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NCT Number: NCT06500572

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

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.

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Key information

Conditions

Intercostobrachial Nerve Block Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Serratus Plane Block Supraclavicular Plexus Block Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Landmark Guided Intercostobrachial Nerve Block

Other

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.

Ultrasound Guided Intercostobrachial Nerve Block

Other

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.

Serratus Plane Block

Other

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.

Primary outcomes

  1. Percent of patients who needed local anesthetic supplementation

    Time frame: Intraoperatively

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

Secondary outcomes

  1. Total amount of morphine consumption

    Time frame: 24 hours postoperatively

    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.

  2. Patient satisfaction

    Time frame: 24 hours postoperatively

    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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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