Evaluation of Diaphragm Movement After an Interscalene Block
1 other identifier
interventional
26
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2020
CompletedResults Posted
Study results publicly available
November 30, 2022
CompletedNovember 30, 2022
November 1, 2022
1.8 years
July 20, 2018
March 4, 2022
November 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Diaphragm Excursion With Sigh
Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.
change from baseline to 24 hours after block
Secondary Outcomes (4)
Diaphragm Excursion With Quick Inspiratory Breath
change from baseline to 24 hours after block
Forced Expiratory Volume in 1 Second (FEV1)
change from baseline to 24 hours after block
Forced Vital Capacity (FVC)
change from baseline to 24 hours after block
FEV1/FVC
change from baseline to 24 hours after block
Study Arms (2)
liposomal bupivacaine
EXPERIMENTALThese patients receive an interscalene block with liposomal bupivacaine.
bupivacaine
ACTIVE COMPARATORThese patients receive an interscalene block with bupivacaine.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Non English speaking patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univeristy of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jason Habeck
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Jason habeck, MD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2018
First Posted
August 17, 2018
Study Start
August 1, 2018
Primary Completion
June 3, 2020
Study Completion
June 3, 2020
Last Updated
November 30, 2022
Results First Posted
November 30, 2022
Record last verified: 2022-11