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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02589054
Other study ID # 106285
Secondary ID
Status Completed
Phase N/A
First received October 22, 2015
Last updated March 29, 2017
Start date November 2015
Est. completion date March 2016

Study information

Verified date October 2015
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date March 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Other:
Monitoring


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Lawson Health Research Institute London Health Sciences Centre, St. Joseph's Health Care London, University of Western Ontario, Canada

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes in the caliber of the arteries of the arm between arms from baseline to 20 minutes after unilateral axillary block. Physiologic parameter 30 minutes
Secondary Changes in skin temperature between hands from baseline to 20 minutes after unilateral axillary block. Physiologic parameter 30 minutes
Secondary Sensory loss in radial, ulnar, and median nerve distribution between hands from baseline to 20 minutes after unilateral axillary block. Physical examination 30 minutes
Secondary Motor weakness in radial, ulnar, and median nerve distributions between hands from baseline to 20 minutes after unilateral axillary block Physical examination 30 Minutes
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