Determination of ED90 of Intrathecal Lidocaine for Adequate Anesthesia for Elective Cervical Cerclage Surgery

Pain Clinical Trial

Official title:

Determination of ED90 of Intrathecal Lidocaine for Adequate Anesthesia for Elective Cervical Cerclage Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02574832
• Other study ID #: STU0020134
• Status: Terminated
• Phase: N/A
• First received: October 8, 2015
• Last updated: January 22, 2018
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient who is at least 18 years old

• ASA physical class I or II

• BMI <40 kg/m2,

• Presents for elective cervical cerclage during their first or second trimester of pregnancy will be eligible to participate.

Exclusion Criteria:

• Any patient who is not a candidate for neuraxial anesthesia (including coagulopathy,

• Local skin infection, uncorrected hypovolemia)

• Allergy to lidocaine or fentanyl

• Chronic opioid user

• History of failed neuraxial anesthesia or analgesia,

• Had prior spine surgery

• Can not assume a sitting position for spinal anesthesia due to risk of amniotic membrane rupture

Related Conditions & MeSH terms

• Pain
• Pregnancy
• Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9. — View Citation

Hirabayashi Y, Shimizu R, Saitoh K, Fukuda H. Spread of subarachnoid hyperbaric amethocaine in pregnant women. Br J Anaesth. 1995 Apr;74(4):384-6. — View Citation

Ioscovich A, Popov A, Gimelfarb Y, Gozal Y, Orbach-Zinger S, Shapiro J, Ginosar Y. Anesthetic management of prophylactic cervical cerclage: a retrospective multicenter cohort study. Arch Gynecol Obstet. 2015 Mar;291(3):509-12. doi: 10.1007/s00404-014-3391-5. Epub 2014 Aug 8. — View Citation

Lee GY, Kim CH, Chung RK, Han JI, Kim DY. Spread of subarachnoid sensory block with hyperbaric bupivacaine in second trimester of pregnancy. J Clin Anesth. 2009 Nov;21(7):482-5. doi: 10.1016/j.jclinane.2008.12.018. — View Citation

Lee MH, Son HJ, Lee SH, Lee JH, Chung MH, Choi YR, Choi EM. Comparison of spread of subarachnoid sensory block and incidence of hypotension in early and late second trimester of pregnancy. Korean J Anesthesiol. 2013 Oct;65(4):322-6. doi: 10.4097/kjae.2013.65.4.322. Epub 2013 Oct 24. — View Citation

Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a précis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 minutes after drug administration