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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2022-12-31

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.

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lidocaine-prilocaine cream

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

Group Type EXPERIMENTAL

Lidocaine-Prilocaine Cream

Intervention Type DRUG

10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine

1% Lidocaine Paracervical Block

Intervention Type DRUG

Paracervical block of 10ml of 1% lidocaine

Placebo cream (pain lucubrating gel)

5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe

Group Type PLACEBO_COMPARATOR

Placebo Cream

Intervention Type DRUG

10ml of vaginally self-administered placebo cream

1% Lidocaine Paracervical Block

Intervention Type DRUG

Paracervical block of 10ml of 1% lidocaine

Interventions

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Lidocaine-Prilocaine Cream

10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine

Intervention Type DRUG

Placebo Cream

10ml of vaginally self-administered placebo cream

Intervention Type DRUG

1% Lidocaine Paracervical Block

Paracervical block of 10ml of 1% lidocaine

Intervention Type DRUG

Other Intervention Names

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EMLA

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes