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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04209504
• Other study ID #: Pro00104053
• Status: Recruiting
• Start date: October 12, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: WIlliam M Bullock, MD, PhD
• Phone: 919-681-6437
• Email: william.bullock[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Paralysis
• Rotator Cuff Arthropathy of Left Shoulder
• Rotator Cuff Arthropathy of Right Shoulder
• Rotator Cuff Injuries
• Rotator Cuff Repair
• Rotator Cuff Tears
• Shoulder Arthritis
• Shoulder Disease
• Shoulder Injuries
• Shoulder Pain
• Shoulder Surgery
• Wounds and Injuries

Intervention

Diagnostic Test:
• Ultrasound
Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

Drug:
• Ropivacaine
Local anesthetic (numbing drug)
• Bupivacaine
Local anesthetic (numbing drug)

Device:
• MediPines AGM100 Advanced Respiratory Monitoring System
Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1	Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1	24 hours
Secondary	Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3	Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis in PACU, POD2, and POD 3	up to 72 hours
Secondary	Noninvasive pulmonary measures of gas exchange	Noninvasive pulmonary measures of gas exchange	up to 72 hours
Secondary	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	up to 72 hours
Secondary	Opioid consumption	Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3	up to 72 hours
Secondary	Hoarseness	Incidence of recurrent laryngeal nerve palsy (subjective)	up to 72 hours
Secondary	Horner's Syndrome	Incidence of Horner's Syndrome	up to 72 hours