Out of Plane Approach for Interscalene
Primary Purpose
Acute Pain, Brachial Plexus Block
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1 In-plane
Group 2 out of plane
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility 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
Sites / Locations
- UTMB
- UTMB
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1 Inplane
Group 2 out of plane
Arm Description
Study with the technique Inplane group
Study with the technique out of plane
Outcomes
Primary Outcome Measures
Forced Expiratory Volume (FEV1)
Forced Expiratory Volume in one second (FEV1) is measured in liters.
Secondary Outcome Measures
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is measured in liters.
Full Information
NCT ID
NCT03785392
First Posted
November 7, 2018
Last Updated
December 1, 2020
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT03785392
Brief Title
Out of Plane Approach for Interscalene
Official Title
Out of Plane Approach for Interscalene Level Brachial Plexus Block to Avoid Phrenic Nerve Involvement - a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Primary investigator left the Institution
Study Start Date
March 29, 2019 (Actual)
Primary Completion Date
December 8, 2019 (Actual)
Study Completion Date
December 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Brachial Plexus Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Inplane
Arm Type
Active Comparator
Arm Description
Study with the technique Inplane group
Arm Title
Group 2 out of plane
Arm Type
Active Comparator
Arm Description
Study with the technique out of plane
Intervention Type
Procedure
Intervention Name(s)
Group 1 In-plane
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group 2 out of plane
Intervention Description
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 Measure Information:
Title
Forced Expiratory Volume (FEV1)
Description
Forced Expiratory Volume in one second (FEV1) is measured in liters.
Time Frame
The change in Forced Expiratory Volume in one second (FEV1) from Baseline to 15 minutes
Secondary Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
Forced Vital Capacity (FVC) is measured in liters.
Time Frame
The change in Forced Vital Capacity (FVC) from Baseline to 15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ranganathan Govindaraj, MD
Organizational Affiliation
UTMB
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTMB
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
UTMB
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Out of Plane Approach for Interscalene
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