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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
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 7, 2018
Last Updated
December 1, 2020
Sponsor
The University of Texas Medical Branch, Galveston
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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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