Paracervical Block for Pain Control With Osmotic Dilator Placement

Summary

Cervical dilators are frequently used for preparation prior to second trimester surgical abortion. While their use decreases complications associated with surgical abortion, their placement is often uncomfortable for the patient. Currently there are no proven methods for reducing pain during osmotic dilator placement. The use of numbing medication around the cervix (paracervical block) may decrease this placement pain.

Conditions

• Abortion Late
• Pain

Interventions

PROCEDURE

Local anesthetic for tenaculum placement

2 mL of buffered Lidocaine injected superficially at anterior lip of cervix in 12 o'clock position Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate

PROCEDURE

Sham

Over 60 seconds, without moving the tenaculum, a capped needle gently touches the vaginal sidewall at the level of the external os at 4 and 8 o'clock positions

PROCEDURE

Paracervical Block

18 mL of buffered Lidocaine is slowly injected into the vaginal fornices and equally distributed at 4 and 8 o'clock. The injection is continuous from superficial to deep (3cm) to superficial (injecting with insertion and withdrawal) Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate

PROCEDURE

Dilator Placement

Osmotic dilators will be placed in the usual fashion with a combination of Dilapan-S and laminaria per clinician preference Drugs: Dilapan-S is a hygroscopic cervical dilator made of a patented hydrogel called AQUACRYL. It is a rigid hydrophilic stick that increases in volume by absorbing fluids and comfortably dilating the cervix. Laminaria is an herbal medicine used to induce labor and abortion. The dried stem of Laminaria mechanically dilates the cervical opening by absorbing water and swelling to several times its original diameter.

BEHAVIORAL

Post-procedural assessment

15 minutes after procedure, subjects will complete a questionnaire that collects information about pain, negative symptoms, and assessment of how effective their pain management was.

DRUG

Preprocedural pain control

800 mg Ibuprofen taken before dilator placement

Sponsors & Collaborators

• Planned Parenthood Federation of America

  collaborator OTHER

• University of California, San Diego

  lead OTHER

Principal Investigators

• Lisa Bayer, MD MPH · UCSD Department of Reproductive Medicine

• Sheila Mody, MD MPH · UCSD Department of Reproductive Medicine

• Kelly Culwell, MD MPH · Planned Parenthood of the Pacific Southwest

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-04-02

Primary Completion

2015-08-25

Completion

2015-08-25

Countries

• United States

Study Locations