Regional Anesthesia of Cesarean Section

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Obestetric
• Intervention / Treatment: Device: spinal needle

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Abdelrahman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• high risk pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: spinal needle 27 gauqge; 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a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.
Other: spinal needle 25 gauage; 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a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): February 14, 2021

Study Registration Dates

• First Submitted: May 19, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ATC 2030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No