Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine - Full Text View

Sponsor:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00270322

Purpose

The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.

Condition	Intervention	Phase
Pain, Postoperative Osteoarthritis	Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml Drug: Morphine sulphate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
Total dose of rescue analgesics during first 24 hours post-operation

Secondary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	January 2006
Study Completion Date:	March 2007

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:

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.

Eligibility

Ages Eligible for Study:	55 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270322

Locations

Israel
Rambam Health Care Campus
Haifa, Israel, 31096

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator:

Ruth Edery, MD

Rambam Health Care Campus

More Information

Publications:

Williams-Russo P, Sharrock NE, Haas SB, Insall J, Windsor RE, Laskin RS, Ranawat CS, Go G, Ganz SB. Randomized trial of epidural versus general anesthesia: outcomes after primary total knee replacement. Clin Orthop Relat Res. 1996 Oct;(331):199-208.

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.

Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15.

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.

ClinicalTrials.gov Identifier:	NCT00270322 History of Changes
Other Study ID Numbers:	TKR-1.CTIL
Study First Received:	December 23, 2005
Last Updated:	April 10, 2007
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

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

Additional relevant MeSH terms:

Osteoarthritis
Pain, Postoperative
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Fentanyl
Morphine
Anesthetics, Local

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012