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

This study has been terminated.
(Bupivacaine has recently been shown to inhibit osteoclast formation in vitro.)
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00314457
First received: April 12, 2006
Last updated: July 10, 2009
Last verified: July 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
Study Completion Date: April 2009
Primary Completion Date: February 2007 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Harshad Gurnaney, MBBS, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00314457     History of Changes
Other Study ID Numbers: 2005-5-4294
Study First Received: April 12, 2006
Last Updated: July 10, 2009
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

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

ClinicalTrials.gov processed this record on September 16, 2014