NCT04216823

Brief Summary

The aim of the present study is to evaluate the effects of supraclavicular brachial plexus block using perfusion index in pediatric patients undergoing Upper limb surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 6, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

December 28, 2019

Last Update Submit

September 1, 2023

Conditions

Keywords

perfusion indexsupraclavicular brachial plexus blockchildren

Outcome Measures

Primary Outcomes (1)

  • perfusion index

    Correlation between success of supraclavicular brachial plexus block and perfusion index

    the time span between 1 day preoperative and 24 hours after surgery

Secondary Outcomes (3)

  • mean arterial blood pressure

    the time span between 1 day preoperative and 24 hours after surgery

  • heart rate

    the time span between 1 day preoperative and 24 hours after surgery

  • PI ratio

    up to 10 minutes

Study Arms (2)

Sevoflurane Group

sevoflurane is used for anesthetic induction

Device: perfusion index

Propofol Group

intravenous anesthetic propofol is used for anesthetic induction

Device: perfusion index

Interventions

perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients

Propofol GroupSevoflurane Group

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

ASA physical status I-II,Age 1 month-12 year,Children undergoing Upper limb surgery.

You may qualify if:

  • ASA physical status I-II
  • Children undergoing Upper limb surgery.
  • Parents' agreement.

You may not qualify if:

  • Parents' refusal.
  • Children with behavioral changes
  • Children with physical developmental delay
  • Children on treatment with sedative or anticonvulsant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Related Publications (2)

  • Chu T, Zhou S, Peng T, Tao H, Chen H, Yan X, Xin Y, Tian Z, Wang J, Deng L, Xu A. Perfusion Index Predicts the Effectiveness of Supraclavicular Brachial Plexus Block in Children Under General Anesthesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2025 Feb 22;2025:5583145. doi: 10.1155/anrp/5583145. eCollection 2025.

  • Wang J, Deng L, Xu A. Evaluation of prediction effect of perfusion index for supraclavicular brachial plexus block in children: protocol for a randomized trial. Trials. 2022 Aug 4;23(1):629. doi: 10.1186/s13063-022-06597-y.

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hong Liu, Dr.

    Huazhong university, Tongji medical college

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

December 28, 2019

First Posted

January 3, 2020

Study Start

July 6, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations