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Clinical Trial Summary

Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.


Clinical Trial Description

Aims:

1. To compare pain ratings and supplemental analgesic requirements at discharge from PACU, 24 hours, and 48 hours and 12 weeks following 5, 10, and 20 ml boluses.

2. To compare adverse events including clinical dysphonia, Horner's syndrome, dyspnea, unexpected hospitalization, evidence of local anesthetic toxicity, and hand weakness at discharge from PACU following 5, 10, and 20 ml boluses.

3. To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10, and 20 ml boluses.

4. To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and 20 ml boluses.

5. To compare patient rating of functional outcome at baseline and at 12 weeks following 5, 10, and 20 ml boluses.

6. To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00672100
Study type Interventional
Source William Beaumont Hospitals
Contact
Status Completed
Phase N/A
Start date January 2009
Completion date August 2010

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