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

This study has been terminated.
(We believe regional anesth better for TKR,90% patients got epidural. Last year we started spinal morphine one shot, and found it very promissing.)
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00270322
First received: December 23, 2005
Last updated: April 10, 2007
Last verified: May 2006
History of Changes
  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 4

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:

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:

  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.

  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:

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 June 17, 2013