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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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ACL Repair Meniscectomy Bankart Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Bupivacaine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No