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

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ClinicalTrials.gov Identifier: NCT00270322
Recruitment Status : 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.)
First Posted : December 26, 2005
Last Update Posted : April 11, 2007
Information provided by:
Rambam Health Care Campus

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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Osteoarthritis Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml Drug: Morphine sulphate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
Study Start Date : January 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Primary Outcome Measures :
  1. Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
  2. Total dose of rescue analgesics during first 24 hours post-operation

Secondary Outcome Measures :
  1. VAS (rest/movement) + total dose rescue analgesics after 24 hours post-operation until discharge
  2. Patient outcome questionnaire
  3. Physiotherapy performance VAS (rest/walking, passive extension, maximal angle, knee flexion/extension)
  4. Adverse reactions, complications

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270322

Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Ruth Edery, MD Rambam Health Care Campus

ClinicalTrials.gov Identifier: NCT00270322     History of Changes
Other Study ID Numbers: TKR-1.CTIL
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: May 2006

Keywords provided by Rambam Health Care Campus:
total knee replacement
orthopedic surgery
post operative analgesia
continuous epidural
patients controlled analgesia
combined spinal epidural anesthesia
epidural marcaine
epidural fentanyl

Additional relevant MeSH terms:
Pain, Postoperative
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Local