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

Tracking Information

First Received Date ^ICMJE

December 23, 2005

Last Updated Date

April 10, 2007

Start Date ^ICMJE

January 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

(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

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

(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:

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Pain, Postoperative
Osteoarthritis

Intervention ^ICMJE

Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml
Drug: Morphine sulphate

Study Arm (s)

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

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

Gender

Both

Ages

55 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00270322

Other Study ID Numbers ^ICMJE

TKR-1.CTIL

Has Data Monitoring Committee

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

Information Provided By

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

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