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
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Children's Anesthesiology Associates, Ltd. |
United States,
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 |
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