NCT03785392

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 29, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2019

Completed
Last Updated

December 3, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

November 7, 2018

Last Update Submit

December 1, 2020

Conditions

Acute PainBrachial Plexus Block

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume (FEV1)

    Forced Expiratory Volume in one second (FEV1) is measured in liters.

    The change in Forced Expiratory Volume in one second (FEV1) from Baseline to 15 minutes

Secondary Outcomes (1)

  • Forced Vital Capacity (FVC)

    The change in Forced Vital Capacity (FVC) from Baseline to 15 minutes

Study Arms (2)

Group 1 Inplane

ACTIVE COMPARATOR

Study with the technique Inplane group

Procedure: Group 1 In-plane

Group 2 out of plane

ACTIVE COMPARATOR

Study with the technique out of plane

Procedure: Group 2 out of plane

Interventions

Group 1 In-planePROCEDURE

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 1 Inplane
Group 2 out of planePROCEDURE

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

Group 2 out of plane

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UTMB

Galveston, Texas, 77555, United States

Location

UTMB

League City, Texas, 77573, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ranganathan Govindaraj, MD

    UTMB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

December 24, 2018

Study Start

March 29, 2019

Primary Completion

December 8, 2019

Study Completion

December 8, 2019

Last Updated

December 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)