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

NCT ID: NCT06416111

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-22
• Study Completion Date: 2024-10-10

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 .

Conditions

Renal Disease, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

NIRS

Intervention Type: DEVICE

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

Prilocaine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

NIRS

Intervention Type: DEVICE

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

Pinprick Test

Intervention Type: 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

Intervention Type: 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.

Bupivacaine

Intervention Type: DRUG

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

Interventions

NIRS

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

Intervention Type: DEVICE

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

Intervention Type: 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.

Intervention Type: OTHER

Bupivacaine

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

Intervention Type: DRUG

Prilocaine

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

Intervention Type: DRUG

Other Intervention Names

Marcaine; Sensorcaine; Citanest; Propitocaine; Xylonest

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Hija Yazıcıoğlu

Prof.MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hija Yazıcıoğlu

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Tissue Oxygen Saturation

Identifier Type: -

Identifier Source: org_study_id