NCT02589054

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

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Status
completed

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 30, 2017

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

October 22, 2015

Last Update Submit

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

Other: Monitoring

Interventions

Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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