Evaluation of Diaphragm Movement After an Interscalene Block
November 8, 2022 updated by: University of Minnesota
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Univeristy of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: liposomal bupivacaine
These patients receive an interscalene block with liposomal bupivacaine.
|
Experimental
|
|
ACTIVE_COMPARATOR: bupivacaine
These patients receive an interscalene block with bupivacaine.
|
Active comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragm Excursion With Sigh
Time Frame: change from baseline to 24 hours after block
|
Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.
|
change from baseline to 24 hours after block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragm Excursion With Quick Inspiratory Breath
Time Frame: change from baseline to 24 hours after block
|
Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath.
|
change from baseline to 24 hours after block
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: change from baseline to 24 hours after block
|
Evaluation of FEV1 via spirometry.
|
change from baseline to 24 hours after block
|
|
Forced Vital Capacity (FVC)
Time Frame: change from baseline to 24 hours after block
|
Evaluation of FVC via spirometry.
|
change from baseline to 24 hours after block
|
|
FEV1/FVC
Time Frame: change from baseline to 24 hours after block
|
Evaluation of FEV1/FVC percent via spirometry.
|
change from baseline to 24 hours after block
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2018
Primary Completion (ACTUAL)
June 3, 2020
Study Completion (ACTUAL)
June 3, 2020
Study Registration Dates
First Submitted
July 20, 2018
First Submitted That Met QC Criteria
August 15, 2018
First Posted (ACTUAL)
August 17, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANES-2018-26543
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.