Lidocaine-Prilocaine Cream in Conjunction With Paracervical Block for Pain With Abortion

Study Overview
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Brief Summary
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The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall.

Detailed Description
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This is a superiority, double-blind randomized controlled trail of women ages 18 and older presenting for first-trimester surgical abortion. The lidocaine-prilocaine cream will be used in the experimental group in conjunction with a paracervical block, whereas plain lubricating gel will be used in conjunction with a paracervical block for the placebo, control group.

Official Title
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Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine-Prilocaine Cream
* Drug: Placebo Cream
* Drug: 1% Lidocaine Paracervical Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: surgical abortion patient at 5 0/7 to 11 6/7 weeks gestational age; English or Spanish speaking; ability to give informed consent Exclusion Criteria: pre-operative use of misoprostol; allergy to study medications (lidocaine, prilocaine, versed, fentanyl); known uterine anomaly; prior cervical surgery

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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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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine-prilocaine cream<br>5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the lidocaine-prilocaine cream vaginally using a syringe | Drug: Lidocaine-Prilocaine Cream<br>* 10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine<br>* Other names: EMLA;Drug: 1% Lidocaine Paracervical Block<br>* Paracervical block of 10ml of 1% lidocaine<br>|
| Placebo Comparator: Placebo cream (pain lucubrating gel)<br>5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe | Drug: Placebo Cream<br>* 10ml of vaginally self-administered placebo cream<br>Drug: 1% Lidocaine Paracervical Block<br>* Paracervical block of 10ml of 1% lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation |  | Intraoperative; Immediately following cervical dilation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical abortion, cervical anesthesia, pain control