Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
Information source: Rambam Health Care Campus
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative; Osteoarthritis
Intervention: Marcaine 0.166% + Fentanyl 3.33 mcg/ml (Drug); Morphine sulphate (Drug)
Phase: Phase 4
Sponsored by: Rambam Health Care Campus
Official(s) and/or principal investigator(s):
Ruth Edery, MD, Principal Investigator, Affiliation: Rambam Health Care Campus
The study purpose is to compare the effectiveness of different methods for post-operative
pain treatment after total knee replacement.
Official title: Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
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.
Minimum age: 55 Years.
Maximum age: 85 Years.
- Informed consent
- Age: 55 to 85 years
- Primary unilateral total knee replacement
- American Society of Anesthesiologists (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 (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
Locations and Contacts
Rambam Health Care Campus, Haifa 31096, Israel
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Forst J, Wolff S, Thamm P, Forst R. Pain therapy following joint replacement.A randomized study of patient-controlled analgesia versus conventional pain therapy. Arch Orthop Trauma Surg. 1999;119(5-6):267-70.
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Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92.
[No authors listed] Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995 Dec 20;274(23):1874-80. Review.
Foss NB, Kristensen MT, Kristensen BB, Jensen PS, Kehlet H. Effect of postoperative epidural analgesia on rehabilitation and pain after hip fracture surgery: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005 Jun;102(6):1197-204.
Starting date: January 2006
Ending date: March 2007
Last updated: April 10, 2007