Anesthesia, ObestetricNCT03556267
Regional Anesthesia of Cesarean Section
A study testing spinal needle in people with Anesthesia, Obestetric, run by Cairo University at 1 site in Egypt.
Trial summary
Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of post-spinal headache. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Obestetric
- What is being tested?
- spinal needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Aug 2019to 14 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old
- free medical history.
- free obstetric history.
Who cannot join
- high risk pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Beta trace protein is specific for CSF only and it is a quantitative analytic test.
- Conditions
- Anesthesia, Obestetric
- Being tested
- spinal needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal needleDevice
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a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| spinal needle 27 gauqge | Other | It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section. Receives: Device: spinal needle |
| spinal needle 25 gauage | Other | It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section. Receives: Device: spinal needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start14 Aug 2019
- Primary completion30 Oct 2020
- Study completion14 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, ObestetricStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556267
- Sponsor's protocol ID
- ATC 2030
- Status last verified
- Feb 2021
- First submitted
- 19 May 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Beta Trace Protein Assay During Spinal Anesthesia of Cesarean Section
- ClinicalTrials.gov ID
- NCT03556267
- Acronym / sponsor ID
- ATC 2030
- Conditions
- Anesthesia, Obestetric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 14 Feb 2021 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal needle 27 gauqge | Other | Device: spinal needleIt 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 | Other | Device: spinal needleIt is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-45 years old
- free medical history.
- free obstetric history.
Key exclusion criteria (1 listed)
- high risk pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal needleIt 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. | Device | spinal needle 25 gauage, spinal needle 27 gauqge |
Primary outcome
CSF sample: serum sample
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal needle in people with Anesthesia, Obestetric, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF sample: serum sample (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.