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

NCT06416111 | Completed

• 1 other identifier: Tissue Oxygen Saturation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Disease, Chronic

Keywords

arteriovenous fistula operation; Infraclavicular nerve block; Near-infrared spectroscopy (NIRS); local anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 5 Point Likert Scale

  at the end of the operation

Study Arms (2)

Local group(Group L)

ACTIVE COMPARATOR

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; Drug: Prilocaine

Block group(Group B)

ACTIVE COMPARATOR

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; Other: Pinprick Test; Other: Modified Bromage Scale; Drug: Bupivacaine

Interventions

NIRS DEVICE

Near Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation defined as percentage (%).

Block group(Group B); Local group(Group L)

Pinprick Test OTHER

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

Block group(Group B)

Modified Bromage Scale OTHER

Assessment of motor blockade uses 4 point Modified Bromage Score. 0.Normal motor function with full extension and flexion of elbow, wrist and fingers 1. Decreased motor strengths with ability to full flexion elbow and move fingers but inability to raise arm 2. 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.

Block group(Group B)

Bupivacaine DRUG

Bupivacaine is a potent local anesthetic with unique characteristics from the amide group of local anesthetics.

Also known as: Marcaine, Sensorcaine

Block group(Group B)

Prilocaine DRUG

Prilocaine is an amide local anesthetic secondary amine with an intermediate length of duration and quick onset of action.

Also known as: Citanest, Propitocaine, Xylonest

Local group(Group L)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA III
• years old
• arteriovenous fistula operation

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Bupivacaine; Prilocaine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hija Yazıcıoğlu

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.MD

Model Details: 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 Record Dates

• First Submitted: April 26, 2024
• First Posted: May 16, 2024
• Study Start: October 22, 2023
• Primary Completion: September 10, 2024
• Study Completion: October 10, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)