Landmark Guided Intercostobrachial Nerve Block Versus Serratus Plane Block After Supraclavicular Plexus Block for Anesthesia in Creation of Arteriovenous Fistula in the Medial Side of the Arm

Ultrasound Guided, Landmark Guided Intercostobrachial Nerve Block Versus Serratus Plane Block After Supraclavicular Plexus Block for Anesthesia in Creation of Arteriovenous Fistula in the Medial Side of the Arm: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Arteriovenous Fistula; Serratus Plane Block; Intercostobrachial Nerve Block; Supraclavicular Plexus Block
• Intervention / Treatment: Other: Landmark Guided Intercostobrachial Nerve Block; Other: Ultrasound Guided Intercostobrachial Nerve Block; Other: Serratus Plane Block

Detailed Description

Brachial plexus block (BPB) is usually utilized for proximal arm arteriovenous access creation. It has been suggested that supraclavicular brachial plexus block (SCPB) could be an alternative and provide comparable effective anesthesia and postoperative analgesia for arm surgery, with a reduced incidence of adverse events, including hemidiaphragmatic paresis.

By performing SCPB, the inner part of the arm is not completely anesthetized because this part of the arm is innervated by the lateral cutaneous branch of the second intercostal nerve (intercostobrachial nerve (ICBN)) and the medial branch of the brachial cutaneous nerve.

Serratus plane block (SPB) was first defined in 2013 by Blanco et al. This block provides anesthesia and analgesia in the hemi-thorax, where it is applied to block the thoracic intercostal nerves, in addition to the axillary region and shoulder posteriorly.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Landmark Guided Intercostobrachial Nerve Block; 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; 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.
Experimental: Ultrasound 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.	Other: Ultrasound 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.
Experimental: Serratus Plane 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.	Other: Serratus Plane 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients who needed local anesthetic supplementation	Number of patients who needed local anesthetic supplementation will be recorded.	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of morphine consumption	Rescue analgesia of morphine will be given as 3 mg bolus if the visual analog scale (VAS) > 3 to be repeated after 30 min if pain persists until the VAS < 4. VAS will be assessed at 0, 2, 4, 8, 12 and 24 h postoperatively.	24 hours postoperatively
Patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2024
• Primary Completion (Actual): February 27, 2025
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 36264PR77/5/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No