Postoperative Analgesia After Total Knee Arthroplasty

This study has been terminated.
(Interim analysis)
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00421967
First received: January 12, 2007
Last updated: May 6, 2008
Last verified: May 2008

January 12, 2007
May 6, 2008
January 2007
March 2008   (final data collection date for primary outcome measure)
Analgésia consumption [ Time Frame: 48 h ] [ Designated as safety issue: No ]
  • Analgésia consumption
  • Postoperative pain
Complete list of historical versions of study NCT00421967 on ClinicalTrials.gov Archive Site
  • Time to discharge [ Designated as safety issue: No ]
  • Cytokine level [ Time Frame: 48 h ] [ Designated as safety issue: No ]
  • Pain scores VAS [ Time Frame: 72 h ] [ Designated as safety issue: No ]
  • Side-effects [ Time Frame: 72 h ] [ Designated as safety issue: Yes ]
  • Side-effects
  • Time to discharge
  • Mobilization level
  • Cytokine level
Not Provided
Not Provided
 
Postoperative Analgesia After Total Knee Arthroplasty
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthroplasty, Replacement, Knee
  • 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
  • Experimental: 1
    Intervention: Drug: Ropivacaine, Ketorolac, adrenaline
  • Active Comparator: 2
    Intervention: Drug: Ropivacaine Ketorolac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
April 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00421967
2006-004638-33.
Yes
Kjeld Soballe, Aarhus University Hospital
University of Aarhus
Not Provided
Principal Investigator: Birgitte V Christensen, M.D. Glostrup Hospital, Glostrup 2600, Denmark
University of Aarhus
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP