Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement (PCB-KinD)

Effects of Paracervical Block With Combined Ketorolac and Lidocaine on Perceived Pain in Osmotic Dilator Placement for Abortion, a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management; Abortion; Second Trimester Abortion; Dilation and Evacuation
• Intervention / Treatment: Drug: Ketorolac; Drug: Placebo; Drug: Lidocaine HCl 1%; Drug: oral ibuprofen; Drug: Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cristina MA Barkowski, MSW, DrPH(s); Phone Number: 312-942-6382; Email: cristina_m_barkowski@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

Age >/= 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 intrauterine pregnancy with an estimated gestational age of 16+0-23+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

Exclusion criteria:

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 PO benzodiazepine or 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) Require transabdominal/transvaginal injection for induced fetal demise prior to abortion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Treatment Group; Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac	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: 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.
Active Comparator: Standard Treatment; Oral ibuprofen with plain 1% lidocaine paracervical block	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: oral ibuprofen; Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain post-osmotic dilator insertion	i. Mean difference between arms in NRS immediately after insertion of osmotic dilators	After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain with maintenance of osmotic dilators	Mean difference between arms in NRS at 5 minutes (in clinic), 30 minutes and 1, 2, 4, 6 hours (all by text-message) after insertion of osmotic dilators.	5 minutes to 6 hours after insertion of osmotic dilators
Patient Satisfaction	Mean difference in satisfaction measured with 100mm VAS.	5 minutes after insertion of osmotic dilators
Cervical dilators (exploratory)	Cervical dilation assessed with digital exam after removal of osmotic dilators at time of D&E; mechanical dilation performed during D&E (yes/no)	Intraoperatively at start of D&E

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Sadia MA Haider, MD, MPH, Rush University Medical Center; Principal Investigator: Kathryn Crofton, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 29, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; ketorolac; paracervical block; osmotic dilators
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Anatomical; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Dilatation, Pathologic; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Indomethacin; Indoles; Inorganic Chemicals; Chlorine Compounds; Acids, Carbocyclic; Sodium Compounds; Phenylpropionates; Chlorides; Hydrochloric Acid; Ketorolac; Ibuprofen; Sodium Chloride
• Other Study ID Numbers: 25111201-IRB01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No