKR,90% patients got epidural. Last year we started spinal morphine one shot, and found it very promissing.)
First Posted : December 26, 2005
Last Update Posted : April 11, 2007
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Osteoarthritis||Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml Drug: Morphine sulphate||Phase 4|
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:
- continuous infusion of local anesthetics + opioids into the epidural space,
- patient controlled analgesia with IV Morphine.
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine|
|Study Start Date :||January 2006|
|Actual Study Completion Date :||March 2007|
- Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
- Total dose of rescue analgesics during first 24 hours post-operation
- VAS (rest/movement) + total dose rescue analgesics after 24 hours post-operation until discharge
- Patient outcome questionnaire
- Physiotherapy performance VAS (rest/walking, passive extension, maximal angle, knee flexion/extension)
- Adverse reactions, complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270322
|Rambam Health Care Campus|
|Haifa, Israel, 31096|
|Principal Investigator:||Ruth Edery, MD||Rambam Health Care Campus|