NCT06500572

Brief Summary

This study aims to compare the role of ultrasound-guided and landmark-guided intercostobrachial nerve block and serratus plane block after supraclavicular plexus block for anesthesia in the creation of an arteriovenous fistula in the medial side of the arm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

July 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

July 8, 2024

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent of patients who needed local anesthetic supplementation

    Number of patients who needed local anesthetic supplementation will be recorded.

    Intraoperatively

Secondary Outcomes (2)

  • Total amount of morphine consumption

    24 hours postoperatively

  • Patient satisfaction

    24 hours postoperatively

Study Arms (3)

Landmark Guided Intercostobrachial Nerve Block

ACTIVE COMPARATOR

In addition to the supraclavicular plexus block, the intercostobrachial nerve block block will be performed without ultrasound guidance and based on the traditional method using superficial anatomy and nerve pathway by subcutaneous injection of 20 mL of bupivacaine 0.25% at the site of the pulse.

Other: Landmark Guided Intercostobrachial Nerve Block

Ultrasound Guided Intercostobrachial Nerve Block

EXPERIMENTAL

The patient's head will be turned to the opposite side while the patient is in the supine position and the shoulder to be treated will be elevated 5- 10 cm. The high-frequency linear ultrasound probe (12-4 MHz) and the region to be treated will be prepared in sterile conditions and placed transversely across the external jugular vein at 3-4 cm above the clavicle. Between the anterior and middle scalene muscles, the imaging of the brachial plexus showed three to five hypoechoic circles. The entry will be in-plane technique using an 80-mm block needle from lateral to medial. After confirming the needle insertion site with 2 mL saline solution, a 20 mL bupivacaine 0.25% will be administered.

Other: Ultrasound Guided Intercostobrachial Nerve Block

Serratus Plane Block

EXPERIMENTAL

The patient will be placed in the lateral decubitus position with the area to be treated on the upper side. The high-frequency linear ultrasound probe and the region to be treated will be sterilized. The ultrasound probe will be placed on the anterior line at the level of fourth and fifth ribs. Images of the muscle's latissimus dorsi and serratus anterior, the ribs, and the pleura will be obtained. Subsequently, with the in-plane technique, an 80-mm block needle will be advanced between the latissimus dorsi and the serratus muscles planes in a caudal to the cranial direction. There is no blood or air in aspiration. After confirming the location of the needle with 2 mL of saline solution, (20 mL of bupivacaine 0.25%) will be administered between the two muscles.

Other: Serratus Plane Block

Interventions

In addition to the supraclavicular plexus block, the intercostobrachial nerve block block will be performed without ultrasound guidance and based on the traditional method using superficial anatomy and nerve pathway by subcutaneous injection of 20 mL of bupivacaine 0.25% at the site of the pulse.

Landmark Guided Intercostobrachial Nerve Block

The patient's head will be turned to the opposite side while the patient is in the supine position and the shoulder to be treated will be elevated 5- 10 cm. The high-frequency linear ultrasound probe (12-4 MHz) and the region to be treated will be prepared in sterile conditions and placed transversely across the external jugular vein at 3-4 cm above the clavicle. Between the anterior and middle scalene muscles, the imaging of the brachial plexus showed three to five hypoechoic circles. The entry will be in-plane technique using an 80-mm block needle from lateral to medial. After confirming the needle insertion site with 2 mL saline solution, a 20 mL bupivacaine 0.25% will be administered.

Ultrasound Guided Intercostobrachial Nerve Block

The patient will be placed in the lateral decubitus position with the area to be treated on the upper side. The high-frequency linear ultrasound probe and the region to be treated will be sterilized. The ultrasound probe will be placed on the anterior line at the level of fourth and fifth ribs. Images of the muscle's latissimus dorsi and serratus anterior, the ribs, and the pleura will be obtained. Subsequently, with the in-plane technique, an 80-mm block needle will be advanced between the latissimus dorsi and the serratus muscles planes in a caudal to the cranial direction. There is no blood or air in aspiration. After confirming the location of the needle with 2 mL of saline solution, (20 mL of bupivacaine 0.25%) will be administered between the two muscles.

Serratus Plane Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Scheduled for creation of arteriovenous fistula in the medial side of the arm.

You may not qualify if:

  • Allergy to local anesthetics.
  • Drug addiction.
  • Coagulation abnormalities.
  • Body Mass Index (BMI)≥35 kg/m2.
  • Upper extremity neuropathy.
  • Vasculitis.
  • Unstable hemodynamics.
  • History of seizures or mental illness.
  • Severe heart, kidney, and liver diseases.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 15, 2024

Study Start

July 13, 2024

Primary Completion

February 27, 2025

Study Completion

February 27, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations