Regional Changes in Upper Limb Perfusion Following Brachial Plexus Block: A Pilot Study (RAFFAB)

March 29, 2017 updated by: Lawson Health Research Institute

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals coming for elective upper extremity surgery who would already be having a brachial plexus block for their anesthesia.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Other: Monitoring

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

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada
London Health Sciences Centre
St. Joseph's Health Care London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

October 1, 2015

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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