Trial | NCT00314457  Report issue

Title

Efficacy Study of Continuous Intraarticular Infusion in Patients Undergoing Arthroscopic Knee and Shoulder Operations
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    16
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.
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 0.125%, or saline delivered at a rate of 5 ml/hr 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 Started
Aug 31
2005
Primary Completion
Feb 28
2007
Study Completion
Apr 30
2009
Last Update
Jul 13
2009
Estimate

Drug Bupivacaine

Patients receive either normal saline or Bupivacaine in normal saline that infuses intraarticularly for 48 hours.

Criteria 

Inclusion Criteria:

Children between the ages of 11 and 19 years old.
Knee and shoulder arthroscopy procedures

Exclusion Criteria:

Contraindications to Femoral-Interscalene Nerve Block
Conditions that affect the proper evaluation of pain and side effects.
Intake of NSAIDs or opioids in the 12 hours prior to the operation
Allergy to study medications
No Results Posted