Anesthesia, ConductionRAFFABNCT02589054
Regional Changes in Upper Limb Perfusion Following Brachial Plexus Block: A Pilot Study
An observational study of Anesthesia, Conduction and Nerve Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Ultrasound-guided regional anesthesia is increasingly being used in the modern surgical environment to provide specific intraoperative anesthesia and postoperative analgesia. Infiltration of local anesthesics around peripheral nerves firs blocks sympathetic, then sensory, then motor nerve function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Conduction, Nerve Block, Sympathectomy
- What is being tested?
- Monitoring
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Mar 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals coming for elective upper extremity surgery who would already be having a brachial plexus block for their anesthesia.
Who may be able to join
- ASA physical status I, II, III
- BMI less than or equal to 39
- Presenting for elective upper limb surgery
- Does not meet any exclusion criteria
Who cannot join
- Age over 80
- ASA physical status IV or V
- BMI greater or equal to 40
- Language barrier precluding ability to give informed consent
- History of coagulopathy
- INR < 1.4
Show all 12Show fewer
- Platelet count < 100
- Allergy to local anesthetics
- Known peripheral vascular disease of the upper limbs
- Amputation of one or both upper limbs, not including digits
- Peripheral neurological disease
- Does not consent to participate in study
About this study
Ultrasound-guided regional anesthesia is increasingly being used in the modern surgical environment to provide specific intraoperative anesthesia and postoperative analgesia. Infiltration of local anesthesics around peripheral nerves firs blocks sympathetic, then sensory, then motor nerve function. Sympathectomy-induced vasodilation following brachial plexus block results in increased skin temperature and arterial flow within minutes.
Although it has not been shown to reliably increase diameter or cross-sectional area of distal arteries, brachial plexus block does change the pattern and quantity of blood flow to the hand. Given that the magnitude of change of flow cannot be attributed to vessel radius, the investigators suspect that the more laminar fluid dynamics are due to vascular tone.
The investigators study aims to quantify alterations in physiology and peripheral vasodilator response. The investigators anticipate that axially block will significantly improve regional blood flow.
- Being tested
- Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitoringOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in regional blood flow and perfusion characteristics in the upper arm arteries from baseline to 20 minutes after unilateral axillary block.
Physiologic parameter
Measured: 30 minutes
Secondary outcomes (4)
Changes in the caliber of the arteries of the arm between arms from baseline to 20 minutes after unilateral axillary block.
Physiologic parameter
Measured: 30 minutes
Changes in skin temperature between hands from baseline to 20 minutes after unilateral axillary block.
Physiologic parameter
Measured: 30 minutes
Sensory loss in radial, ulnar, and median nerve distribution between hands from baseline to 20 minutes after unilateral axillary block.
Physical examination
Measured: 30 minutes
Motor weakness in radial, ulnar, and median nerve distributions between hands from baseline to 20 minutes after unilateral axillary block
Physical examination
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, ConductionStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, London Health Sciences Centre, St. Joseph's Health Care London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589054
- Sponsor's protocol ID
- 106285
- Acronym
- RAFFAB
- Status last verified
- Oct 2015
- First submitted
- 22 Oct 2015
- Last updated
- 30 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Changes in Upper Limb Perfusion Following Brachial Plexus Block: A Pilot Study
- ClinicalTrials.gov ID
- NCT02589054
- Acronym / sponsor ID
- RAFFAB / 106285
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, London Health Sciences Centre, St. Joseph's Health Care London
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Oct 2015 (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.
Ultrasound-guided regional anesthesia is increasingly being used in the modern surgical environment to provide specific intraoperative anesthesia and postoperative analgesia. Infiltration of local anesthesics around peripheral nerves firs blocks sympathetic, then sensory, then motor nerve function. Sympathectomy-induced vasodilation following brachial plexus block results in increased skin temperature and arterial flow within minutes.
Although it has not been shown to reliably increase diameter or cross-sectional area of distal arteries, brachial plexus block does change the pattern and quantity of blood flow to the hand. Given that the magnitude of change of flow cannot be attributed to vessel radius, the investigators suspect that the more laminar fluid dynamics are due to vascular tone.
The investigators study aims to quantify alterations in physiology and peripheral vasodilator response. The investigators anticipate that axially block will significantly improve regional blood flow.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Monitoring |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals coming for elective upper extremity surgery who would already be having a brachial plexus block for their anesthesia.
Key inclusion criteria (4 listed)
- ASA physical status I, II, III
- BMI less than or equal to 39
- Presenting for elective upper limb surgery
- Does not meet any exclusion criteria
Key exclusion criteria (12 listed)
- Age over 80
- ASA physical status IV or V
- BMI greater or equal to 40
- Language barrier precluding ability to give informed consent
- History of coagulopathy
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 |
|---|---|---|
| Monitoring | Other | Patients |
Primary outcome
Changes in regional blood flow and perfusion characteristics in the upper arm arteries from baseline to 20 minutes after unilateral axillary block.
Time frame: 30 minutes
Physiologic parameter
4 secondary outcomes
Changes in the caliber of the arteries of the arm between arms from baseline to 20 minutes after unilateral axillary block.
Time frame: 30 minutes
Changes in skin temperature between hands from baseline to 20 minutes after unilateral axillary block.
Time frame: 30 minutes
Sensory loss in radial, ulnar, and median nerve distribution between hands from baseline to 20 minutes after unilateral axillary block.
Time frame: 30 minutes
Motor weakness in radial, ulnar, and median nerve distributions between hands from baseline to 20 minutes after unilateral axillary block
Time frame: 30 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Conduction and Nerve Block, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in regional blood flow and perfusion characteristics in the upper arm arteries from baseline to 20 minutes after unilateral axillary block. (time frame: 30 minutes). 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 30 Mar 2017.