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

NCT02574832 | Terminated Results

• 1 other identifier: STU0020134
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Surgery; Pain

Keywords

Pain; Surgery; Pregnancy; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Spinal Lidocaine Administration

EXPERIMENTAL

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

Interventions

Lidocaine Administration DRUG

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

Spinal Lidocaine Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• 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.

  PMID: 25103960 BACKGROUND

• 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. doi: 10.1093/bja/74.4.384.

  PMID: 7734254 BACKGROUND

• 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.

  PMID: 20006255 BACKGROUND

• 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.

  PMID: 24228145 BACKGROUND

• Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a precis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. doi: 10.1097/01.anes.0000267514.42592.2a.

  PMID: 17585226 BACKGROUND

• 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. doi: 10.1007/BF03021057.

  PMID: 12734154 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Study ended early because of procedure changes.

Results Point of Contact

• Title: Paloma Toledo, M.D.
• Organization: Northwerstern University

p-toledo@northwestern.edu

312-472-3585

Study Officials

• Paloma Toledo, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Anesthesiology

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 14, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 20, 2018
• Results First Posted: December 8, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)