Regional Changes in Upper Limb Perfusion Following Brachial Plexus Block: A Pilot Study
RAFFAB
1 other identifier
observational
18
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2015
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 30, 2017
October 1, 2015
2 months
October 22, 2015
March 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in regional blood flow and perfusion characteristics in the upper arm arteries from baseline to 20 minutes after unilateral axillary block.
Physiologic parameter
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.
30 minutes
Changes in skin temperature between hands from baseline to 20 minutes after unilateral axillary block.
30 minutes
Sensory loss in radial, ulnar, and median nerve distribution between hands from baseline to 20 minutes after unilateral axillary block.
30 minutes
Motor weakness in radial, ulnar, and median nerve distributions between hands from baseline to 20 minutes after unilateral axillary block
30 Minutes
Study Arms (1)
Patients
Interventions
Eligibility Criteria
Individuals coming for elective upper extremity surgery who would already be having a brachial plexus block for their anesthesia.
You may qualify if:
- ASA physical status I, II, III
- BMI less than or equal to 39
- Presenting for elective upper limb surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 28, 2015
Study Start
November 1, 2015
Primary Completion
January 1, 2016
Study Completion
March 1, 2016
Last Updated
March 30, 2017
Record last verified: 2015-10