## Protocol Section
### Identification Module
**NCT ID:** NCT06416111

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

**Official 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

#### Organization Study ID Info
**ID:** Tissue Oxygen Saturation
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2024-12-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-22

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ankara City Hospital Bilkent

#### Responsible Party

**Investigator Affiliation:** Ankara City Hospital Bilkent

**Investigator Full Name:** Hija Yazıcıoğlu

**Investigator Title:** Prof.MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 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 .

### Conditions Module

**Conditions:**

- Renal Disease, Chronic

**Keywords:**

- arteriovenous fistula operation

- Infraclavicular nerve block

- Near-infrared spectroscopy (NIRS)

- local anesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** 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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: NIRS

- Behavioral: Surgeon and patient satisfaction

**Label:** group Local

**Type:** OTHER

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: NIRS

- Behavioral: Surgeon and patient satisfaction

- Other: Pinprick Test

- Other: Modified Bromage Scale

**Label:** group Block

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group Block

- group Local

**Description:** 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 .

**Name:** NIRS

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- group Block

- group Local

**Description:** Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery.

**Name:** Surgeon and patient satisfaction

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- group Block

**Description:** Sensory block of group B patients will be evaluated with the "Pinprick Test" .

**Name:** Pinprick Test

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- group Block

**Description:** motor block of Group B patients will be evaluated with the "Modified Bromage Scale".

**Name:** Modified Bromage Scale

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** 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".

**Measure:** Modified Bromage Scale

**Time Frame:** evaluation of the satisfactory block before the surgery

**Description:** Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery.

**Measure:** Surgeon and patient satisfaction

**Time Frame:** at the end of the operation.

#### Primary Outcomes

**Description:** 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 .

**Measure:** Near-infrared spectroscopy (NIRS)

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

#### Secondary Outcomes

**Description:** 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.

**Measure:** Pinprick test

**Time Frame:** evaluation of the satisfactory block before the surgery

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drmerveatay44@gmail.com

**Name:** Merve Atay

**Phone:** 05375277009

**Role:** CONTACT

**Contact 2:**

**Email:** hija001@hotmail.com

**Name:** Hija Yazıcıoğlu

**Phone:** 05326086960

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ankara

**Contacts:**

***Contact 1:***

- **Email:** drmerveatay44@gmail.com

- **Name:** Merve atay

- **Phone:** 5375277009

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Ankara Bilkent City Hospital

**State:** Çankaya

**Zip:** 06800

#### Overall Officials

**Official 1:**

**Affiliation:** Ankara Bilkent City Hospital

**Name:** Hija Yazıcıoğlu

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001165

- Term: Arteriovenous Malformations

- ID: D000054079

- Term: Vascular Malformations

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016157

- Term: Vascular Fistula

- ID: D000014652

- Term: Vascular Diseases

- ID: D000000013

- Term: Congenital Abnormalities

- ID: D000051437

- Term: Renal Insufficiency

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8532

- Name: Fistula

- Relevance: HIGH

- As Found: Fistula

- ID: M4472

- Name: Arteriovenous Fistula

- Relevance: HIGH

- As Found: Arteriovenous Fistula

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: HIGH

- As Found: Renal Disease, Chronic

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M4473

- Name: Arteriovenous Malformations

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M27558

- Name: Vascular Malformations

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M18619

- Name: Vascular Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000001164

- Term: Arteriovenous Fistula

- ID: D000005402

- Term: Fistula

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M14191

- Name: Prilocaine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
