Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-12

Study Completion Date

2026-08-31

Brief Summary

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This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.

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Detailed Description

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This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking ASA 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third group receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist). Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound. Secondary outcomes include incidence of hemidiaphragmatic paralysis as measured by point of care ultrasound (POCUS) in the immediate postoperative period, postoperative day (POD) 1, POD2, and POD3 and noninvasive measures of pulmonary gas exchange at pre-op, post-op, POD1, POD2, and POD3. Additionally, the investigators will look at pain scores (scale of 0-10) and opioid consumption (in oral morphine equivalents) at previously defined time points listed above. Furthermore, the investigators will record known side effects of interscalene blocks including hoarseness and Horner's syndrome.

Conditions

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Shoulder Surgery Shoulder Pain Shoulder Injuries Shoulder Arthritis Shoulder Disease Rotator Cuff Tears Rotator Cuff Injuries Rotator Cuff Arthropathy of Left Shoulder Rotator Cuff Arthropathy of Right Shoulder Rotator Cuff Repair

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Continuous Perineural Catheter

Placement of preoperative continuous perineural catheter using 25 milliliters (mL) 0.5% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion.

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

Ropivacaine

Intervention Type DRUG

Local anesthetic (numbing drug)

MediPines AGM100 Advanced Respiratory Monitoring System

Intervention Type DEVICE

Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

10 mL Liposomal Bupivacaine Single Shot

Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

Bupivacaine

Intervention Type DRUG

Local anesthetic (numbing drug)

MediPines AGM100 Advanced Respiratory Monitoring System

Intervention Type DEVICE

Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

20 mL Liposomal Bupivacaine Single Shot

Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

Bupivacaine

Intervention Type DRUG

Local anesthetic (numbing drug)

MediPines AGM100 Advanced Respiratory Monitoring System

Intervention Type DEVICE

Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

Interventions

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Ultrasound

Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

Intervention Type DIAGNOSTIC_TEST

Ropivacaine

Local anesthetic (numbing drug)

Intervention Type DRUG

Bupivacaine

Local anesthetic (numbing drug)

Intervention Type DRUG

MediPines AGM100 Advanced Respiratory Monitoring System

Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

Intervention Type DEVICE

Other Intervention Names

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Naropin Liposomal bupivacaine Exparel Marcaine non-invasive respiratory monitor

Eligibility Criteria

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Inclusion Criteria

* English speaking 18-80 year old ASA 1-3 patients
* Primary shoulder surgery
* Must live within a 25 mile radius

Exclusion Criteria

* ASA 4 or 5
* Revision shoulder surgery
* Diagnosis of chronic pain
* Daily chronic opioid use (over 3 months of continuous opioid use)
* Inability to communicate pain scores or need for analgesia
* Infection at the site of block placement
* Age under 18 years old or greater than 80 years old
* Pregnant women (as determined by point-of-care serum bHCG)
* Intolerance/allergy to local anesthetics
* Weight \<50 kg
* BMI \> 40
* severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease
* Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No