Postoperative Analgesia After Total Knee Arthroplasty

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Analgésia consumption
  • Time Frame: 48 h
    Safety Issue?: No

Secondary Measures

• Time to discharge
  • Safety Issue?: No
• Cytokine level
  • Time Frame: 48 h
    Safety Issue?: No
• Pain scores VAS
  • Time Frame: 72 h
    Safety Issue?: No
• Side-effects
  • Time Frame: 72 h
    Safety Issue?: Yes

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Aarhus Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00421967

Study ID Number: 2006-004638-33.

ClinicalTrials.gov Identifier: NCT00421967

Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics