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Out of Plane Approach for Interscalene

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ClinicalTrials.gov Identifier: NCT03785392
Recruitment Status : Terminated (Primary investigator left the Institution)
First Posted : December 24, 2018
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
Study aims to examine the influence of out of plane interscalene approach to a brachial plexus block on the effect of phrenic nerve blockade.

Condition or disease Intervention/treatment Phase
Acute Pain Brachial Plexus Block Procedure: Group 1 In-plane Procedure: Group 2 out of plane Not Applicable

Detailed Description:

Studies have proven that there is 100% blockade of the phrenic nerve with the in-plane approach to the interscalene brachial plexus block. The patient population with pulmonary comorbidities with poor reserve cannot afford to have a further deterioration of their pulmonary status due to phrenic nerve blockade. These patients are not ideal candidates for increased opiate therapy for intraoperative and post-surgical pain as well due to further depression of their respiratory function. To optimize their pain control as well as avoid any respiratory-related morbidity and mortality, it is ideal to develop a technique which can provide appropriate brachial plexus block at the interscalene level while completely avoiding any local anesthetic spread to the phrenic nerve.

The study aims to examine the influence of out of plane interscalene approach to a brachial plexus block on the effect of phrenic nerve blockade. Practitioner preference and institutional norms often influence the in plane approach for the above-mentioned block. The most common practice at our institution is the in plane approach to the brachial plexus block.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Out of Plane Approach for Interscalene Level Brachial Plexus Block to Avoid Phrenic Nerve Involvement - a Prospective Study
Actual Study Start Date : March 29, 2019
Actual Primary Completion Date : December 8, 2019
Actual Study Completion Date : December 8, 2019

Arm Intervention/treatment
Active Comparator: Group 1 Inplane
Study with the technique Inplane group
Procedure: Group 1 In-plane

Group 1: Study will involve total of 15 patients with the procedure done in-plane. Before the block placement and after the block placement lung function will be measured.

FEV1 (forced expiratory volume in 1 second ) and FVC ( forced vital Capacity ) values will be recorded. Block will be performed in plane and postprocedure lung function test will be repeated. New values of FEV1 and FVC will be obtained after the placement of the nerve block.


Active Comparator: Group 2 out of plane
Study with the technique out of plane
Procedure: Group 2 out of plane
Group 2 study will adopt the out of plane technique and will involve a total of 15 patients in this group. We will do the procedure out of plane and will have lung function FEV1 and FVC measured bedside.FEV1 and FVC values will be recorded. Block will be performed out of plane and postprocedure lung function test will be measured. New values of FEV1 and FVC will be obtained




Primary Outcome Measures :
  1. Forced Expiratory Volume (FEV1) [ Time Frame: The change in Forced Expiratory Volume in one second (FEV1) from Baseline to 15 minutes ]
    Forced Expiratory Volume in one second (FEV1) is measured in liters.


Secondary Outcome Measures :
  1. Forced Vital Capacity (FVC) [ Time Frame: The change in Forced Vital Capacity (FVC) from Baseline to 15 minutes ]
    Forced Vital Capacity (FVC) is measured in liters.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients(18-85 years old)
  • Scheduled for elective shoulder surgery who would benefit from a preoperative interscalene approach to the brachial plexus block for intraoperative and postoperative pain relief.

Exclusion Criteria:

  • Patients with any distorted anatomy for whom the block cannot be performed accurately, such as scars, surgical fixtures at the site, active infection, any open wound or drains at the site.
  • Patients who request benzodiazepine anxiolytics such as midazolam for premedication before the procedure. Also patients who request narcotic medications as premedication before the procedure
  • Non-English and Non-Spanish speaking patients
  • Inadequate or failed blocks and inadvertently intrathecal or intravascular injection will be dropped from the study
  • Incarcerated patients
  • Expected heavy bleeding on multiple anticoagulants with markedly elevated PT ( Prothrombin time ), INR (International Normalized Ratio ), PTT ( Partial Thromboplastin Time ) levels and markedly reduced platelet counts

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): NCT03785392


Locations
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United States, Texas
UTMB
Galveston, Texas, United States, 77555
UTMB
League City, Texas, United States, 77573
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Ranganathan Govindaraj, MD UTMB
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03785392    
Other Study ID Numbers: 17-0121
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: October 2020
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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Acute Pain
Pain
Neurologic Manifestations