NCT02084225

Brief Summary

The purpose of this study is to determine feasibility, perceived utility and sustainability of training local providers in ultrasound guided regional anesthesia for acute pain management in a limited-resource conflict setting.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

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

January 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

March 9, 2014

Last Update Submit

March 19, 2014

Conditions

Keywords

low resourceconflict settingultrasound guided regional anesthesiaacute injuriespain managementeducationultrasoundtraumaemergency department

Outcome Measures

Primary Outcomes (1)

  • Participant perceived utility of ultrasound guided nerve block

    Participants filled out a data sheet on each block performed. The participant stated yes/no if a block was found to have positive utility

    study start - ongoing (24 months)

Secondary Outcomes (1)

  • Participant course satisfaction

    at course end (5 days)

Other Outcomes (3)

  • Patient pain reduction (VAS)

    up to 18 months

  • Post procedure serious and non serious adverse event

    before and up to 48 hours after every block performed

  • Indication for use of USRA by participant

    up to 18 months of study period

Study Arms (1)

Course participants

Physicians, nurses and orthopedic officers who staff the emergency intake and orthopedic procedure area of HEAL hospital, Goma DRC, Black Lion Hospital, Addis Ababa and Kindu General Hospital in Kindu DRC. These participants recorded their nerve block intervention over one year for pain management and assessed patient pain level after 10 cc lidocaine.

Procedure: ultrasound guided regional nerve block

Interventions

participants were the physicians performing the procedure

Also known as: lidocaine 1% and 2%
Course participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants include medical doctors and orthopedic or trauma nurses (officers) who staff the emergency department and/or orthopedic procedure area where acute injuries are treated.

You may qualify if:

  • participants were chosen by hospital administration

You may not qualify if:

  • only chosen participants were included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Black Lion Hospital

Addis Ababa, Ethiopia

Location

HEAL Hospital

Goma, Republic of the Congo

Location

John Maurice Kikuni Salmu

Kindu, Republic of the Congo

Location

MeSH Terms

Conditions

AgnosiaWounds and InjuriesEmergencies

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Margaret Salmon, MD MPH

    HEAL Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Global Health Emergency Medicine, University Health Network, Toronto General Hospital

Study Record Dates

First Submitted

March 9, 2014

First Posted

March 11, 2014

Study Start

January 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations