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Evaluation of Diaphragm Movement After an Interscalene Block

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ClinicalTrials.gov Identifier: NCT03636542
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Phrenic Nerve Paralysis Drug: liposomal bupivacaine Drug: bupivacaine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Evaluation of Diaphragm Movement After an Interscalene Block
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arms and Interventions
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Arm Intervention/treatment
Experimental: liposomal bupivacaine
These patients receive an interscalene block with liposomal bupivacaine.
 Drug: liposomal bupivacaine
Experimental
Active Comparator: bupivacaine
These patients receive an interscalene block with bupivacaine.
 Drug: bupivacaine
Active comparator


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Forced expiratory volume in 1 second (FEV1) [ Time Frame: change from baseline to 24 hours after block ]
    Evaluation of FEV1 via spirometry.

  3. Forced vital capacity (FVC) [ Time Frame: change from baseline to 24 hours after block ]
    Evaluation of FVC via spirometry.

  4. FEV1/FVC ratio [ Time Frame: change from baseline to 24 hours after block ]
    Evaluation of FEV1/FVC ratio via spirometry.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636542


Contacts
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Contact: Jason Habeck, MD 612-624-9990 habe0073@umn.edu
Contact: Melissa Cohen 612-624-9990 Cohen045@umn.edu

Locations
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United States, Minnesota
Univeristy of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Melissa Cohen    612-625-7116      
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Jason habeck, MD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03636542    
Other Study ID Numbers: ANES-2018-26543
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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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
Additional relevant MeSH terms:
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Paralysis
Neurologic Manifestations
Nervous System Diseases
Bupivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents