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NCT02574832 · ClinicalTrials.gov registry record · NA
Determination of ED90 of Intrathecal Lidocaine for Adequate Anesthesia for Elective Cervical Cerclage Surgery
A NA study, sponsored by Northwestern University.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT02574832 is a NA study that was terminated before completion, run by Northwestern University. The registered enrollment target is 2 participants.
The verdict
NCT02574832, a NA study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
Cervical incompetence complicates approximately 1 in 500 pregnancies . Those women with cervical incompetence are at risk for second trimester spontaneous abortion and preterm labor. Cervical cerclage reduces these risks but must be performed under general or neuraxial anesthesia. Some anesthesiologists prefer neuraxial anesthesia, as it reduces fetal exposure to medications and avoids the risks associated with loss of maternal airway reflexes under general anesthesia. Spinal anesthesia, in particular, has the added advantage of being technically simple while still providing a rapid, dense sensory block. For cerclage placement, patients require a sensory block from the T10 to S4 dermatome in order to cover sensation from the cervix as well as the vagina and perineum. Patients presenting for cerclage under spinal anesthesia pose a dosing challenge given the physiologic changes associated with pregnancy. As women progress with their pregnancy, they require lower doses of intrathecal local anesthetic to achieve similar block level. Multiple studies have demonstrated that these changes start during the second trimester. Inadequate sensory coverage with a spinal anesthetic typically necessitates conversion to general anesthesia, causing additional time wasted and added risk to the patient and fetus. Anecdotally, this is the reason why some anesthesiologists choose general anesthesia for patients undergoing cerclage over a spinal anesthetic. As there is currently no literature determining the correct dosage for these patients, we propose a dose-response study to determine the ED90 of intrathecal lidocaine for adequate anesthesia for elective cervical cerclage placement.The findings of this study will help determine the minimum dose of intrathecal lidocaine necessary to provide adequate spinal anesthesia for cervical cerclage for 90% of women. This will help decrease the frequency of inadequate anesthesia for cervical cerclage.
Interventions
- DRUG Lidocaine Administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02574832
The ClinicalTrials.gov registry entry for NCT02574832 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lidocaine Administration is the first listed.
NCT02574832 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02574832 about?
NCT02574832 is a clinical study titled "Determination of ED90 of Intrathecal Lidocaine for Adequate Anesthesia for Elective Cervical Cerclage Surgery". Cervical incompetence complicates approximately 1 in 500 pregnancies . Those women with cervical incompetence are at risk for second trimester spontaneous abortion and preterm labor. Cervical cerclage reduces these risks but must be performed under general or neuraxial anesthesia. Some anesthesiolog...
What is the current status of trial NCT02574832?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2015-10. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02574832?
The interventions under investigation include: Lidocaine Administration (DRUG).
Who is sponsoring clinical trial NCT02574832?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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