NCT05815563

Brief Summary

Few data are available for the PI as a tool for evaluation of peripheral block success in pediatric patients. Furthermore, there is currently no cut-off value defined for the accuracy of the PI in the detection of successful block.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

April 4, 2023

Last Update Submit

August 28, 2023

Conditions

PediatricsAnesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • Perfusion index

    The sensitivity of perfusion index in predicting success of supraclavicular brachial plexus block in pediatric patients.

    Intraoperative

Secondary Outcomes (1)

  • Temperature

    Intraoperative

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

59 pediatric patients scheduled for elective upper extremity procedures will receive general anesthesia and trained anesthesiologist will perform ultrasound guided supraclavicular brachial plexus block on the ipsilateral side of the procedure.

You may qualify if:

  • Age group: (3-14) years old. ASA class I-II

You may not qualify if:

  • Patients with age below 3 year or older than 14 years. Parent refusal. Patients with apparent infection at site of needle insertion. Patients with any coagulation disorder. Patients with known neuropathy or brachial plexus injury. Patients with any cardiac, hepatic, renal or neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Cairo, 11562, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 18, 2023

Study Start

September 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

EG(1)