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

January 9, 2025 updated by: Hija Yazıcıoğlu, Ankara City Hospital Bilkent

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

  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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 .
beginning and every 5 minutes till the end of surgery
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
1 month after the operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at the end of the operation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Bromage Scale
Time Frame: evaluation of the satisfactory block before the surgery

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 and ability to move fingers
  3. 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
Time Frame: at the end of 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.
at the end of the operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hija Yazıcıoğlu, Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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