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NCT Number: NCT07012616

Supraclavicular Brachial Plexus Block as Opioid Sparing Technique in Pediatrics Undergoing Arteriovenous Fistula Creation

This study aims to evaluate the efficacy of supraclavicular brachial plexus block as an opioid-sparing technique in pediatric patients undergoing arteriovenous fistula creation.

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Key information

Conditions

Supraclavicular Brachial Plexus Block Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Opioid Sparing Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pediatric Vascular Diseases Vascular Fistula Vascular Malformations

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

The global incidence of end-stage renal failure (ESRF) is increasing. The preferred procedure for patients with ESRF undergoing maintenance Haemodialysis (HD) is the placement of an arteriovenous fistula (AVF).

In patients with ESRF, brachial plexus block (BPB) is frequently employed to administer anesthesia for the establishment or modification of AVF. This technique offers pain relief, sympathetic blockade, ideal surgical conditions, and a sufficient duration of postoperative block, preventing arterial spasms and graft thrombosis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 6 to 18 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I- III.
  • Undergoing arteriovenous fistula creation under general anesthesia.

Exclusion criteria

  • Allergy to local anesthetics.
  • Infection at the site of block.
  • Local infection.
  • Coagulation disorder.
  • Previously failed or revision of blocked arteriovenous fistula.

Treatment and study plan

Supraclavicular brachial plexus block

Other

Patients will receive an ultrasound-guided supraclavicular brachial plexus block.

Primary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

Secondary outcomes

  1. Total opioid consumption

    Time frame: 24 hours postoperatively

    Rescue analgesia of 0.5 µg/kg fentanyl will be given if the Wong-Baker score is 4 more.

  2. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from end of surgery to the first dose of fentanyl administrated) will be assessed.

  3. Degree of pain

    Time frame: 24 hours postoperatively

    Degree of pain will be assessed using Wong-Baker score (0 to 10), 0= no hurt and 10= hurts worst. Wong-Baker score will be assessed at post-anesthesia care unit (PACU), 4, 6, 8, 12, 18 and 24 h postoperatively.

  4. 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).

  5. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, PONV, respiratory depression, or any other complication will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Supraclavicular Brachial Plexus Block as Opioid Sparing Technique in Pediatrics Undergoing Arteriovenous Fistula Creation: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Jan 29, 2026

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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