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Completed

NCT Number: NCT03636542

Evaluation of Diaphragm Movement After an Interscalene Block

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Univeristy of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liposomal bupivacaine

Drug

Experimental

Bupivacaine

Drug

Active comparator

Primary outcomes

  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 outcomes

  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

    Time frame: change from baseline to 24 hours after block

    Evaluation of FEV1/FVC percent via spirometry.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2018
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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