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Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade

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ClinicalTrials.gov Identifier: NCT03677778
Recruitment Status : Enrolling by invitation
First Posted : September 19, 2018
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Chi-Ho Ban Tsui, Stanford University

Brief Summary:

One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. This type of block can unmask underlying respiratory issues such as shortness of breath due to a well-known and typically insignificant side effect of temporary diaphragmatic paralysis.

The nerve block may be able to use saline solution to wash out the local anesthetic and potentially reverse this respiratory side effect. Specifically, the goal of this study is to determine if the injection of saline through the nerve block catheter reverses blockade of the phrenic nerve supplying the diaphragm, without affecting the ability of the nerve block to provide pain control after surgery.


Condition or disease Intervention/treatment Phase
Anesthesia, Local Phrenic Nerve Paralysis Upper Extremity Injury Phrenic Nerve Palsy on the Left Phrenic Nerve Palsy on the Right Procedure: Normal saline injected via interscalene nerve catheter Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 30, 2022

Arm Intervention/treatment
Placebo Comparator: Placebo group
This control group will have no normal saline injected into their nerve catheter (no intervention). This group will have the following measured/ assessed after 10 minutes: incentive spirometry volume, bilateral diaphragmatic excursion via ultrasonography, pain scores (using the Numeric Rating Scale), and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group.
Other: Placebo
With the catheter covered, placebo group patients will go through the same steps as the treatment group, but no solution will be injected into the interscalene nerve block catheter.

Active Comparator: Treatment group
This group will have 30ml normal saline injected into their nerve catheter. The treatment group will have the following measured/ assessed after 10 minutes: incentive spirometry volume, bilateral diaphragmatic excursion via ultrasonography, pain scores (using the Numeric Rating Scale), and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group.
Procedure: Normal saline injected via interscalene nerve catheter
With the catheter covered, treatment group patients will receive a normal saline (NS) bolus regimen (30cc 0.9% NS) via their interscalene nerve block catheter.




Primary Outcome Measures :
  1. Diaphragmatic excursion [ Time Frame: 15 minutes (5 minutes each for a total of 3 assessments) ]
    Diaphragmatic excursion will be assessed via ultrasound before nerve block is placed, after surgery, and while receiving either the placebo or treatment.

  2. Pain scores [ Time Frame: 3 minutes (1 minute each for a total of 3 assessments) ]
    Pain scores will be assessed before nerve block is placed, after surgery, while receiving either the placebo or treatment.


Secondary Outcome Measures :
  1. Brachial plexus sensory and motor exam [ Time Frame: 6 minutes (2 minutes each for a total of 3 assessments) ]
    Secondary end points include brachial plexus sensory and motor exam changes, which will be assessed before nerve block is placed, after surgery, and while receiving either the placebo or treatment.

  2. Incentive Spirometry Volume [ Time Frame: 3 minutes (1 minute each for a total of 3 assessments) ]
    Incentive Spirometry volume will be collected before nerve block is placed, after surgery, and while receiving either the placebo or treatment. An incentive spirometer is a non-invasive device that measures how deeply you can inhale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • All adult patients (18 years and over) scheduled for surgery requiring a continuous interscalene brachial plexus nerve block catheter as part of their anesthetic care.

Exclusion criteria:

  • Concomitant life-threatening injuries and other concomitant injuries causing significant pain
  • Pregnant
  • Any condition impairing patient's ability to consent to participation in study, and an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder, infection in the vicinity of the block, and patient refusal.

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): NCT03677778


Locations
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United States, California
Stanford Health Care (SHC)
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Ban Tsui, MD Stanford University
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chi-Ho Ban Tsui, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03677778    
Other Study ID Numbers: 46830
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Paralysis
Arm Injuries
Neurologic Manifestations
Nervous System Diseases
Wounds and Injuries