N/A N=39 Randomized Quadruple-blind Diagnostic

Bupivacaine Versus Ropivacaine on Diaphragmatic Motility and Ventilatory Function

Paresis

Bottom Line

View on ClinicalTrials.gov: NCT02059070 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Forced Expiratory Volume at 1 Second (% Change From Baseline) — -22.4; -29.4 percentage of change from baseline

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ropivacaine (Drug); Bupivacaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Anesthesiology WSU/DMC-NorthStar
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Forced Expiratory Volume at 1 Second (% Change From Baseline)	-22.4; -29.4	—
SECONDARY Ultrasonographic Evaluation of Diaphragmatic Excursion- Operative Side Sigh Test	-81.4; -75.5	—
SECONDARY Post-operative Oxycodone Use (mg)	33.7; 35.1	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02059070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.