What this study is
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.
What's being tested
- Ketorolac
Intervention · 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
Intervention · DRUG
Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.
- Placebo
Intervention · DRUG
Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.
- Lidocaine HCl 1%
Intervention · 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
Intervention · 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
- Official title
- Effects of Paracervical Block With Combined Ketorolac and Lidocaine on Perceived Pain in Osmotic Dilator Placement for Abortion, a Randomized Controlled Trial
- Sponsor
- Rush University Medical Center
- Conditions
- Pain Management · Abortion · Second Trimester Abortion · Dilation and Evacuation
- Enrolling
- 76 people
- Starts
- 2026-06-29
- Est. completion
- 2027-04-30
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join 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 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openRush University Medical Center
Chicago, Illinois, United States
Recruiting
Study team
Sponsor
Rush University Medical Center
Study ID 25111201-IRB01
Principal investigator
Sadia MA Haider, MD, MPH
Rush University Medical Center
Principal investigator
Kathryn Crofton, MD
Rush University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.