Phase 4
N=26
Evaluation of Diaphragm Movement After an Interscalene Block
Phrenic Nerve Paralysis
Bottom Line
View on ClinicalTrials.gov: NCT03636542 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Diaphragm Excursion With Sigh — 4.2; 2.9 cm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- liposomal bupivacaine (Drug); bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diaphragm Excursion With Sigh |
4.2; 2.9 | — |
| SECONDARY Diaphragm Excursion With Quick Inspiratory Breath |
1.8; 1.2 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) |
2.7; 1.8 | — |
| SECONDARY Forced Vital Capacity (FVC) |
3.2; 2.0 | — |
| SECONDARY FEV1/FVC |
86; 89.5 | — |
Summary
The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine. This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using liposome bupivacaine in an interscalene block, using ultrasound.
Eligibility Criteria
Inclusion Criteria
- All patients age 18 years and older who are scheduled for shoulder surgery with interscalene block and remain in the hospital for more than 24 hours that are being randomized into a bupivacaine versus liposomal bupivacaine interscalene block study.
Exclusion Criteria
- Non English speaking patients.
Data sourced from ClinicalTrials.gov (NCT03636542). 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.