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

Meniscectomy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00314457
• Other study ID #: 2005-5-4294
• Status: Terminated
• Phase: Phase 4
• First received: April 12, 2006
• Last updated: July 10, 2009
• Start date: August 2005
• Est. completion date: April 2009

Study information

• Verified date: July 2009
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 2009
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ACL Repair
• Bankart Repair
• Meniscectomy

Intervention

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

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Children's Anesthesiology Associates, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		48 hour post operatively	No
Secondary	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.		48 hours post operatively	No