Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement

Summary

The purpose of this study is to improve pain management for participantswho need osmotic dilators for cervical preparation the day before their second trimester abortion procedure. Osmotic dilators are sticks that are inserted into the cervix. They soak up fluid and expand overnight, gently opening the cervix. We are studying an injection of ketorolac (a liquid anti-inflammatory medication similar to ibuprofen) combined with lidocaine (a liquid numbing medication), which is injected vaginally to the area surrounding the cervix. Ketorolac is approved by the U.S. Food and Drug Administration (FDA) for intravenous (IV) and intramuscular injection and has been studied as a paracervical injection for participants having first trimester abortion procedures in the office. It has not previously been studied for osmotic dilator insertion.

Conditions

• Pain Management
• Abortion
• Second Trimester Abortion
• Dilation and Evacuation

Interventions

DRUG

Ketorolac

Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement. Immediately prior to placement of osmotic dilators, a 1% lidocaine + ketorolac paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL ketorolac (30mg) will be administered.

DRUG

oral ibuprofen

Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.

DRUG

Placebo

Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.

DRUG

Lidocaine HCl 1%

Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed in the following fashion: Two milliliters of the analgesic mixture will be placed at the tenaculum site intracervically. After the tenaculum is placed, the remaining 18 mL of the analgesic mixture will be administered at 4 and 8 o'clock at the cervicovaginal reflection.

DRUG

Saline

Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed.

Sponsors & Collaborators

• Rush University Medical Center

  lead OTHER

Principal Investigators

• Sadia MA Haider, MD, MPH · Rush University Medical Center

• Kathryn Crofton, MD · Rush University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2027-04-30

Completion

2027-04-30

FDA Drug

Yes

Countries

• United States

Study Locations