Regional Hemodynamic Parameter Changes After Spinal Anesthesia

Measurement of Regional Hemodynamic Parameters Before and After Spinal Anesthesia With Doppler USG

Spinal anesthesia is a regional anesthesia method used for surgical procedures generally involving the lower abdominal area, perineum, and lower extremities. Various tests are performed to evaluate the block level after spinal anesthesia, incluyding pinprick test, cold application, and motor examination. These tests are performed to check whether the pain, sympathetic and motor nerve fibers are affected, respectively, after the block; and good communication with the patient is important here. However, it is extremely difficult to evaluate these tests in pediatric, geriatric, mentally retarded or uncooperative patients.

Sympathectomy can be used as a criterion to evaluate the success of the block that occurs after the spinal anesthesia procedure. Sympathetic nerve fibers are the first to be affected by the block, and the success of the block can be evaluated with the revealed sympathectomy. Sympathectomy in the lower extremities after spinal block increases arterial blood flow. This increase in blood flow can be detected by the Pulsed Wave Doppler feature of USG.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia Evaluation
• Intervention / Treatment: Diagnostic test: Pulsed Wave Doppler USG examination

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Turkey
  • Pendik
    • Istanbul, Pendik, Turkey, 34899
      • Marmara University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective operation with spinal anesthesia will be recruited for the study. Posterior tibial artery velocities (peak systolic, end-diastolic) and the vessel diameters will be measured via USG Pulsed Wave Doppler mode. Three measurements will be performed: before spinal anesthesia, at the 5th and at the 10th minutes after the subarachnoid injection. The patients' sensory and motor examinations will be performed as well.

Description

Inclusion Criteria:

• Elective surgery under spinal anesthesia
• American Society of Anesthesiologists (ASA) I-II physical status

Exclusion Criteria:

• Contraindication for spinal anesthesia
• ASA physical status >II
• Vasoactive drug usage

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial velocity changes	Posterior tibial artery velocities (peak systolic, end-diastolic) and vessel diameters will be measured after the spinal anesthesia procedure.	At the 5th and 10th minutes after the spinal anesthesia procedure

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Test; Pulsed Wave Doppler; Sympathectomy
• Other Study ID Numbers: 09.2021.1406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No