AuthorisedTherapeutic confirmatory (Phase III)Interventional

Paracervical block with ropivacaine for pain relief in second trimester medical abortion - a double blind placebo controlled randomized trial

Having a medical abortion during the second trimester (after 12 weeks of pregnancy) can cause strong, painful cramps. Doctors are searching for better ways to keep patients comfortable during this process. This clinical trial looks at a pain-relief method known as a paracervical block. This involves a small injection of a local numbing medicine, called ropivacaine, placed near the cervix (the neck of the womb). In this study, half of the women will receive the numbing injection, while the other half will receive an inactive salt-water solution (a placebo). Neither the patients nor their doctors will know who gets which injection until the trial ends. Patients will rate their pain on a simple scale during the procedure. The goal is to see whether this numbing injection significantly reduces pain, helping to improve comfort and care for women in the future.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Karolinska Institutet

Enrolment target

132

Start

17 Jul 2026

abortion

What is this study about?

A second-trimester medical abortion involves taking medicines to end a pregnancy between roughly 13 and 24 weeks. While this is a safe and common procedure, the medications cause the womb to contract and open, which can lead to significant cramping and pain. Finding reliable, effective ways to ease this pain is an important goal for women's healthcare.

This trial investigates a technique called a paracervical block using ropivacaine. Ropivacaine is a well-established local anaesthetic that temporarily numbs nerves. In this procedure, the medicine is injected around the cervix (the opening to the womb) to block pain signals before they travel to the brain.

To see if the injection genuinely makes a difference, researchers are comparing ropivacaine against a placebo (an inactive salt-water injection). This is a 'double-blind' trial, meaning neither the participants nor the clinical staff know who receives the anaesthetic and who receives the placebo. This helps make sure the results are fair and unbiased.

During the procedure, women will be asked to score their pain using a standard measurement scale. By understanding how well this numbing block works, healthcare teams hope to update treatment guidelines and provide gentler, more comfortable care for women having abortions in hospitals and clinics.

Key takeaways

The trial tests a local numbing injection (ropivacaine) to reduce pain during second-trimester medical abortions.
Participants are randomly assigned to receive either the numbing injection or an inactive salt-water placebo.
Standard pain medications are always available if you feel uncomfortable at any point.
Taking part happens during your regular appointment and does not require extra hospital visits.
Participation is entirely voluntary, and choosing not to take part will not affect your routine care.

Who may be eligible?

This study is open to women aged 18 and over who have chosen to have a medical abortion in the second trimester of pregnancy.

To take part, you must be in good general health for this procedure and able to receive local anaesthetics safely. Women who have had allergic reactions to numbing medicines like ropivacaine in the past will not be able to join.

Your healthcare team will review your full medical history and discuss the study with you. They will ensure that taking part is safe for your individual health circumstances before you decide whether to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a woman aged 18 or older.
I am having a medical abortion in the second trimester.
I do not have a known allergy to local anaesthetics like ropivacaine.
I am able to give informed consent to take part in clinical research.

Answer every question to see your result.

What does participation involve?

If you take part, your participation will happen during your scheduled clinic or hospital visit for the abortion. Alongside your standard care, a doctor will give you the study injection (either ropivacaine or salt water) near the cervix. During and shortly after the procedure, you will be asked to rate your pain on a simple sliding scale from 'no pain' to 'worst pain imaginable'. The team will also monitor your heart rate, blood pressure, and recovery. The study does not require extra hospital visits; it takes place during your standard appointment, with follow-up checks finishing before you are discharged home.

Potential risks and benefits

If you receive the active medicine, you may experience less pain during the abortion, though this cannot be guaranteed. If you receive the placebo, you may not get this benefit, but standard pain relief medicines will always be available if you need them. The risks include brief discomfort or stinging where the injection is given, and minor local anaesthetic side effects such as temporary dizziness or tingling. Joining the study is completely your choice, and you can withdraw at any time without it affecting your medical care or your relationship with your healthcare team.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

Will I still receive pain relief if I get the placebo?

Yes. Your comfort remains a top priority. Standard pain medicines will still be provided as part of your routine care whenever you need them.

What is a paracervical block?

It is an injection of local anaesthetic given around the cervix (the neck of the womb) to temporarily numb the area and block pain signals.

Can I choose whether I receive the medicine or the placebo?

No. A computer randomly decides which injection you receive to ensure the study results are fair and scientifically accurate.

Does taking part change the abortion procedure itself?

No. The abortion medications and the main clinical process remain exactly the same as standard clinic care.

What happens if I change my mind about taking part?

You can change your mind and leave the trial at any point. Your decision will not change the quality of your care in any way.