Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00314457
Status:
TERMINATED
Last Update Posted:
2009-07-13
First Post:
2006-04-12
Brief Title:
Efficacy Study of Continuous Intraarticular Infusion in Patients Undergoing Arthroscopic Knee and Shoulder Operations
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
A Randomized Double-blind Trial Comparing the Analgesic Efficacy and Side Effects of Continuous Intraarticular Infusion of Bupivacaine Versus Normal Saline in Patients Undergoing Knee and Shoulder Operations
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Bupivacaine has recently been shown to inhibit osteoclast formation in vitro
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to determine whether the continuous intraarticular infusion of local anesthetics in the postoperative period can improve analgesia and patients satisfaction after knee and shoulder arthroscopy
Detailed Description:
We propose to evaluate the long-term efficacy of the continuous intraarticular delivery of local anesthetics via a disposable self-regulated DonJoy Pain Control infusion pump Patients will be randomly assigned to receive either an intra-articular infusion of bupivacaine 0125 or saline delivered at a rate of 5 mlhr for 48 hours by a DonJoy Pain Control infusion pump Patients will receive a femoral block FNB and a sciatic block SNB for knee arthroscopy or an interscalene block INB for shoulder arthroscopy prior to surgery After the operation patients will receive morphine via a Patient Controlled Analgesia PCA pump for pain control The patient will be admitted overnight to a Care Unit with the PCA discontinued at discharge or 24 hours whichever is earlier If clinically indicated the PCA may be extended at the discretion of the pain team Upon discharge and during the 48 hour study period the patient will receive oral oxycodone and acetaminophen The patient and their family will remove the DonJoy Pain Control infusion pump 48 hours after the surgery
Study Oversight
Has Oversight DMC:
None
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?:
None