Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.
Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml
Drug: Morphine sulphate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine|
- 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
|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:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270322
|Rambam Health Care Campus|
|Haifa, Israel, 31096|
|Principal Investigator:||Ruth Edery, MD||Rambam Health Care Campus|