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NCT05815563 Clinical Trial

Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics

Anesthesia, Local Clinical Trial

Official title:
Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block for Upper Extremity Procedures in Children.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05815563
Other study ID # MD2021
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2023
Est. completion date May 2024

Study information
Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

modify plan for intraoperative and postoperative analgesia. Perfusion index is an assessment of the pulsatile strength at a monitoring site; it is calculated by means of pulse oximetry by expressing the pulsatile signal as a percentage of the non pulsatile signal by a specialized probe, both of which are derived from the amount of infrared light absorbed.PI can provide useful information about the peripheral perfusion status of the patients and works as an index for sympathetic stimulation. Recent study suggested that PI could be used as an early and sensitive indicator to assess the development of sympathectomy induced by brachial plexus block in conscious adults; it is more sensitive than other parameters such as changes of skin temperature gradients or mean arterial pressure (MAP)

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 59
Est. completion date May 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years to 14 Years
Eligibility Inclusion Criteria: Age group: (3-14) years old. ASA class I-II Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Egypt Faculty of Medicine Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perfusion index The sensitivity of perfusion index in predicting success of supraclavicular brachial plexus block in pediatric patients. Intraoperative
Secondary Temperature The sensitivity of temperature change in predicting success of supraclavicular brachial plexus block in pediatric patients. Intraoperative
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