Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement

NCT07487246 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25111201-IRB01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

randomized controlled trial; osmotic dilators; ketorolac; paracervical block

Outcome Measures

Primary Outcomes (1)

• Pain post-osmotic dilator insertion

  i. Median change in NRS from baseline (Time A) to 5 minutes post osmotic dilator insertion (Time D) ii. Median change in NRS from baseline (Time A) to 30 minutes post osmotic dilator insertion (Time E)

  5 minutes and 30 minutes post-dilator insertion

Secondary Outcomes (3)

• Pain with maintenance of osmotic dilators

  Over 24 hours post-insertion

• Patient Satisfaction

  24 hours post-dilator insertion

• Provider interpretation of pain

  Immediately after dilator insertion

Study Arms (2)

Intervention Treatment Group

EXPERIMENTAL

Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac

Drug: Ketorolac; Drug: Placebo; Drug: Lidocaine HCl 1%

Standard Treatment

ACTIVE COMPARATOR

Oral ibuprofen with plain 1% lidocaine paracervical block

Drug: oral ibuprofen; Drug: Lidocaine HCl 1%; Drug: Saline

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.

Intervention Treatment Group

oral ibuprofen DRUG

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

Standard Treatment

Placebo DRUG

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

Intervention Treatment Group

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.

Intervention Treatment Group; Standard Treatment

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.

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of at least 18 years
• English or Spanish speaking
• Ability and willingness to sign the informed consent
• Ability and willingness to comply with the terms of the study including possessing active cell phone with text messaging capabilities
• Voluntary request for pregnancy termination
• Ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age of 16+0-24+6 weeks gestational age
• Require osmotic dilator placement one day prior to procedural abortion according to institutional protocol
• Seeking outpatient abortion services at Rush University Medical Center

You may not qualify if:

• Have taken NSAIDs less than 6 hours prior to their clinic visit
• Contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria
• Allergic reaction or sensitivity to NSAIDs
• History of peptic ulcer or gastrointestinal bleed, history of gastric bypass (RYGB) or recent history in last 6 months of gastric sleeve; history of inflammatory bowel disease (Ulcerative colitis, Crohn's disease)
• Uncontrolled hypertension, heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease
• Acute renal failure or chronic renal disease
• Chronic liver disease
• History of bleeding diathesis
• Untreated acute cervicitis or pelvic inflammatory disease
• Require or request IV sedation for placement of osmotic dilators
• Require more than 1 day of osmotic dilators
• Chronic or current narcotic use
• Current recreational drug use (excluding cannabis)

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Agnosia; Dilatation, Pathologic

Interventions

Ketorolac; Ibuprofen; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sadia MA Haider, MD, MPH

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Kathryn Crofton, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina MA Barkowski, MSW, DrPH(s)

CONTACT

312-942-6382; cristina_m_barkowski@rush.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)