Pain, Postoperative, Osteoarthritis
Conditions
Keywords
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
Brief summary
The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.
Detailed description
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: 1. continuous infusion of local anesthetics + opioids into the epidural space, 2. 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.
Interventions
DRUGMarcaine 0.166% + Fentanyl 3.33 mcg/ml
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Age: 55 to 85 years * Osteoarthritis * Primary unilateral total knee replacement * American Society of Anesthesiologists (ASA) I-III * Successful spinal epidural anesthesia for surgery
Exclusion criteria
* Any cause for knee replacement other than osteoarthritis * Total knee revision (re-do) * Any contraindication for regional anesthesia * Abnormal coagulation studies * Thrombocytopenia less than 100,000/cc * Chronic renal failure (creatinine \[cr\] \< 1.8) * Neurological disease involving lower extremities * Major surgery during the last 2 weeks pre-operatively * Current or past drug or alcohol abuse * Allergy to study medications * Post-operative bleeding over 2000 cc/24 hours * Postdural puncture headache after anesthesia performance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation | — |
| Total dose of rescue analgesics during first 24 hours post-operation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Israel
Outcome results
None listed