NCT07012616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

May 31, 2025

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intraoperative fentanyl consumption

    Intraoperatively

Secondary Outcomes (5)

  • Total opioid consumption

    24 hours postoperatively

  • Time to the 1st rescue analgesia

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

  • Patient satisfaction

    24 hours postoperatively

  • Incidence of adverse events

    24 hours postoperatively

Study Arms (2)

Supraclavicular brachial plexus block group

EXPERIMENTAL

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

Other: Supraclavicular brachial plexus block

Control group

NO INTERVENTION

Patients will not receive supraclavicular brachial plexus block as a control group.

Interventions

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

Supraclavicular brachial plexus block group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

First Submitted

May 31, 2025

First Posted

June 10, 2025

Study Start

June 10, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations