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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test, Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

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

• Primary shoulder surgery

• Must live within a 25 mile radius

Locations
United States
North Carolina
Duke University Hospital
RECRUITING
Durham
Contact Information
Primary
WIlliam M Bullock, MD, PhD
william.bullock@duke.edu
919-681-6437
Backup
Amanda Kumar, MD
amanda.kumar@duke.edu
919-681-6437
Time Frame
Start Date: 2021-10-12
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 60
Treatments
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.
10 mL Liposomal Bupivacaine Single Shot
Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
20 mL Liposomal Bupivacaine Single Shot
Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
Related Therapeutic Areas
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov