Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02097017

Enrollment

134

Registered

2014-03-26

Start date

2016-07-01

Completion date

2018-08-01

Last updated

2020-05-27

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

Conditions

Dilatation and Evacuation, Laminaria Placement, Pain Alleviation

Keywords

lidocaine, laminaria, dilatation and evacuation, pain

Brief summary

To examine whether application of lidocaine spray in cervical preparation for second trimester dilatation and evacuation alleviates pain and is superior to current protocol of preparation without analgesia and superior to placebo. a double- blind, randomized, placebo- controlled trial, performed at a single tertiary medical center. Eligible participants aged 18 and older and about to undergo dilation & evacuation of the uterus between 12 to 24 weeks of gestation. Participants will be randomized using computer generated allocation to receive 10% Xylocaine (lidocaine group) spray or normal saline 0.9% (placebo group), applied identically topically to the endocervix and ectocervix before laminaria insertion. The primary outcome will be the participant's reported pain score immediately after the first laminaria was inserted as measured on a 10 cm visual analog scale (VAS). Secondary outcomes wiil be reported pain scores at speculum removal, 15 minutes after speculum insertion and immediately before the D&E procedure.

Interventions

DRUGLidocaine

will local application of lidocaine to the cervix alleviate pain of laminaria insertion

OTHERplacebo comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* • Informed consent * Women with a gestational age of 12-24 weeks by last menstrual period.

Exclusion criteria

* • CRL assesed by ultrasound as \<10 weeks * Clinical Uterine size \>24 weeks * Fetus Bi Parietal Diameter \> 50 mm * Known amide allergy

Design outcomes

Primary

Measure	Time frame	Description
Pain immediately after inserton of first laminaria	immediately after first laminaria insertion	Women's reported VAS pain score immediately after the insertion of the first laminaria.

Secondary

Measure	Time frame	Description
Reported pain afer speculum removal, 15 minutes after speculum inserion and before D&E	After speculum removal, 15 minutes after speculum insertion and before D&E	Reported VAS pain at speculum removal, 15 minutes after speculum insertion and before D&E

Countries

Israel

Outcome results

None listed

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