Postoperative Analgesia After Total Knee Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00421967
• Other study ID #: 2006-004638-33.
• Status: Terminated
• Phase: Phase 4
• First received: January 12, 2007
• Last updated: May 6, 2008
• Start date: January 2007
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

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

Locations

Country	Name	City	State
Denmark	Glostrup Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgésia consumption		48 h	No
Secondary	Time to discharge			No
Secondary	Cytokine level		48 h	No
Secondary	Pain scores VAS		72 h	No
Secondary	Side-effects		72 h	Yes