Cerebral Blood Flow Evaluation With Trancranial Doppler After Interscalene Nerve Block

NCT04642612 | Terminated FDA Device

• 1 other identifier: 59007
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess cerebral blood flow velocity (CBFV) following regional anesthesia for shoulder surgery. The results of this study will help to further understand the physiologic effect of the interscalene nerve block on cerebral blood flow.

Conditions

Regional Anesthesia; Horner Syndrome; Cerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

• Cerebral Blood Flow Velocity before and after interscalene nerve block

  The TCD automatically measures blood flow velocity in the main cerebral arteries of the circle of Willis. We will target the MCA which is the closest to the temporal bone therefore the most easily accessible for insonation and monitoring. We will do a bilateral monitoring.

  baseline, after 30 minutes

Secondary Outcomes (9)

• Systolic, diastolic, mean blood pressure changes before and after interscalene nerve block

  baseline, after 30 minutes

• Heart Rate

  baseline, after 30 minutes

• Respiratory Rate changes before and after interscalene nerve block

  baseline, after 30 minutes

• EtCO2 changes before and after interscalene nerve block

  baseline, after 30 minutes

• SpO2 changes before and after interscalene nerve block

  baseline, after 30 minutes

Study Arms (1)

Treatment Arm

Patients ages 18-85 years old presenting with orthopedic shoulder surgery with indication to receive preoperative insertion of interscalene nerve block.

Device: TCD Measurement

Interventions

TCD Measurement DEVICE

CBFV measurements will be acquired continuously with the patient supine and the head neutral. Analysis of CBFV measurements will be undertaken at 3 timepoints: 1. Patient awake and supine in the holding area 2. After sedation 3. After interscalene nerve block

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing orthopedic surgery with an indication for preoperative insertion of interscalene nerve block, aged 18-85 years old, and give consent to participating in study.

You may qualify if:

• Patients undergoing orthopedic surgery and with an indication for preoperative insertion of interscalene nerve block
• years old
• Give consent to participate in study

You may not qualify if:

• Cannot give consent
• Patients who are clinically unstable or require urgent/emergent intervention

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94304, United States

Location

Related Publications (5)

• Meng L, Hou W, Chui J, Han R, Gelb AW. Cardiac Output and Cerebral Blood Flow: The Integrated Regulation of Brain Perfusion in Adult Humans. Anesthesiology. 2015 Nov;123(5):1198-208. doi: 10.1097/ALN.0000000000000872.

  PMID: 26402848 BACKGROUND

• Drummond JC. Cardiac Output: The Neglected Stepchild of the Cerebral Blood Flow Physiology Family. J Neurosurg Anesthesiol. 2020 Apr;32(2):93-94. doi: 10.1097/ANA.0000000000000677. No abstract available.

  PMID: 31972625 BACKGROUND

• ter Laan M, van Dijk JM, Elting JW, Staal MJ, Absalom AR. Sympathetic regulation of cerebral blood flow in humans: a review. Br J Anaesth. 2013 Sep;111(3):361-7. doi: 10.1093/bja/aet122. Epub 2013 Apr 24.

  PMID: 23616589 BACKGROUND

• Fitch W, MacKenzie ET, Harper AM. Effects of decreasing arterial blood pressure on cerebral blood flow in the baboon. Influence of the sympathetic nervous system. Circ Res. 1975 Nov;37(5):550-7. doi: 10.1161/01.res.37.5.550.

  PMID: 153 BACKGROUND

• Seltzer JL. Hoarseness and Horner's syndrome after interscalene brachial plexus block. Anesth Analg. 1977 Jul-Aug;56(4):585-6. doi: 10.1213/00000539-197707000-00033. No abstract available.

  PMID: 560150 BACKGROUND

MeSH Terms

Conditions

Horner Syndrome

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Cavernous Sinus Syndromes; Brain Diseases; Central Nervous System Diseases; Miosis; Pupil Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Maria Bombardieri, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 24, 2020
• Study Start: March 4, 2021
• Primary Completion: May 19, 2021
• Study Completion: July 30, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (1)