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Ultrasound-Guided T2 Erector Spinae Plane Block Versus Intercostobrachial Block in AV Fistula Surgery.

NCT07754357 — Not applicable, Completed, 110 participants, Fatma Hatem Mokhtar

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Ultrasound-Guided T2 Erector Spinae Plane Block Versus Intercostobrachial Block as Adjunct to Supraclavicular Brachial Plexus Block in AV Fistula Surgery.

RegistryNCT07754357, acronym ICBN/ESP
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment110 (Actual)
SponsorFatma Hatem Mokhtar (Other); collaborators: Aswan University Hospital
ConditionsESRD (End Stage Renal Disease)
InterventionsUltrasound Guided Intercostobrachial Nerve Block, Ultrasound Guided Erector Spinae Plane Block at T2 level (Procedure)
Datesstart 2026-07-21, primary completion 2026-10-12, completion 2026-10-12, first posted 2026-08-10, last updated 2026-10-16
Locations1 site in Egypt

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-Summary

This study aims to determine whether ultrasound guided ESP block at 2nd thoracic vertebrae is non inferior to ultrasound guided ICBN block as adjunct to supraclavicular brachial plexus block in achieving complete sensory blockade of the medial upper arm during AVF superficialization

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+Detailed description

Arteriovenous fistula (AVF) superficialization is an essential procedure for patients with end-stage renal disease . The supraclavicular brachial plexus block is commonly used for upper extremity surgeries .Because the ICBN originates from the T2 nerve root below the C5-T1 nerve roots comprising the brachial plexus, brachial plexus blocks are ideally supplemented with an ICBN infiltration block for medial upper arm coverage.The ICBB requires precise ultrasound guidance to target the ICBN, which is small and variably located, making it technically challenging and time-intensive.

ESP block at T2 level can provide broad coverage, ease of Performance, superficial injection and requiring less technical expertise compared to the ICBB .

The patients are randomly allocated into 2 groups :

1. Erector spinae plane block group (Group ESP): will receive 10 ml of 0.5% bupivacaine injected into the erector spinae plane at T2 level under ultrasound guidance.
2. Intercostobrachial block group (Group ICBB): will receive 10 ml of 0.5% bupivacaine injected around intercostobrachial nerve under ultrasound guidance. • Standard Supraclavicular Brachial plexus Block will be performed for all patients using 20 ml of 0.5% bupivacaine under ultrasound guidance.

+Arms and interventions

ArmTypeInterventionsDescription
Ultrasound Guided Intercostobrachial Nerve BlockActive comparatorProcedure: Ultrasound Guided Intercostobrachial Nerve Block1. Position: patient supine with arm abducted. 2. Ultrasound setup: High frequency probe positioned at upper axillary region. 3. Technique: Needle will be advanced into subcutaneous tissue, in-plane to target intercostobrachial nerve near axillary artery. 4. Drug: 10 ml of 0.5% bupivacaine.
Ultrasound Guided Erector Spinae Plane Block at T2 levelActive comparatorProcedure: Ultrasound Guided Erector Spinae Plane Block at T2 level1. Position: patient sitting or in lateral decubitus. 2. Ultrasound setup: High frequency linear transducer will be placed in a parasagittal 2-3 cm lateral to spinous process at T2 level, erector spinae muscles will be identified superficial to the tip of T2 transverse process, patient's skin anesthetized with 3 ml of 2 % lidocaine subcutaneously, the tip of the 22- gauge 80-mm block needle (Sonoplex, Pajunk Medical, Geisingen, Germany) needle will be placed into the facial plane on the deep (anterior) aspect of erector spinae muscle. location of needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process then 10 ml of 0.5% bupivacaine will be injected into the facial plane that will be confirmed by visible hydrodissection .
  • Ultrasound Guided Intercostobrachial Nerve Block (Procedure), also known as ICBB: 1. Position: patient supine with arm abducted. 2. Ultrasound setup: High frequency probe positioned at upper axillary region. 3. Technique: Needle will be advanced into subcutaneous tissue, in-plane to target intercostobrachial nerve near axillary artery. 4. Drug: 10 ml of 0.5% bupivacaine.
  • Ultrasound Guided Erector Spinae Plane Block at T2 level (Procedure): 1. Position: patient sitting or in lateral decubitus. 2. Ultrasound setup: High frequency linear transducer will be placed in a parasagittal 2-3 cm lateral to spinous process at T2 level, erector spinae muscles will be identified superficial to the tip of T2 transverse process, patient's skin anesthetized with 3 ml of 2 % lidocaine subcutaneously, the tip of the 22- gauge 80-mm block needle(Sonoplex, Pajunk Medical, Geisingen, Germany) needle will be placed into the facial plane on the deep (anterior) aspect of erector spinae muscle. location of needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process then 10 ml of 0.5% bupivacaine will be injected into the facial plane that will be confirmed by visible hydrodissection .

+Outcome measures

Primary outcomes

  • Proportion of Participants Achieving Complete Sensory Blockade Without Discomfort, Sedation, or Conversion to General Anesthesia [30 minutes after completion of the block procedure]: Complete sensory blockade was assessed 30 minutes after completion of the block procedure. Success was defined as achievement of adequate sensory blockade without patient discomfort requiring rescue sedation and without conversion to general anesthesia. The outcome was recorded as the number and proportion of participants meeting all success criteria in each treatment group.

Secondary outcomes

  • Time to achieve complete sensory blockade. [From completion of block placement until complete sensory blockade is achieved, assessed up to 30 minutes.]: Time, in minutes, from completion of block placement to achievement of complete sensory blockade, as assessed by the study's sensory-testing procedure.
  • Patient's satisfaction (assessed using Likert scale). [At 24 hours; the postoperative assessment.]: Patient satisfaction assessed using the 5-point Likert scale and the EVAN-LR perioperative satisfaction questionnaire, as specified in the study protocol. The scoring range, interpretation of higher scores, and whether both measures were analyzed separately should be explicitly stated.
  • Total opioid consumption in 24 hours [in the first 24 hours]: Total opioid consumption in 24 hours postoperative in mg /kg
  • The visual analog scale(VAS) [in the first 12 hours]: measure a patient pain intensty ,commonly used interpretation is 0:no pain,1-3 :mild pain.4-6:moderate pain,7-10 :sever pain

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* • Adults scheduled for upper extremity surgeries under regional anesthesia.

  * Age: 18-65 years.
  * American society of Anesthesiologists (ASA) III.
  * Body Mass Index (BMI) < 35 kg/m².

Exclusion Criteria:

* •Allergy to local anesthetics.

  * Coagulopathy or infection at injection sites.
  * Pre-existing neuropathy or significant psychiatric disorders.
  * Pregnant or lactating women.

+Locations (1)

FacilityCityCountryStatus
Aswan university hospitalAswānEgypt

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