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Clinical Trials/NCT00421967
NCT00421967
Terminated
Phase 4

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

University of Aarhus1 site in 1 country80 target enrollmentJanuary 2007

Overview

Phase
Phase 4
Intervention
Ropivacaine, Ketorolac, adrenaline
Conditions
Arthroplasty, Replacement, Knee
Sponsor
University of Aarhus
Enrollment
80
Locations
1
Primary Endpoint
Analgésia consumption
Status
Terminated
Last Updated
17 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
April 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

1

Intervention: Ropivacaine, Ketorolac, adrenaline

2

Intervention: Ropivacaine Ketorolac

Outcomes

Primary Outcomes

Analgésia consumption

Time Frame: 48 h

Secondary Outcomes

  • Time to discharge
  • Cytokine level(48 h)
  • Pain scores VAS(72 h)
  • Side-effects(72 h)

Study Sites (1)

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