CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Ropivacaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02059070
NCT02059070N/ACompleted

The Effect of Continuous Interscalene Brachial Plexus Block With 0.125% Bupivacaine Versus 0.2% Ropivacaine on Diaphragmatic Motility and Ventilatory Function

Anesthesiology WSU/DMC-NorthStar·interventional·Posted Feb 11, 2014·Updated Nov 25, 2014

In Brief

A clinical study evaluating Ropivacaine and Bupivacaine for Paresis. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParesis
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2014
Enrollment StartJun 1, 2012
Primary CompletionJan 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.4 years ago

Interventions

Ropivacainedrug

Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.

Bupivacainedrug

Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.