The Use of NIRS in Brachial Plexus Block

The Use of NIRS of Monitorization in Arteriovenous Fistule Surgery With Brachial Plexus Block or Local Infiltration Anesthesia

The study is planed on ASA I-III, 18-80 years old 60 patients developing chronic renal failure and needing arteriovenous fistula surgery for dialysis program in Istanbul Medeniyet University Goztepe Research Hospital. Informed consent of the patients will be obtained before surgery.Patients with hemoglobinopathy, coagulopathy, wound or infection in the thenar eminence, wound and infection in the supraclavicular region on the side of the regional block, allergic to local anesthetic drugs and mental retardation will not be included in the study.

Standart monitorization (ECG, peripheral oxygen saturation and non-invasive arterial pressure monitoring) will be made. Base and 5 minutes interval values will be recorded until the end of the surgery. The pads of the NIRS monitor will be placed on the thenar eminence of both hands and fixed with the help of a draipe and basal measurements will be taken and recorded. The patients will then be divided into two groups according to computer-generated table of random numbers.

Group L patients will undergo surgical cleansing and sterile draping and infiltrate %5 bupivacaine 15ml. Group B the supraclavicular areas of the patients who will undergo surgical procedures will be sterile covered after appropriate sterilization. After the brachial plexus is visualized around the subclavian artery in the supraclavicular region with the help of Samsung ultrasound device, Bupivacaine 5% 20ml and Lidocaine 2% 10ml will be applied around the brachial plexus using a 50mm stimuplex needle. The effectiveness of the block will be evaluated by a single investigator after withdrawal of the needle, either by effective anesthesia with the block or every 10 minutes up to 30 minutes. The sensory block will be evaluated with a 3 point scale and the motor block will be evaluated routinely before and after the modified bromage scale (scored between 0 and 4). After withdrawal of the treated needle, we will contact the relevant nerve dermatome with cold application (cold SF) and ask the patient to classify the degree of cold feeling from 0 to 3. Block will be considered unsuccessful if surgical block cannot be provided after 30 minutes or if the patient experiences pain at any time during the operation. The duration of anesthesia occurring after local infiltration of Group L and the sensory and motor blockade after group B stimulation is taken will be recorded. In both groups, NIRS values will be recorded at 5 minute intervals until the end of the case after local anesthetic application.

Investigator will call the patients for primer patency of fistula one month after operation.

Study Overview

• Status: Completed
• Conditions: Arterio-venous Fistula
• Intervention / Treatment: Device: Near infrared spectroscopy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul, Turkey, 34887
    • MEDENIYET UNIVERSITY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-III,
• chronic renal failure and needing arteriovenous fistula surgery

Exclusion Criteria:

• hemoglobinopathy
• coagulopathy,
• wound or infection in the thenar eminence
• wound and infection in the supraclavicular region on the side of the regional block
• allergic to local anesthetic drugs
• mental retardation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brachial plexus blockage group	Device: Near infrared spectroscopy; It is used for detection of tissue oxygenation
Active Comparator: local anesthesia group	Device: Near infrared spectroscopy; It is used for detection of tissue oxygenation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of tissue oxygenation	Improvemen of tissue oxygenation by different anesthetic technique	85 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary patency of arteriovenous fistula	Patients will called after one month later from surgery.	1 month

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 23, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 2019-0260

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