Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2019-03-29
2019-12-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1 Inplane
Study with the technique Inplane group
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.
Group 2 out of plane
Study with the technique out of plane
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Ranganathan Govindaraj, MD
Role: PRINCIPAL_INVESTIGATOR
UTMB
Locations
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UTMB
Galveston, Texas, United States
UTMB
League City, Texas, United States
Countries
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Other Identifiers
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17-0121
Identifier Type: -
Identifier Source: org_study_id