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

Not Applicable

Recruiting

• Conditions: Supraclavicular Brachial Plexus Block; Opioid Sparing; Pediatric; Arteriovenous Fistula

• Registration Number: NCT07012616
• Lead Sponsor: Tanta University

Brief Summary

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

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 Timeline

• Study First Submitted: 2025-05-31
• Study First Submitted QC: 2025-05-31
• Status Verified: 2025-06
• Study Start: 2025-06-10
• Study First Posted: 2025-06-10
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	Intraoperatively

Secondary Outcome Measures

Name	Time	Method
Total opioid consumption	24 hours postoperatively	Rescue analgesia of 0.5 µg/kg fentanyl will be given if the Wong-Baker score is 4 more.
Time to the 1st rescue analgesia	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.
Degree of pain	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.
Patient satisfaction	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).
Incidence of adverse events	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt