Evaluation of Diaphragm Movement After an Interscalene Block
Primary Purpose
Phrenic Nerve Paralysis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
liposomal bupivacaine
bupivacaine
Sponsored by
About this trial
This is an interventional screening trial for Phrenic Nerve Paralysis
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.
Sites / Locations
- Univeristy of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
liposomal bupivacaine
bupivacaine
Arm Description
These patients receive an interscalene block with liposomal bupivacaine.
These patients receive an interscalene block with bupivacaine.
Outcomes
Primary Outcome Measures
Diaphragm Excursion With Sigh
Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.
Secondary Outcome Measures
Diaphragm Excursion With Quick Inspiratory Breath
Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath.
Forced Expiratory Volume in 1 Second (FEV1)
Evaluation of FEV1 via spirometry.
Forced Vital Capacity (FVC)
Evaluation of FVC via spirometry.
FEV1/FVC
Evaluation of FEV1/FVC percent via spirometry.
Full Information
NCT ID
NCT03636542
First Posted
July 20, 2018
Last Updated
November 8, 2022
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03636542
Brief Title
Evaluation of Diaphragm Movement After an Interscalene Block
Official Title
Evaluation of Diaphragm Movement After an Interscalene Block
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 3, 2020 (Actual)
Study Completion Date
June 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study will be run concurrently with two other studies comparing bupivacaine to Liposomal Bupivacaine in shoulder surgeries. We will use already randomized patients for our randomization process. For this study in particular we will use an ultrasound machine to scan the diaphragm of any patient who had an Interscalene Block for Total Shoulder Arthroplasy or Rotator Cuff Repair. Patients are to be scanned in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as an acoustic window. M Mode will be applied and the range of diaphragmatic movement from the resting expiratory position to deep inspiration (sigh test) will be recorded as was the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The blocks will be done regardless of the study as they are standard of care for pain control. The only intervention is ultrasound examination of the patient's diaphragm at baseline, 3 hours post block in recovery room and on post-operative day 1, and basic spirometry to record FEV1 and FVC via a portable spirometer at the same time points. If patients did stay in hospital on postoperative day 2 we would also evaluate their diaphragm function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phrenic Nerve Paralysis
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liposomal bupivacaine
Arm Type
Experimental
Arm Description
These patients receive an interscalene block with liposomal bupivacaine.
Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Description
These patients receive an interscalene block with bupivacaine.
Intervention Type
Drug
Intervention Name(s)
liposomal bupivacaine
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
Active comparator
Primary Outcome Measure Information:
Title
Diaphragm Excursion With Sigh
Description
Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.
Time Frame
change from baseline to 24 hours after block
Secondary Outcome Measure Information:
Title
Diaphragm Excursion With Quick Inspiratory Breath
Description
Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath.
Time Frame
change from baseline to 24 hours after block
Title
Forced Expiratory Volume in 1 Second (FEV1)
Description
Evaluation of FEV1 via spirometry.
Time Frame
change from baseline to 24 hours after block
Title
Forced Vital Capacity (FVC)
Description
Evaluation of FVC via spirometry.
Time Frame
change from baseline to 24 hours after block
Title
FEV1/FVC
Description
Evaluation of FEV1/FVC percent via spirometry.
Time Frame
change from baseline to 24 hours after block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason habeck, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
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Evaluation of Diaphragm Movement After an Interscalene Block
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