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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04216823
Other study ID # PISP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 6, 2021
Est. completion date June 30, 2023

Study information

Verified date September 2023
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The role of 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. The aim of the present study is to assess the effects of perfusion index on success of supraclavicular brachial plexus block in pediatric patients.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Month to 12 Years
Eligibility Inclusion Criteria: - ASA physical status I-II - Children undergoing Upper limb surgery. - Parents' agreement. Exclusion Criteria: - Parents' refusal. - Children with behavioral changes - Children with physical developmental delay - Children on treatment with sedative or anticonvulsant.

Study Design


Related Conditions & MeSH terms

  • Supraclavicular Brachial Plexus Block

Intervention

Device:
perfusion index
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

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 mean arterial blood pressure perioperative mean arterial blood pressure in mmHg the time span between 1 day preoperative and 24 hours after surgery
Secondary heart rate perioperative heart rate as beat/min the time span between 1 day preoperative and 24 hours after surgery
Secondary PI ratio Correlate between baseline PI and 10min after supraclavicular brachial plexus block up to 10 minutes
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Completed NCT04508894 - Ketamine Versus Dexmedetomidine in Supraclavicular Brachial Plexus Block N/A
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