An interventional study of spinal needle in Anesthesia, Obestetric, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-16.
Sponsored by Cairo University · Not applicable, Interventional, and Health services research
Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of post-spinal headache.
Beta trace protein is specific for CSF only and it is a quantitative analytic test.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section.
Device: 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.
Device: spinal needle
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a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.
CSF sample: serum sample
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.
Time frame: One year
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Cairo University