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

Phase 4

Terminated

• Conditions: Pain, Postoperative; Osteoarthritis

• Registration Number: NCT00270322
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2005-12-23
• Study First Submitted QC: 2005-12-23
• Study First Posted: 2005-12-26
• Study Start: 2006-01
• Status Verified: 2006-05
• Study Completion: 2007-03
• Last Update Submitted: 2007-04-10
• Last Update Posted: 2007-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel