Postoperative Analgesia After Total Knee Arthroplasty

Phase 4

Terminated

• Conditions: Arthroplasty, Replacement, Knee
• Interventions: Drug: Ropivacaine, Ketorolac, adrenaline; Drug: Ropivacaine Ketorolac

• Registration Number: NCT00421967
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-15
• Primary Completion: 2008-03
• Study Completion: 2008-04
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-06
• Last Update Posted: 2008-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ropivacaine, Ketorolac, adrenaline	-
2	Ropivacaine Ketorolac	-

Primary Outcome Measures

Name	Time	Method
Analgésia consumption	48 h

Secondary Outcome Measures

Name	Time	Method
Time to discharge
Cytokine level	48 h
Pain scores VAS	72 h
Side-effects	72 h

Trial Locations

Locations (1)

Glostrup Hospital; 🇩🇰 Glostrup, Denmark