Shoulder Pain Clinical Trial
Official title:
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Hospital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04930393 -
Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients
|
N/A | |
Completed |
NCT03717753 -
Rotator Cuff Pathway
|
N/A | |
Completed |
NCT04454671 -
Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment
|
N/A | |
Completed |
NCT06274827 -
Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises
|
N/A | |
Not yet recruiting |
NCT05413213 -
Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder
|
N/A | |
Not yet recruiting |
NCT05043844 -
Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder
|
N/A | |
Recruiting |
NCT02903719 -
The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection.
|
Phase 4 | |
Completed |
NCT02554968 -
Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
|
||
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Recruiting |
NCT02242630 -
Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
|
N/A | |
Active, not recruiting |
NCT02843269 -
Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM
|
N/A | |
Completed |
NCT02631395 -
The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball
|
N/A | |
Completed |
NCT01885377 -
SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain
|
N/A | |
Completed |
NCT01733914 -
Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
|
Phase 2 | |
Completed |
NCT01205542 -
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function
|
N/A | |
Completed |
NCT01843660 -
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
|
Phase 4 | |
Completed |
NCT00743600 -
Ultrasound Evaluation of the Rotator Cable and Associated Structures.
|
N/A | |
Completed |
NCT00679887 -
Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points
|
Phase 1/Phase 2 | |
Completed |
NCT04058522 -
Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
|
N/A | |
Completed |
NCT03353272 -
The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
|
N/A |