Skip to main content
OpenTrials
Completed

NCT Number: NCT05968105

Changes in Vessels After Peripheral Block

In patients with fluid deficit, vasoconstriction occurs in peripheral tissues and blood circulation is kept in the central area. It causes arterial vasodilation and hemodynamic variability by increasing the blood volume of the extremity due to the sympathectomy occurring after the block. When the investigators classify patients according to VCI-CI, it will be questioned whether there is a difference between patients' block quality and hemodynamic variability.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia, Local Fluid Loss Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Vena Cava Syndrome (Inferior) (Superior)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ergun Mendes

Küçükçekmece, İ̇stanbul, 34000, Turkey (Türkiye)

About this study

VCI-CI helps us to have an idea about the amount of fluid in patients according to the vena cava Inferior (VCI) diameter and the diameter between the inspiring and expiration. Low arterial diameter and high inspiratory and expiratory variability indicate that the patient's fluid volume may be lower.

In the measurement of VCI diameter, VCI has visualized in the craniocaudal plane thanks to the transverse ultrasound probe. Changes in VCI diameter are observed depending on the negative pressure in the thoracic area during inspiration and expiration. When the difference between this rate of change is greater than 50%, it indicates that the patient has a fluid deficit. The fact that the VCI diameter is also below 1.5 cm indicates that this amount of fluid requirement is more serious. In this study, the investigators will question whether there is a difference between patients' block quality and hemodynamic variability when they classify patients according to VCI-CI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hand and Wrist elective surgery
  • Infraclavicular block will be applied
  • American Society of Anesthesiologists (ASA) physical condition I-II
  • Patients aged 18-65 years

Exclusion criteria

  • Contraindication for central or peripheral blocks
  • Cognitive dysfunction
  • History of chronic opioid use
  • severe organ dysfunction
  • Allergy to any drug used in the study
  • Body mass index (BMI) ≥30
  • Infection in the area to be treated
  • Refusal to participate in the research

Treatment and study plan

Lateral Sagittal Infraclavicular Block

Procedure

Patients will be in the supine position and after aseptic conditions are provided, the axillary artery of the patient will be visualized in the craniocaudal plane, in the infraclavicular region and in the lateral sagittal position with the help of an 8-12 mHz linear probe. After the brachial plexus cords around the axillary artery are identified, a local anesthetic mixture will be applied in-plane between the posterior cord and the artery. During the block, patients will routinely be given a mixture of 0.25% bupivacaine + 0.5% lidocaine 0.5 mL/kg.

Inferior vena cava diameter >1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) < 50%

Procedure

While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated.

Inferior vena cava diameter <1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) > 50%

Diagnostic Test

While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated.

Primary outcomes

  1. Doppler flow change from baseline to postoperative period

    Time frame: Perioperative period

    Before the block, with the help of 8-12 mHz linear probe, the axillary artery of the patients will be determined in the lateral sagittal plane and their diameters at the time of systole and diastole will be determined. After the arterial diameters are determined, the probe will be positioned to view the artery in a linear line with 90 degree rotation. After imaging the axillary artery in the long axis, confirming it with 5 sequential flows in B-mode Doppler, PSV (Peak systolic velocity), EDV (End diastolic velocity), mV (mean velocity), RI index and PI index probe angulation at 30-60 degree angle, ultrasound will be measured automatically. After the block, the sensory and motor block times of the patients were determined and these times were recorded.

Secondary outcomes

  1. VAS (Visual Analog Scala) score

    Time frame: Postoperative 24th hour

    The patients were followed up with a VAS score between 0-10 in the postoperative period. A VAS score of 0 was defined as no pain, and 10 as the most severe pain imaginable.

  2. Analgesic consumption

    Time frame: Postoperative 24th hour

    he value in mg of the amount of analgesic consumed in the postoperative period. It was administered with a PCA device that had regular infusions and was able to deliver bolus doses at regular intervals

  3. Postoperative nausea and vomiting

    Time frame: Postoperative 24th hour

    The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

Evaluation of Lateral Sagittal Infraclavicular Block According to Vena Cava Inferior Collapsibility Index (VCI-CI): An Observational Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.