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

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: Not yet recruiting
• Conditions: Renal Disease, Chronic
• Intervention / Treatment: Device: NIRS; Behavioral: Surgeon and patient satisfaction; Other: Pinprick Test; Other: Modified Bromage Scale

Detailed Description

It is planned to include patients who are 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 hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded .

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merve Atay; Phone Number: 05375277009; Email: drmerveatay44@gmail.com
• Study Contact Backup: Name: Hija Yazıcıoğlu; Phone Number: 05326086960; Email: hija001@hotmail.com

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06800
      • Ankara Bilkent City Hospital
      • Contact: Merve atay; Phone Number: 5375277009; Email: drmerveatay44@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- It is planned to include patients who are ASA III and between the ages of 18-80 undergoing arteriovenous fistula operation in the research population.

There will be no gender difference.

Exclusion Criteria:

• disabled patients, children, patients with difficult communicating Pinprick test and Modified Bromage Scale showing the success of peripheral nerve block , which depends on subjective evaluation and the cooperation of the patient.The verbal tests mentioned above may not be appropriate for disabled patients, children, patients with difficult communicating in operating room conditions

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group Local; Local infiltrative anesthesia will be applied with 15 ml 2% prilocaine for group Local patients.Before surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded . 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; Before surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded .; Behavioral: Surgeon and patient satisfaction; Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery.
Active Comparator: group Block; For Group Block 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".Failed block or the patients who experience pain at any time during the operation will be excluded. Before surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded . 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; Before surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded .; Behavioral: Surgeon and patient satisfaction; Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery.; Other: Pinprick Test; Sensory block of group B patients will be evaluated with the "Pinprick Test" .; Other: Modified Bromage Scale; motor block of Group B patients will be evaluated with the "Modified Bromage Scale".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near-infrared spectroscopy (NIRS)	Near Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation.In this study ,peripheral oxygenation will be measured with a NIRS device at group Local infiltrative anesthesia and group Infraclavicular brachial plexus block. Before surgery, NIRS probes will be placed on the hypothenar ,antecubital regions of both hands and both arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded .	beginning and every 5 minutes till the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).In this study ,sensory block of group B patients will be evaluated with the Pinprick Test.	evaluation of the satisfactory block before the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; 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 and ability to move fingers; 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	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

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Hija Yazıcıoğlu, Ankara Bilkent City Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 22, 2024
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: local anesthesia; Near-infrared spectroscopy (NIRS); arteriovenous fistula operation; Infraclavicular nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID 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