Intrauterine Lidocaine for Laminaria

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Abortion, Induced Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intrauterine Lidocaine

The experimental arm will receive 100mg lidocaine (5mL of 2% concentration) instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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

Intrauterine Saline

Placebo arm will receive 5mL of normal saline instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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

Interventions

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Lidocaine

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

Intervention Type DRUG

Normal Saline

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No