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Efficacy Study of Continuous Intraarticular Infusion in Patients Undergoing Arthroscopic Knee and Shoulder Operations
This study has been suspended.
Sponsors and Collaborators: Children's Hospital of Philadelphia
Children's Anesthesiology Associates
Information provided by: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00314457
  Purpose

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.


Condition Intervention Phase
ACL Repair
Meniscectomy
Bankart Repair
Drug: Bupivacaine
Phase IV

MedlinePlus related topics: Nausea and Vomiting
Drug Information available for: Bupivacaine Bupivacaine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • To evaluate the total amount of opioids and other analgesic medications consumed in the recovery room and during the 48 hour study period (intravenous and oral). [ Time Frame: 48 hour post operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints will include the incidence of side effects, such as nausea, vomiting, sedation and itching, pain scores at defined time periods and patients' satisfaction. [ Time Frame: 48 hours post operatively ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: August 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bupivacaine
    Patients receive either normal saline or Bupivacaine in normal saline that infuses intraarticularly for 48 hours.
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 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.

  Eligibility

Ages Eligible for Study:   11 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314457

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates
Investigators
Principal Investigator: Harshad Gurnaney, MD Children's Hospital of Philadelphia
  More Information

Responsible Party: The Children's Hospital of Philadelphia ( Harshad Gurnaney, MBBS )
Study ID Numbers: 2005-5-4294
Study First Received: April 12, 2006
Last Updated: July 14, 2008
ClinicalTrials.gov Identifier: NCT00314457  
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
pain control
intra-articular pain control device
ACL repair
Bankart Repair

Study placed in the following topic categories:
Bupivacaine
Pain
Arthralgia

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009