Postoperative Analgesia After Total Knee Arthroplasty

May 6, 2008 updated by: University of Aarhus

Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion

Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization.

The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Glostrup Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted consecutively to primary total knee arthroplasty.
  • Provided informed consent

Exclusion Criteria:

  • Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception
  • Severe chronic neurogenic pain
  • Medical treated diabetes
  • Contraindications for spinal aesthesia and epidural analgesia
  • Known hypersensitivity towards study drugs
  • Rheumatoid arthritis
  • Treatment with narcotics
  • Treatment with antidepressants
  • Severe obesity BMI>35
  • Treatment with antacid
  • Not able to speak and understand Danish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Ropivacaine, Ketorolac, adrenaline
Infiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac
Active Comparator: 2
Drug: Ropivacaine Ketorolac
Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analgésia consumption
Time Frame: 48 h
48 h

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to discharge
Cytokine level
Time Frame: 48 h
48 h
Pain scores VAS
Time Frame: 72 h
72 h
Side-effects
Time Frame: 72 h
72 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Birgitte V Christensen, M.D., Glostrup Hospital, Glostrup 2600, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 12, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (Estimate)

January 15, 2007

Study Record Updates

Last Update Posted (Estimate)

May 7, 2008

Last Update Submitted That Met QC Criteria

May 6, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-004638-33.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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