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Bupivacaine Versus Ropivacaine on Diaphragmatic Motility and Ventilatory Function

NCT02059070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2014-11-25

Study results available
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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.

Conditions

  • Paresis

Interventions

DRUG

Ropivacaine

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

DRUG

Bupivacaine

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

Sponsors & Collaborators

  • Wayne State University

    collaborator OTHER

  • Anesthesiology WSU/DMC-NorthStar

    lead OTHER

Principal Investigators

  • Pranav Patel, M.D. · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-01-31
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059070 on ClinicalTrials.gov