drugset / Trial / NCT02059070

Bupivacaine Versus Ropivacaine on Diaphragmatic Motility and Ventilatory Function

NCT02059070 ↗

RandomizedParallel-groupQuadruple-blindDiagnostic

Summary

Background: Outpatient continuous interscalene brachial plexus blocks are used to control pain after shoulder surgery, with infusions of 0.125% bupivacaine or 0.2% ropivacaine. There have been no studies comparing the effects of these two formulations. The major concern is hemidiaphragmatic paresis, and since ropivacaine preferentially blocks sensory fibers, it may cause less blockade of the phrenic nerve. This study was to evaluate the effects of continuous interscalene brachial plexus infusions, with the hypothesis that respiratory function is more affected by 0.125% bupivacaine than 0.2% ropivacaine, with equal effects on pain relief. Methods: All patients underwent baseline spirometry and ultrasound evaluation of diaphragmatic excursion, followed by interscalene catheter placement for their surgery, then randomized to receive a pump containing 0.2% ropivacaine or 0.125% bupivacaine. Patients returned to the hospital the following day for spirometry, ultrasound reevaluation, and evaluation of their pain level since discharge.

Timeline

Start
2012-06
Primary completion
2013-01
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.125 % Other
Subject Ropivacaine Other / unclassified 0.2 % Other

Indications