Regional Anesthesia of Cesarean Section

Not Applicable

Completed

• Conditions: Anesthesia, Obestetric
• Interventions: Device: spinal needle

• Registration Number: NCT03556267
• Lead Sponsor: Cairo University

Brief Summary

Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of post-spinal headache.

Detailed Description

Beta trace protein is specific for CSF only and it is a quantitative analytic test.

Study Timeline

• Study First Submitted: 2018-05-19
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-14
• Study Start: 2019-08-14
• Primary Completion: 2020-10-30
• Status Verified: 2021-02
• Study Completion: 2021-02-14
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• 18-45 years old
• free medical history.
• free obstetric history.

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Exclusion Criteria

• high risk pregnancy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spinal needle 27 gauqge	spinal needle	It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section.
spinal needle 25 gauage	spinal needle	It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section.

Primary Outcome Measures

Name	Time	Method
CSF sample: serum sample	One year	After insertion of an intravenous line 4 ml serum will be collected, then 0.5 ml CSF sample will be collected after insertion of the dura by the selected spinal needle before injecting the anesthetic drugs used for spinal anesthesia. Beta trace protein assay will be measured through ELISA technique in both CSF and serum samples and the ratio will be calculated and measured. This ratio will be measured for the three arms aiming at the comparison between the three devices regarding the CSF : Serum ratio.

Trial Locations

Locations (1)

Abdelrahman; 🇪🇬 Cairo, Egypt