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
  Purpose

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.


Condition Intervention Phase
Arthroplasty, Replacement, Knee
Drug: Ropivacaine, Ketorolac, adrenaline
Drug: Ropivacaine Ketorolac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Analgésia consumption [ Time Frame: 48 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Not able to speak and understand Danish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421967

Locations
Denmark
Glostrup Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Birgitte V Christensen, M.D. Glostrup Hospital, Glostrup 2600, Denmark
  More Information

No publications provided

Responsible Party: Kjeld Soballe, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00421967     History of Changes
Other Study ID Numbers: 2006-004638-33.
Study First Received: January 12, 2007
Last Updated: May 6, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Postoperative pain

Additional relevant MeSH terms:
Ropivacaine
Ketorolac
Ketorolac Tromethamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014