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

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ClinicalTrials.gov Identifier: NCT04209504
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief 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 2 groups, one group receiving a perineural catheter infusing 0.2% ropivacaine and the other group receiving a single shot injection of liposomal bupivacaine plus admixed plain bupivacaine. Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.

Condition or disease Intervention/treatment Phase
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

Detailed 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 2 groups, one group receiving a perineural catheter infusing 0.2% ropivacaine and the other group receiving a single shot injection of liposomal bupivacaine plus admixed plain bupivacaine. 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.
Study Design
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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
Estimated Study Start Date : June 20, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 Diagnostic Test: Ultrasound
Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

Drug: Bupivacaine
Local anesthetic (numbing drug)
Other Names:
  • Liposomal bupivacaine
  • Exparel


Outcome Measures
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Primary Outcome Measures :
  1. Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1 [ Time Frame: 24 hours ]
    Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1


Secondary Outcome Measures :
  1. 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

  2. Noninvasive pulmonary measures of gas exchange [ Time Frame: up to 72 hours ]
    Noninvasive pulmonary measures of gas exchange

  3. 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

  4. Opioid consumption [ Time Frame: up to 72 hours ]
    Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3

  5. Hoarseness [ Time Frame: up to 72 hours ]
    Incidence of recurrent laryngeal nerve palsy (subjective)

  6. Horner's Syndrome [ Time Frame: up to 72 hours ]
    Incidence of Horner's Syndrome


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: WIlliam M Bullock, MD, PhD 919-681-6437 william.bullock@duke.edu
Contact: Amanda Kumar, MD 919-681-6437 amanda.kumar@duke.edu

Locations
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United States, North Carolina
Duke University Hospital
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         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Amanda Kumar, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04209504    
Other Study ID Numbers: Pro00104053
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: April 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.

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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
Keywords provided by Duke University:
Rotator Cuff Repair
Shoulder Surgery
Hemidiaphragmatic paralysis
 Interscalene Block
Interscalene Catheter
Interscalene Liposomal Bupivacaine
Additional relevant MeSH terms:
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Shoulder Pain
Joint Diseases
Paralysis
Rotator Cuff Injuries
Shoulder Injuries
Wounds and Injuries
Musculoskeletal Diseases
Arthralgia
Pain
Neurologic Manifestations
Signs and Symptoms
 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