Paracervical Block With Ketorolac and Lidocaine for Osmotic Dilator Placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 trial compares pain control strategies used for cervical preparation with osmotic dilators prior to a second-trimester abortion. Participants receive either ketorolac combined with lidocaine, or alternative controls such as ibuprofen, placebo, or saline in a paracervical block approach. The aim is to determine if the ketorolac-lidocaine combination reduces pain during dilator placement. Eligible participants are adults seeking outpatient abortion services at Rush University Medical Center, within 16 to 23 weeks gestation, who require osmotic dilators one day before the procedure. The study builds on prior research of paracervical injections in earlier gestations and explores a new application for osmotic dilator insertion.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Sadia MA Haider, MD, MPH — Rush University Medical Center
• Study coordinator: Cristina MA Barkowski, MSW, DrPH(s)
• Email: cristina_m_barkowski@rush.edu
• Phone: 312-942-6382

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.