Pain ManagementNCT02084225
Ultrasound Guided Regional Anesthesia for Acute Injury in Low Resource Settings
An observational study of Pain Management and Acute Injuries, run by Salmon, Margaret, M.D. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain Management, Acute Injuries
- What is being tested?
- ultrasound guided regional nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2012to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- participants were chosen by hospital administration
Who cannot join
- only chosen participants were included
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Republic of the Congo2 sites
HEAL Hospital
Goma
John Maurice Kikuni Salmu
Kindu
About this study
Official title: Feasibility, Perceived Utility and Sustainability of Using Ultrasound-guided Regional Anesthesia by Local Providers in a Limited Resource Conflict Setting
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.
Read the detailed description
To the investigators knowledge, this is the first study of feasibility, perceived utility and sustainability of USRA as a pain management tool in a low-resource conflict setting and is one of the only large studies to date to assess USRA by local providers for emergent pain relief due to injury in patients presenting to an acute care center.
- Conditions
- Pain Management, Acute Injuries
- Being tested
- ultrasound guided regional nerve block
- Keywords
- low resource, conflict setting, ultrasound guided regional anesthesia, acute injuries, pain management, education, ultrasound, trauma, emergency department
- Medical subject headings
- Agnosia, Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided regional nerve blockProcedure or surgery
Also called lidocaine 1% and 2%
participants were the physicians performing the procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ultrasound guided regional nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: study start - ongoing (24 months)
Secondary outcomes (1)
Participant course satisfaction
Post course evaluation of course satisfaction and balance of didactic simulation and clinical scanning
Measured: at course end (5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salmon, Margaret, M.D.
- Collaborators
- Sonosite/Fuji Film - (in kind), The ultrasound for the study was given to the sites by Sonosite/Fuji but the company, had no other role in the study., MedShare - (in kind), The needles and syringes and kit contents were given to the sites by MedShare but the, company had no role in the study.
- Responsible party
- Principal investigator, margaret salmon, Salmon, Margaret, M.D.
- Investigators
- Margaret Salmon, MD MPH, Principal investigator, HEAL Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084225
- Sponsor's protocol ID
- NB0001
- Status last verified
- Mar 2014
- First submitted
- 9 Mar 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Perceived Utility and Sustainability of Using Ultrasound-guided Regional Anesthesia by Local Providers in a Limited Resource Conflict Setting
- ClinicalTrials.gov ID
- NCT02084225
- Acronym / sponsor ID
- NB0001
- Conditions
- Pain Management, Acute Injuries
- Keywords
- low resource, conflict setting, ultrasound guided regional anesthesia, acute injuries, pain management, education, ultrasound, trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Salmon, Margaret, M.D.
- Collaborators
- Sonosite/Fuji Film - (in kind), The ultrasound for the study was given to the sites by Sonosite/Fuji but the company, had no other role in the study., MedShare - (in kind), The needles and syringes and kit contents were given to the sites by MedShare but the, company had no role in the study.
- Study start
- Jan 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To the investigators knowledge, this is the first study of feasibility, perceived utility and sustainability of USRA as a pain management tool in a low-resource conflict setting and is one of the only large studies to date to assess USRA by local providers for emergent pain relief due to injury in patients presenting to an acute care center.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Course participants | – | Procedure: ultrasound guided regional nerve blockPhysicians, 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- participants were chosen by hospital administration
Key exclusion criteria (1 listed)
- only chosen participants were included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided regional nerve blockAlso: lidocaine 1% and 2%participants were the physicians performing the procedure | Procedure or surgery | Course participants |
Primary outcome
Participant perceived utility of ultrasound guided nerve block
Time frame: study start - ongoing (24 months)
Participants filled out a data sheet on each block performed. The participant stated yes/no if a block was found to have positive utility
1 secondary outcome
Participant course satisfaction
Time frame: at course end (5 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Salmon, MD MPH principal investigator
HEAL Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management and Acute Injuries, run by Salmon, Margaret, M.D. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Republic of the Congo, Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant perceived utility of ultrasound guided nerve block (time frame: study start - ongoing (24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.