Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT07487246
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketorolac — DRUG
    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.
  • oral ibuprofen — DRUG
    Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.
  • Placebo — DRUG
    Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.
  • Lidocaine HCl 1% — DRUG
    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.
  • Saline — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Treatment Group
    Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac
  • Active Comparator: Standard Treatment
    Oral ibuprofen with plain 1% lidocaine paracervical block

Primary Outcome Measure

Pain post-osmotic dilator insertion [ Time Frame: 5 minutes and 30 minutes post-dilator insertion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-

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By research site
Rush University Medical Center· Chicago, IL

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