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Postoperative Analgesia After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT00421967
Recruitment Status : Terminated (Interim analysis)
First Posted : January 15, 2007
Last Update Posted : May 7, 2008
Information provided by:
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Drug: Ropivacaine, Ketorolac, adrenaline Drug: Ropivacaine Ketorolac Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2007
Primary Completion Date : March 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Ketorolac
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Analgésia consumption [ Time Frame: 48 h ]

Secondary Outcome Measures :
  1. Time to discharge
  2. Cytokine level [ Time Frame: 48 h ]
  3. Pain scores VAS [ Time Frame: 72 h ]
  4. Side-effects [ Time Frame: 72 h ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421967

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

Responsible Party: Kjeld Soballe, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00421967     History of Changes
Other Study ID Numbers: 2006-004638-33.
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: May 2008

Keywords provided by University of Aarhus:
Postoperative pain

Additional relevant MeSH terms:
Ketorolac Tromethamine
Epinephryl borate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents