Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
|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)|
|Estimated 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|
|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
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|