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

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

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

Study Overview

• Status: Completed
• Conditions: Supraclavicular Brachial Plexus Block; Arteriovenous Fistula; Pediatric; Opioid Sparing
• Intervention / Treatment: Other: Supraclavicular brachial plexus block

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 50
• 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: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supraclavicular brachial plexus block group; Patients will receive an ultrasound-guided supraclavicular brachial plexus block.	Other: Supraclavicular brachial plexus block; Patients will receive an ultrasound-guided supraclavicular brachial plexus block.
No Intervention: Control group; Patients will not receive supraclavicular brachial plexus block as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative fentanyl consumption	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total opioid consumption	Rescue analgesia of 0.5 µg/kg fentanyl will be given if the Wong-Baker score is 4 more.	24 hours postoperatively
Time to the 1st rescue analgesia	Time to the first request for the rescue analgesia (time from end of surgery to the first dose of fentanyl administrated) will be assessed.	24 hours postoperatively
Degree of pain	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.	24 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, PONV, respiratory depression, or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Actual): January 15, 2026
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: May 31, 2025
• First Submitted That Met QC Criteria: May 31, 2025
• First Posted (Actual): June 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Arteriovenous Fistula
• Other Study ID Numbers: 36264PR1208/5/25

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