Efficacy Study of Continuous Intraarticular Infusion in Patients Undergoing Arthroscopic Knee and Shoulder Operations
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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 |
- 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 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) |
-
Drug: Bupivacaine
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 |
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| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| 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 May 22, 2013