Intrauterine Lidocaine for Laminaria

Intrauterine Lidocaine for Pain Control During Laminaria Insertion Prior to Dilation & Evacuation (D&E)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01541293

Enrollment

Registered

2012-02-29

Start date

2012-09-30

Completion date

2013-10-31

Last updated

2014-05-14

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

Conditions

Abortion, Induced, Pain Management

Keywords

Abortion, Induced, Laminaria, Pain management, Cervical preparation, Dilation and Evacuation

Brief summary

This is a study to investigate whether instilling a small amount of liquid lidocaine into the uterus will decrease pain felt by women during laminaria insertions done for cervical dilation prior to second trimester abortion. The investigators hypothesize that women who receive intrauterine lidocaine in addition to a paracervical block will experience less pain than women who receive only a paracervical block.

Interventions

DRUGLidocaine

100mg of liquid lidocaine, single dose, instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.

DRUGNormal Saline

5mL of normal saline, instilled into the uterus via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Can sign informed consent * Healthy pregnant females * Weight over 45kg * Seeking abortion by dilation and evacuation in the second trimester of pregnancy * Gestational age 14-24 weeks confirmed by clinic ultrasound

Exclusion criteria

* Known allergy or previous reaction to lidocaine, bupivicaine or other anesthetic agent * Known allergy or previous reaction to ibuprofen or other NSAID

Design outcomes

Primary

Measure	Time frame
Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale	Immediately following laminaria insertion

Secondary

Measure	Time frame
Patient self-report of maximum recalled pain during interval between laminaria insertion and abortion procedure, scored on a 100mm Visual Analog Scale	24-48 hours after laminaria insertion

Countries

United States

Outcome results

None listed

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