CompletedPhase 4

Paracervical Block for Pain Control in First Trimester Abortion

United States121 participantsStarted 2010-04

Plain-language summary

Many woman undergoing a surgical abortion receive a paracervical nerve block for pain reduction, in which lidocaine (a numbing medication) is injected around the cervix. These injections numb the cervix and possibly the lower part of the uterus. However, the injection can be uncomfortable and it is not well known whether it is effective in reducing pain. The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that paracervical block might have on that pain.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 18 years or older * Voluntarily requesting pregnancy termination * Ultrasound confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age * Good general health * English or Spanish speaking * Be able and willing to sign an informed consent and agree to terms of the study Exclusion Criteria: * Gestational ages over 11 0/7 weeks, due to routine misoprostol use at our institutions * Incomplete abortion * Required or requested narcotics or IV sedation (prior to randomization) * Patients who refuse Ibuprofen and paracervical blocks * Contraindications or allergies to lidocaine, ibuprofen or ativan * Significant physical or mental health condition * Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease * Patients with known hepatic disease * Women, who in the opinion of the investigator are not suitable for the study protocol

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain reported with cervical dilation

Timeframe: 1 Year

Trial details

NCT IDNCT01094366

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-10

View on ClinicalTrials.gov More Legal Abortion With Complication trials