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Clinical Trials/NCT06416111
NCT06416111
Completed
Not Applicable

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

Ankara City Hospital Bilkent1 site in 1 country60 target enrollmentOctober 22, 2023

Overview

Phase
Not Applicable
Intervention
NIRS
Conditions
Renal Disease, Chronic
Sponsor
Ankara City Hospital Bilkent
Enrollment
60
Locations
1
Primary Endpoint
tissue oxygenation
Status
Completed
Last Updated
last year

Overview

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.

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 .

Registry
clinicaltrials.gov
Start Date
October 22, 2023
End Date
October 10, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hija Yazıcıoğlu

Prof.MD

Ankara City Hospital Bilkent

Eligibility Criteria

Inclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: NIRS

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.

Intervention: Prilocaine

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.

Intervention: NIRS

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.

Intervention: Pinprick Test

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.

Intervention: Modified Bromage Scale

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.

Intervention: Bupivacaine

Outcomes

Primary Outcomes

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 .

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

  • 5 Point Likert Scale(at the end of the operation)

Study Sites (1)

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