Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
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ClinicalTrials.gov Identifier: NCT04209504 |
Recruitment Status :
Recruiting
First Posted : December 24, 2019
Last Update Posted : November 4, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 | Diagnostic Test: Ultrasound Drug: Ropivacaine Drug: Bupivacaine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block |
Actual Study Start Date : | October 22, 2020 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | January 1, 2021 |
Arm | Intervention/treatment |
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Active Comparator: Continuous Perineural Catheter
Placement of preoperative continuous perineural catheter using 25 millimeters (mL) 0.2% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion.
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Diagnostic Test: Ultrasound
Ultrasound guided evaluation of diaphragm ipsilateral to the block side. Drug: Ropivacaine Local anesthetic (numbing drug) |
Active Comparator: Liposomal Bupivacaine Single Shot
Placement of preoperative single shot using 20mL liposomal bupivacaine admixed with 5mL 0.5% bupivacaine.
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Diagnostic Test: Ultrasound
Ultrasound guided evaluation of diaphragm ipsilateral to the block side. Drug: Bupivacaine Local anesthetic (numbing drug)
Other Names:
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- Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1 [ Time Frame: 24 hours ]Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1
- Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3 [ Time Frame: up to 72 hours ]Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis in PACU, POD2, and POD 3
- Noninvasive pulmonary measures of gas exchange [ Time Frame: up to 72 hours ]Noninvasive pulmonary measures of gas exchange
- Pain scores [ Time Frame: up to 72 hours ]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
- Opioid consumption [ Time Frame: up to 72 hours ]Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3
- Hoarseness [ Time Frame: up to 72 hours ]Incidence of recurrent laryngeal nerve palsy (subjective)
- Horner's Syndrome [ Time Frame: up to 72 hours ]Incidence of Horner's Syndrome

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209504
Contact: WIlliam M Bullock, MD, PhD | 919-681-6437 | william.bullock@duke.edu | |
Contact: Amanda Kumar, MD | 919-681-6437 | amanda.kumar@duke.edu |
United States, North Carolina | |
Duke University Hospital | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: William M Bullock, MD, PhD 919-681-6437 william.bullock@duke.edu | |
Contact: Amanda Kumar, MD 919-681-6437 amanda.kumar@duke.edu | |
Principal Investigator: Amanda Kumar, MD | |
Sub-Investigator: William M Bullock, MD, PhD | |
Sub-Investigator: Jeff C Gadsden, MD |
Principal Investigator: | Amanda Kumar, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT04209504 |
Other Study ID Numbers: |
Pro00104053 |
First Posted: | December 24, 2019 Key Record Dates |
Last Update Posted: | November 4, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used once patient has completed the study. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Rotator Cuff Repair Shoulder Surgery Hemidiaphragmatic paralysis |
Interscalene Block Interscalene Catheter Interscalene Liposomal Bupivacaine |
Shoulder Pain Joint Diseases Paralysis Wounds and Injuries Rotator Cuff Injuries Shoulder Injuries Musculoskeletal Diseases Arthralgia Pain Neurologic Manifestations Rupture |
Tendon Injuries Nervous System Diseases Bupivacaine Ropivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |