The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies

Study Overview
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Brief Summary
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When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures. Women being treated at the Women & Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure. The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.

Conditions
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Nonviable Pregnancy

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at the Women and Infants Triage/Women's Emergency Department Vital signs are stable Ages 18 and older Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy Estimated gestational age up to 10 weeks Undergoing MVA at the Women and Infants Triage/Women's Emergency Department Able to read English or Spanish Able to give informed consent for involvement in the study Exclusion Criteria: Allergic to lidocaine, iodine or betadine Known sensitivity to any component of the lidocaine or placebo gel. In acute distress Unable to give informed consent Unable to read English or Spanish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo gel<br>Placebo gel applied topically to the cervix | Drug: Placebo gel<br>* odorless, colorless gel will be used as a placebo<br>* Other names: KY Jelly;|
| Experimental: Lidocaine gel<br>2% lidocaine gel applied topically to the cervix | Drug: Lidocaine<br>* 2% Lidocaine gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during intracervical block | Pain on visual analogue scale | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during tenaculum placement | Pain on visual analogue scale | immediate | 
| Pain during cervical dilation | Pain on visual analogue scale | immediate | 
| Pain during uterine aspiration | Pain on visual analogue scale | immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manual vacuum aspiration, missed abortion, incomplete abortion, nonviable pregnancy, topical lidocaine