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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03508804

Enrollment

Registered

2018-04-26

Start date

2020-12-31

Completion date

2022-12-31

Last updated

2018-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

surgical abortion, cervical anesthesia, pain control

Brief summary

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

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.

Interventions

DRUGLidocaine-Prilocaine Cream

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

DRUGPlacebo Cream

10ml of vaginally self-administered placebo cream

DRUG1% Lidocaine Paracervical Block

Paracervical block of 10ml of 1% lidocaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026