Changes in Vessels After Peripheral Block

NCT05968105 | Completed

• 2 other identifiers: e.mendes - 3KAEK/2023.06.260
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Local; Vena Cava Syndrome (Inferior) (Superior); Fluid Loss; Postoperative Pain

Keywords

Vena Cava Inferior Collapsibility Index; Lateral Sagittal Infraclavicular Block; VCI-CI

Outcome Measures

Primary Outcomes (1)

• Doppler flow change from baseline to postoperative 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.

  Perioperative period

Secondary Outcomes (3)

• VAS (Visual Analog Scala) score

  Postoperative 24th hour

• Analgesic consumption

  Postoperative 24th hour

• Postoperative nausea and vomiting

  Postoperative 24th hour

Study Arms (2)

Group 1

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

Procedure: Lateral Sagittal Infraclavicular Block; Diagnostic Test: Inferior vena cava diameter <1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) > 50%

Group 2

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

Procedure: Lateral Sagittal Infraclavicular Block; Procedure: Inferior vena cava diameter >1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) < 50%

Interventions

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.

Group 1; Group 2

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.

Group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Block differences will be observed when patients who undergo routine hand surgery operations under the lateral sagittal infraclavicular block are classified according to the Vena Cava Inferior - Collapsibility Index.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Ergun Mendes

Küçükçekmece, İ̇stanbul, 34000, Turkey (Türkiye)

Location

Related Publications (1)

• Zhang H, Yuan H, Yu H, Zhang Y, Feng S. Correlation between pleth variability index and ultrasonic inferior vena cava-collapsibility index in parturients with twin pregnancies undergoing cesarean section under spinal anesthesia. Eur J Med Res. 2022 Aug 6;27(1):139. doi: 10.1186/s40001-022-00771-3.

  PMID: 35933431 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ergun Mendes

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 1, 2023
• Study Start: August 2, 2023
• Primary Completion: December 3, 2023
• Study Completion: December 3, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)