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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
Sponsor:
Information provided by:
Rambam Health Care Campus

Tracking Information
First Submitted Date  ICMJE December 23, 2005
First Posted Date  ICMJE December 26, 2005
Last Update Posted Date April 11, 2007
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2007)
  • Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
  • Total dose of rescue analgesics during first 24 hours post-operation
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2005)
  • (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
Change History Complete list of historical versions of study NCT00270322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2005)
  • (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
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
Official Title  ICMJE Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
Brief Summary The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.
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  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Osteoarthritis
Intervention  ICMJE
  • Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml
  • Drug: Morphine sulphate
Study Arms Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: December 23, 2005)
80
Original Enrollment  ICMJE Same as current
Actual Study Completion Date March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00270322
Other Study ID Numbers  ICMJE TKR-1.CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruth Edery, MD Rambam Health Care Campus
PRS Account Rambam Health Care Campus
Verification Date May 2006

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