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

Stanford University

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Pain

Interventions

Lidocaine-Prilocaine CreamDRUG

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

Placebo CreamDRUG

10ml of vaginally self-administered placebo cream

1% Lidocaine Paracervical BlockDRUG

Paracervical block of 10ml of 1% lidocaine

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Stanford Health Care

Stanford, California, United States

Outcomes

Primary Outcomes

Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation

Time frame: Intraoperative; Immediately following cervical dilation

Data from ClinicalTrials.gov

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