NCT03592901

Brief Summary

This study examines the sensations felt by patients receiving brachial plexus anesthesia for shoulder surgeries.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

3.4 years

First QC Date

July 9, 2018

Last Update Submit

July 19, 2018

Conditions

Phantom LimbBrachial Plexus Block

Outcome Measures

Primary Outcomes (1)

  • Verbal Report

    descriptions of sensations

    3 days

Secondary Outcomes (1)

  • Visual analog scale

    3 days

Study Arms (1)

BPA Patients

Participants that are receiving brachial plexus anesthesia for a previously planned shoulder surgery.

Drug: brachial plexus anesthesia

Interventions

brachial plexus anesthesiaDRUG

Anesthesia to some part of the brachial plexus prior to surgery. Patients are already receiving this regardless of participation in study.

BPA Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient already receiving BPA as a part of a previously planned shoulder surgery

You may qualify if:

  • Male or female subjects receiving brachial plexus anesthesia prior to upper extremity surgery
  • Age 18 years or greater
  • Ability to undergo 5-10 minutes of testing for multiple sessions: before anesthesia, following anesthesia but before surgery, following surgery while anesthesia remains effective, and throughout return of normal sensation
  • Likely to complete all required sessions

You may not qualify if:

  • Age less than 18 years old
  • Physical or mental health condition which may interfere with being able to complete all required sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTHSC

Memphis, Tennessee, 38103, United States

RECRUITING

MeSH Terms

Conditions

Phantom Limb

Interventions

Brachial Plexus Block

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPain, PostoperativePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPain

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Jack W Tsao, MD, DPhil

CONTACT

9012876326jtsao@uthsc.edu

Jen Pryweller, PhD

CONTACT

901-287-6326jprywel@uthsc.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DPhil

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

August 8, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations

US(1)