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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

December 23, 2005
April 10, 2007
January 2006
Not Provided
  • Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
  • Total dose of rescue analgesics during first 24 hours post-operation
  • (1) Visual analog scale (VAS)(in rest and movement) during first 24 hours post operation
  • (2) Total dose of rescue analgesics during first 24 hours post operation
Complete list of historical versions of study NCT00270322 on ClinicalTrials.gov Archive Site
  • 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
  • (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
Not Provided
Not Provided
 
Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Pain, Postoperative
  • Osteoarthritis
  • Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml
  • Drug: Morphine sulphate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
March 2007
Not Provided

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
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00270322
TKR-1.CTIL
Not Provided
Not Provided
Rambam Health Care Campus
Not Provided
Principal Investigator: Ruth Edery, MD Rambam Health Care Campus
Rambam Health Care Campus
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP