- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02589054
Regional Changes in Upper Limb Perfusion Following Brachial Plexus Block: A Pilot Study (RAFFAB)
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Physiologic parameter
|
30 minutes
|
Changes in skin temperature between hands from baseline to 20 minutes after unilateral axillary block.
Time Frame: 30 minutes
|
Physiologic parameter
|
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
|
Physical examination
|
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
|
Physical examination
|
30 Minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 106285
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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