Evaluation of Diaphragm Movement After an Interscalene Block

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03636542

Enrollment

Registered

2018-08-17

Start date

2018-08-01

Completion date

2020-06-03

Last updated

2022-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phrenic Nerve Paralysis

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.

Interventions

DRUGliposomal bupivacaine

Experimental

DRUGbupivacaine

Active comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Diaphragm Excursion With Sigh	change from baseline to 24 hours after block	Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.

Secondary

Measure	Time frame	Description
Diaphragm Excursion With Quick Inspiratory Breath	change from baseline to 24 hours after block	Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath.
Forced Expiratory Volume in 1 Second (FEV1)	change from baseline to 24 hours after block	Evaluation of FEV1 via spirometry.
Forced Vital Capacity (FVC)	change from baseline to 24 hours after block	Evaluation of FVC via spirometry.
FEV1/FVC	change from baseline to 24 hours after block	Evaluation of FEV1/FVC percent via spirometry.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Liposomal Bupivacaine These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	10
Bupivacaine These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator	12
Total	22

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	1
Overall Study	Physician Decision	0	1
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Liposomal Bupivacaine	Bupivacaine	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	6 Participants	10 Participants	16 Participants
Age, Categorical Between 18 and 65 years	4 Participants	2 Participants	6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	6 Participants	9 Participants	15 Participants
Sex: Female, Male Male	4 Participants	3 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 12
other Total, other adverse events	0 / 10	0 / 12
serious Total, serious adverse events	0 / 10	0 / 12