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Regional Anesthesia of Cesarean Section

Role of Beta Trace Protein Assay During Spinal Anesthesia of Cesarean Section

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03556267
Enrollment
90
Registered
2018-06-14
Start date
2019-08-14
Completion date
2021-02-14
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Obestetric

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.

Interventions

It is a spinal needle with 'QUINCKE' Bevel. It is inserted in the lumbar region at the inter-space L4-L5, L4-L3 ,or L3-L2 lumber spaces, while the patient is put in the sitting position then CSF sample is taken then 2.5 ml of a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* high risk pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
CSF sample: serum sampleOne yearAfter 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026