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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314457
Recruitment Status : Terminated (Bupivacaine has recently been shown to inhibit osteoclast formation in vitro.)
First Posted : April 14, 2006
Last Update Posted : July 13, 2009
Children's Anesthesiology Associates, Ltd.
Information provided by:
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
ACL Repair Meniscectomy Bankart Repair Drug: Bupivacaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Bupivacaine
    Patients receive either normal saline or Bupivacaine in normal saline that infuses intraarticularly for 48 hours.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314457

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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, Ltd.
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Principal Investigator: Harshad Gurnaney, MD Children's Hospital of Philadelphia

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Responsible Party: Harshad Gurnaney, MBBS, The Children's Hospital of Philadelphia Identifier: NCT00314457    
Other Study ID Numbers: 2005-5-4294
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: July 13, 2009
Last Verified: July 2009
Keywords provided by Children's Hospital of Philadelphia:
pain control
intra-articular pain control device
ACL repair
Bankart Repair
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents