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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English speaking 18-80 year old ASA 1-3 patients

Primary shoulder surgery

Must live within a 25 mile radius

Disqualifiers

ASA 4 or 5

Revision shoulder surgery

Diagnosis of chronic pain

Daily chronic opioid use (over 3 months of continuous opioid use)

Trial population

Patients ages 18-80 undergoing shoulder surgery per standard of care.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasound

    Diagnostic test

    Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

  • Ropivacaine

    Drug

    Local anesthetic (numbing drug)

  • Bupivacaine

    Drug

    Local anesthetic (numbing drug)

  • MediPines AGM100 Advanced Respiratory Monitoring System

    Device

    Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Continuous Perineural Catheter3 interventions
Group B: 10 mL Liposomal Bupivacaine Single Shot3 interventions
Group C: 20 mL Liposomal Bupivacaine Single Shot3 interventions

Trial outcomes

Primary outcomes

1

Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1

Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1

Time frame
24 hours

Secondary outcomes

1

Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3

Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis in PACU, POD2, and POD 3

Time frame
up to 72 hours
2

Noninvasive pulmonary measures of gas exchange

Noninvasive pulmonary measures of gas exchange

Time frame
up to 72 hours
3

Pain scores

Numerical Rating Scale (NRS) 11 pain scores (0-10; 0=no pain, 10=worst pain ever) at Post Anesthesia Care Unit (PACU), POD1, POD2, POD3

Time frame
up to 72 hours
4

Opioid consumption

Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3

Time frame
up to 72 hours

Other outcomes

Sponsors and contacts

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