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

Primary Purpose

Pain, Postoperative, Osteoarthritis

Status
Terminated
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Marcaine 0.166% + Fentanyl 3.33 mcg/ml
Morphine sulphate
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring total knee replacement, orthopedic surgery, post operative analgesia, continuous epidural, patients controlled analgesia, morphine, combined spinal epidural anesthesia, anesthesia, analgesia, epidural marcaine, epidural fentanyl, pain

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Health Care Campus

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
December 23, 2005
Last Updated
April 10, 2007
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT00270322
Brief Title
Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
Official Title
Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Terminated
Why Stopped
We believe regional anesth better for TKR,90% patients got epidural. Last year we started spinal morphine one shot, and found it very promissing.
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Osteoarthritis
Keywords
total knee replacement, orthopedic surgery, post operative analgesia, continuous epidural, patients controlled analgesia, morphine, combined spinal epidural anesthesia, anesthesia, analgesia, epidural marcaine, epidural fentanyl, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Marcaine 0.166% + Fentanyl 3.33 mcg/ml
Intervention Type
Drug
Intervention Name(s)
Morphine sulphate
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
Title
Total dose of rescue analgesics during first 24 hours post-operation
Secondary Outcome Measure Information:
Title
VAS (rest/movement) + total dose rescue analgesics after 24 hours post-operation until discharge
Title
Patient outcome questionnaire
Title
Physiotherapy performance VAS (rest/walking, passive extension, maximal angle, knee flexion/extension)
Title
Adverse reactions, complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Edery, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
8895639
Citation
Williams-Russo P, Sharrock NE, Haas SB, Insall J, Windsor RE, Laskin RS, Ranawat CS, Go G, Ganz SB. Randomized trial of epidural versus general anesthesia: outcomes after primary total knee replacement. Clin Orthop Relat Res. 1996 Oct;(331):199-208. doi: 10.1097/00003086-199610000-00028.
Results Reference
background
PubMed Identifier
10447620
Citation
Forst J, Wolff S, Thamm P, Forst R. Pain therapy following joint replacement.A randomized study of patient-controlled analgesia versus conventional pain therapy. Arch Orthop Trauma Surg. 1999;119(5-6):267-70. doi: 10.1007/s004020050407.
Results Reference
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PubMed Identifier
10422923
Citation
Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
Results Reference
background
PubMed Identifier
9661552
Citation
Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
Results Reference
background
PubMed Identifier
7500539
Citation
Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995 Dec 20;274(23):1874-80. doi: 10.1001/jama.1995.03530230060032.
Results Reference
background
PubMed Identifier
15915033
Citation
Foss NB, Kristensen MT, Kristensen BB, Jensen PS, Kehlet H. Effect of postoperative epidural analgesia on rehabilitation and pain after hip fracture surgery: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005 Jun;102(6):1197-204. doi: 10.1097/00000542-200506000-00020.
Results Reference
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Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine

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