Postoperative Analgesia After Total Knee Arthroplasty

Overview

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.

Full Title of Study: “Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2008

Interventions

  • 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
  • Drug: Ropivacaine Ketorolac
    • Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg

Arms, Groups and Cohorts

  • Experimental: 1
  • Active Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • Analg├ęsia consumption
    • Time Frame: 48 h

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Provider of Information About this Clinical Study
    • Kjeld Soballe, Aarhus University Hospital
  • Overall Official(s)
    • Birgitte V Christensen, M.D., Principal Investigator, Glostrup Hospital, Glostrup 2600, Denmark

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