An interventional study of Lidocaine Administration in Pregnancy, Surgery and Pain, sponsored by Northwestern University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-20.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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.
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This study's enrollment of 2 is below the median of 70 across 2,101 interventional studies indexed under Pain.
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Spinal anesthesia will be induced with isobaric 2% lidocaine and 15 μg fentanyl. The study lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). If the lidocaine dose provides an unsatisfactory anesthetic, the case will be categorized as a failure. After a failed case, the next participant will receive a lidocaine dose increased by 4 mg. If the lidocaine dose provides satisfactory anesthesia, the next participant's lidocaine dose will determined by a biased allocation method with a 90% chance of maintaining the dose and a 10% chance of decreasing the dose by 4 mg.
Drug: Lidocaine Administration
The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia.
Also known as: Lidocaine 2 % plus 15 μg fentanyl
Time to T 10 Level
Elapsed time in minutes to achieve T 10 level of anesthesia. Assessed by the anesthesia care provider using crushed ice. T 10 level is numbness up to the level of the belly button.
Time frame: 20 minutes after drug administration
| Milestone | Spinal Lidocaine Administration |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
Elapsed time in minutes to achieve T 10 level of anesthesia. Assessed by the anesthesia care provider using crushed ice. T 10 level is numbness up to the level of the belly button.
| Minutes | Spinal Lidocaine Administration |
|---|---|
| Time to T 10 Level | 12.5 (9 to 16) |
Collected over 24 hours after cerclage. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spinal Lidocaine Administration | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Spinal Lidocaine Administration |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Age, Continuous(Years) | Spinal Lidocaine Administration |
|---|---|
| Mean | 34 (30 to 38) |
| Sex: Female, Male(Participants) | Spinal Lidocaine Administration |
|---|---|
| Female | 2 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Spinal Lidocaine Administration |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(count of participants) | Spinal Lidocaine Administration |
|---|---|
| United States | 2 |
| Height(centimeters) | Spinal Lidocaine Administration |
|---|---|
| Mean | 163.5 (162 to 165) |
| Weight(Kilograms) | Spinal Lidocaine Administration |
|---|---|
| Mean | 54.1 (48.1 to 60.1) |
| Number of live births(Number of live births) | Spinal Lidocaine Administration |
|---|---|
| Mean | 1 (1 to 1) |
6 further baseline measures are reported on the registry.
Plan to share: No
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