Skip to main content
OpenTrials
Completed

NCT Number: NCT06416111

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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 .

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

NIRS

Device

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

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

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

  • 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.

Bupivacaine

Drug

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

Other names: Marcaine, Sensorcaine

Prilocaine

Drug

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

Other names: Citanest, Propitocaine, Xylonest

Primary outcomes

  1. tissue oxygenation

    Time frame: beginning and every 5 minutes till the end of surgery

    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 .

  2. primary patency of the arteriovenous fistula

    Time frame: 1 month after the operation

    To compare the effects of infraclavicular brachial plexus block and local infiltrative anesthesia on the primary patency of the arteriovenous fistula

Secondary outcomes

  1. 5 Point Likert Scale

    Time frame: at the end of the operation

    Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale at the end of surgery.

    1 point:Dissatisfaction; 5 point:Fully satisfied

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 16, 2024
Registry last updated
Jan 10, 2025

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.