Viewing Study NCT00421967


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Study NCT ID: NCT00421967
Status: TERMINATED
Last Update Posted: 2008-05-07
First Post: 2007-01-12
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Postoperative Analgesia After Total Knee Arthroplasty
Sponsor: University of Aarhus
Organization:

Study Overview

Official Title: Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion
Status: TERMINATED
Status Verified Date: 2008-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Interim analysis
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: