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
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain Brachial Plexus Block||Procedure: Group 1 In-plane Procedure: Group 2 out of plane||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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.
- 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.
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
|United States, Texas|
|Galveston, Texas, United States, 77555|
|League City, Texas, United States, 77573|
|Principal Investigator:||Ranganathan Govindaraj, MD||UTMB|