Bupivacaine Versus Ropivacaine on Diaphragmatic Motility and Ventilatory Function

Completed · Not applicable

Conditions studied: Paresis

In brief

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.

Key facts

Study ID

NCT02059070

Run by

Anesthesiology WSU/DMC-NorthStar

People needed

39

Starts

2012-06-01

Expected to finish

2013-06-01

Last updated by the study team

2014-11-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients undergoing shoulder surgery
• Patients must be willing to give written informed consent
• Patients must be able and willing to return to hospital on the first postoperative day for study follow-up procedures
• Patients must have a working phone number where they can be reached daily after surgery

You may not qualify if…

• Patients who do not receive an interscalene catheter for their respective surgery for any reason
• Patients that received an interscalene catheter, but had any surgical or catheter adverse events prior to discharge
• Patients with a history of adverse reactions to either study drug
• Patients with a history of contralateral phrenic nerve paralysis,
• Patients with a history of extensive prior lung surgery on either lung.
• Patients with a history of decreased pulmonary function
• Any emergent cases

Where it is running

• DMC Surgery Hospital — Madison Heights, Michigan, United States

Full record on ClinicalTrials.gov

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