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

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02574832
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy; Surgery; Pain	Drug: Lidocaine Administration	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Determination of ED90 of Intrathecal Lidocaine for Adequate Anesthesia for Elective Cervical Cerclage Surgery
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Spinal Lidocaine Administration 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.; Other Names: Lidocaine 2 % plus 15 μg fentanyl

Outcome Measures

Primary Outcome Measures

1. Time to T 10 Level [20 minutes after drug administration]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prentice Women's Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Paloma Toledo, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Paloma Toledo, Assistant Professor in Anesthesiology, Northwestern University
• ClinicalTrials.gov Identifier: NCT02574832
• Other Study ID Numbers: STU0020134
• First Posted: Oct 14, 2015
• Last Update Posted: Feb 20, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Paloma Toledo, Assistant Professor in Anesthesiology, Northwestern University: Pain; Surgery; Pregnancy; Anesthesia
• Additional relevant MeSH terms: Lidocaine; Fentanyl

Study Results

Participant Flow

Arm/Group Title	Spinal Lidocaine Administration
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Spinal Lidocaine Administration
Arm/Group Description	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. 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.
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	34
Sex: Female, Male (Count of Participants)
Female	2 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	2 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (count of participants) [Number]
United States	2 100%
Height (centimeters) [Mean (Full Range) ]
Mean (Full Range) [centimeters]	163.5
Weight (Kilograms) [Mean (Full Range) ]
Mean (Full Range) [Kilograms]	54.1
Number of live births (Number of live births) [Mean (Full Range) ]
Mean (Full Range) [Number of live births]	1
Indication for cerclage (Count of Participants)
Cervical Incompetence	1 50%
History of previous loss	1 50%
Baseline heart rate (Beats per minute) [Mean (Full Range) ]
Mean (Full Range) [Beats per minute]	73
Baseline systolic blood pressure (millimeters of mercury) [Mean (Full Range) ]
Mean (Full Range) [millimeters of mercury]	111.5
Baseline diastolic blood pressure (millimeters of mercury) [Mean (Full Range) ]
Mean (Full Range) [millimeters of mercury]	60
Estimated Gestational Age (weeks) [Mean (Full Range) ]
Mean (Full Range) [weeks]	13.3
Number of times pregnant (Number of pregnancies) [Mean (Full Range) ]
Mean (Full Range) [Number of pregnancies]	4

Outcome Measures

1. Primary Outcome

Title	Time to T 10 Level
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Lidocaine Administration
Arm/Group Description	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. 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.
Measure Participants	2
Mean (Full Range) [Minutes]	12.5

Adverse Events

Time Frame	24 hours after cerclage
Arm/Group Title	Spinal Lidocaine Administration
Arm/Group Description	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. 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.
All Cause Mortality
	Spinal Lidocaine Administration
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Spinal Lidocaine Administration
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Spinal Lidocaine Administration
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

Study ended early because of procedure changes.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.