NCT00672100

Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

The Effect Of Initial Local Anesthetic Dose With Continuous Interscalene Analgesia On Postoperative Pain And Diaphragmatic Function In Arthroscopic Shoulder Surgery Patients: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DRUG	Ropivacaine	Initial Bolus 5 ml Ropivacaine via interscalene injection
DRUG	Ropivacaine	Initial Bolus 10 ml Ropivacaine via interscalene injection
DRUG	Ropivacaine	Initial Bolus 20 ml Ropivacaine via interscalene injection

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-02-01
• Completion: 2010-08-01
• First posted: 2008-05-06
• Last updated: 2017-03-07
• Results posted: 2013-05-23

Locations

2 sites across 1 country: United States