Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation

Study Overview
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Brief Summary
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To examine whether application of lidocaine spray in cervical preparation for second trimester dilatation and evacuation alleviates pain and is superior to current protocol of preparation without analgesia and superior to placebo. a double- blind, randomized, placebo- controlled trial, performed at a single tertiary medical center. Eligible participants aged 18 and older and about to undergo dilation & evacuation of the uterus between 12 to 24 weeks of gestation. Participants will be randomized using computer generated allocation to receive 10% Xylocaine (lidocaine group) spray or normal saline 0.9% (placebo group), applied identically topically to the endocervix and ectocervix before laminaria insertion. The primary outcome will be the participant's reported pain score immediately after the first laminaria was inserted as measured on a 10 cm visual analog scale (VAS). Secondary outcomes wiil be reported pain scores at speculum removal, 15 minutes after speculum insertion and immediately before the D&E procedure.

Official Title
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Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation

Conditions
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Pain Alleviation, Dilatation and Evacuation, Laminaria Placement

Intervention / Treatment
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* Drug: Lidocaine
* Other: placebo comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Informed consent Women with a gestational age of 12-24 weeks by last menstrual period. Exclusion Criteria: • CRL assesed by ultrasound as <10 weeks Clinical Uterine size >24 weeks Fetus Bi Parietal Diameter > 50 mm Known amide allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine spray group<br> | Drug: Lidocaine<br>* will local application of lidocaine to the cervix alleviate pain of laminaria insertion<br>|
| Placebo Comparator: placebo arm<br> | Other: placebo comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain immediately after inserton of first laminaria | Women's reported VAS pain score immediately after the insertion of the first laminaria. | immediately after first laminaria insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported pain afer speculum removal, 15 minutes after speculum inserion and before D&E | Reported VAS pain at speculum removal, 15 minutes after speculum insertion and before D&E | After speculum removal, 15 minutes after speculum insertion and before D&E | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine, laminaria, dilatation and evacuation, pain