Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation

Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation With Near-infrared Spectroscopy

In arteriovenous fistula surgery, the effect of infraclavicular brachial plexus block and local anesthesia on tissue oxygenation and the effect of primary patency of the AV fistula is intended to research.

Study Overview

• Status: Completed
• Conditions: Renal Disease, Chronic
• Intervention / Treatment: Device: NIRS; Drug: Prilocaine; Other: Pinprick Test; Other: Modified Bromage Scale; Drug: Bupivacaine

Detailed Description

It is planned to include patients who are American Society of Anesthesiologists (ASA) III and between the ages of 18-80 who will undergo arteriovenous fistula surgery in the research population.In our study, patients who come to the operating room for arteriovenous fistula operation will be randomly divided into two groups.Patients who undergo simple randomization with coin toss method will be assigned to one of two groups: group Local infiltrative anesthesia (Local) and group infraclavicular brachial plexus block with 0.25% bupivacaine (Block). Local infiltrative anesthesia will be applied with 15 ml 2% prilocaine for group Local patients.For Group Block patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.Before the start of surgery, NIRS probes will be placed on the thenar ,antecubital regions of both hands and arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded .

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

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06800
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA III
• 18-80 years old
• arteriovenous fistula operation

Exclusion Criteria:

• disabled patients
• mentally retarded
• patients with coagulopathy
• hemoglobinopathy
• patients with infection in the infraclavicular area
• local anesthetic history
• peripheral neuropathy
• peripheral arterial occlusion
• failed peripheral nerve block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local group(Group L); Local infiltrative anesthesia will be applied with 15 ml 2% prilocaine for Local group patients.Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .The peripheral regional oxygen saturation values will be recorded preoperatively and every 5 minutes during the operation. Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery.	Device: NIRS; Near Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation defined as percentage (%).; Drug: Prilocaine; Prilocaine is an amide local anesthetic secondary amine with an intermediate length of duration and quick onset of action.; Other Names: Xylonest; Citanest; Propitocaine
Active Comparator: Block group(Group B); For Block group patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.The effect of the peripheral nerve block will be evaluated with 10-minute intervals until regional anesthesia is achieved.Sensory block will be evaluated with the "Pinprick Test" and motor block with the "Modified Bromage Scale". For patients who underwent a block, Grade 2 on the "Pinprick Test" and Grade 3 on the "Modified Bromage Scale" were considered suitable anesthesia conditions for the operation. Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .The peripheral regional oxygen saturation values will be recorded preoperatively and every 5 minutes during the operation. Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery.	Device: NIRS; Near Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation defined as percentage (%).; Other: Pinprick Test; With the pinprick test, the practitioner gently touches the skin with the pin and asks the patient whether it feels sharp or blunt .Test begins distally and then move proximally (aiming to test each dermatome and each main nerve). Assessment of sensorial blockade uses 3 grade system. Grade 0.Sharp pain Grade 1.Analgesia ,numbness Grade 2.Anesthesia ,no feeling; Other: Modified Bromage Scale; Assessment of motor blockade uses 4 point Modified Bromage Score. 0.Normal motor function with full extension and flexion of elbow, wrist and fingers; Decreased motor strengths with ability to full flexion elbow and move fingers but inability to raise arm; More decreased motor strengths with inability to move elbow but ability to move fingers 3.Complete motor block with inability to move elbow, wrist, and fingers.; Drug: Bupivacaine; Bupivacaine is a potent local anesthetic with unique characteristics from the amide group of local anesthetics.; Other Names: Marcaine; Sensorcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tissue oxygenation	To compare the effects of infraclavicular brachial plexus block and local infiltrative anesthesia on tissue oxygenation during arteriovenous fistula (AVF) surgeries. Near Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation defined as percentage (%).Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .	beginning and every 5 minutes till the end of surgery
primary patency of the arteriovenous fistula	To compare the effects of infraclavicular brachial plexus block and local infiltrative anesthesia on the primary patency of the arteriovenous fistula	1 month after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5 Point Likert Scale	Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale at the end of surgery. 1 point:Dissatisfaction; 5 point:Fully satisfied	at the end of the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Bromage Scale	Assessment of motor blockade uses 4 point Modified Bromage Score. 0.Normal motor function with full extension and flexion of elbow, wrist, and fingers; Decreased motor strengths with ability to full flexion elbow and move fingers but inability to raise arm; More decreased motor strengths with inability to move elbow and ability to move fingers; Complete motor block with inability to move elbow, wrist, and fingers. In this study ,motor block of Group B patients will be evaluated with the "Modified Bromage Scale".	evaluation of the satisfactory block before the surgery
Surgeon and patient satisfaction	Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery.	at the end of the operation.

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Hija Yazıcıoğlu, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2023
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): October 10, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: local anesthesia; Near-infrared spectroscopy (NIRS); arteriovenous fistula operation; Infraclavicular nerve block
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine; Prilocaine
• Other Study ID Numbers: Tissue Oxygen Saturation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No