Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine - Article Avinza; Kadian; MS Contin; Oramorph SR
Clinical Trial: Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
This study is not yet open for patient recruitment.
Verified by Rambam Health Care Campus August 2005
|Total Knee Replacement |
| Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml |
Drug: Morphine sulphate
|Phase IV |
MedlinePlus related topics: Osteoarthritis; Pain
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Secondary Outcomes: (1) Visual analog scale (in rest and movement) after 24 hours post operation and until discharge; (2) Total dose of rescue analgesics after 24 hours post operation and until discharge; (3) Patient outcome questionnaire; (4) Physiotherapy performance throughout hospital stay (VAS-rest and walking, passive extension, maximal angle, knee flexion and extension); (5) Adverse reactions; (6) complications
Expected Total Enrollment: 80
Study start: January 2006
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.
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.
- informed consent
- age: 55 to 85 years
- primary unilateral total knee replacement
- ASA I-III
- successful spinal epidural anesthesia for surgery
- 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 (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
- post dural puncture headache after anesthesia performance
Location and Contact Information
Miri Foox 972-50-1555 email@example.com
RAMBAM Health Care Campus, Haifa, 31096, Israel
Ruth Edery, MD, Principal Investigator
Ruth Edery, MD, Principal Investigator, Rambam Health Care Campus
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Last Updated: December 23, 2005
Record first received: December 23, 2005
ClinicalTrials.gov Identifier: NCT00270322
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10