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Ropivacaine hydrochloride versus electrolytes for pain relief in women undergoing second‑trimester medical abortion after 13 weeks

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study examines pain relief for women undergoing a second trimester medical abortion. The intervention involves a local anesthetic called ropivacaine that is injected around the cervix (a technique known as a paracervical block) to numb the area, while a comparison group receives an injection of a harmless solution called placebo.

The purpose of the study is to reduce the maximum pain experienced during the procedure. Participants receive the injection shortly before the abortion is performed and then follow the standard medical abortion process. Throughout the procedure, pain levels are recorded using a visual analog scale, which is a simple line where a mark indicates how strong the pain feels, allowing researchers to compare the two groups.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Consent and enrollment

    After joining the study, you will receive information about the purpose of the trial and what will be required of you. you will be asked to sign a consent form confirming that you understand the study and agree to participate.

  2. Step 2

    Baseline assessment

    The study team will collect basic health information, measure your vital signs, and ask about any current medications or allergies. this information helps ensure your safety during the trial.

  3. Step 3

    Randomization

    You will be assigned, by a computer system, to receive either the active medication or a placebo. the assignment is concealed, so you will not know which one you receive.

  4. Step 4

    Medication administration (paracervical block)

    A single injection will be given near the cervix (this is called a paracervical block).

    If you are assigned to the active group, the injection will contain ropivacaine hydrochloride at a dose of 262 mg. the medication is delivered by infiltration, meaning it is injected into the tissue surrounding the cervix.

    If you are assigned to the placebo group, the injection will contain mannitol (an electrolyte solution) at a dose of 47 mg, also given by infiltration.

  5. Step 5

    Observation period

    After the injection, you will be asked to wait for a short period (typically a few minutes) while the medication takes effect. during this time the staff will monitor you for any immediate reactions.

  6. Step 6

    Medical abortion procedure

    You will then undergo the second‑trimester medical abortion, which follows the standard clinical protocol. the procedure may cause discomfort or pain, which the injection is intended to reduce.

  7. Step 7

    Pain assessment

    During the procedure you will be asked to rate the highest level of pain you experience using a visual analog scale (vas). the scale ranges from 0 mm (no pain) to 100 mm (worst possible pain). this rating is the primary outcome of the trial.

  8. Step 8

    Post‑procedure monitoring

    After the abortion is completed, you will remain under observation for a short time while the staff checks your vital signs and ensures that you are stable.

  9. Step 9

    Follow‑up assessment

    Later, you will be asked to return for a follow‑up visit where the study team will collect any additional information about your recovery and any side effects.

Who can join the trial?

6 criteria

  • The participant has signed a written form agreeing to join the study (written consent).
  • The participant is 18 years old or older.
  • The pregnancy involves a single, living baby (singleton viable gestation) that is at least 13 weeks old, confirmed by an imaging test (ultrasound).
  • The participant is willing to receive a local pain injection called a paracervical block (a small amount of medicine placed near the cervix to reduce pain).
  • The participant is willing to use pain medication delivered through a vein that they can control themselves (intravenous patient‑controlled analgesia).
  • The participant can understand the local language or English, or has a certified interpreter available to help.

Who cannot join the trial?

15 criteria

  • You cannot join if you are allergic to or cannot safely use paracetamol, non‑steroidal anti‑inflammatory drugs (pain relievers like ibuprofen), oxycodone hydrochloride (a strong pain medicine), mifepristone or misoprostol (medicines used for the procedure), or any local anesthetic (medicine that numbs a small area).
  • You cannot join if you are currently breastfeeding (feeding a baby with your milk).
  • You cannot join if you are taking any medication that reduces anxiety or helps you sleep, such as benzodiazepines (a type of anxiety medicine) or other sleep‑enhancing drugs.
  • You cannot join if you have severe liver problems or injury, which means your liver is not working well enough for certain medicines.
  • You cannot join if you are allergic to ropivacaine (a type of local anesthetic) or any other similar anesthetic.
  • You cannot join if you have chronic obstructive lung disease (a long‑term lung condition that makes breathing difficult), cor pulmonale (heart problems caused by lung disease), or uncontrolled asthma (asthma that is not well‑managed).
  • You cannot join if you have paralytic ileus (a condition where the intestines stop moving).
  • You cannot join if you have low blood volume (hypovolemia), which means not enough fluid in your bloodstream.
  • You cannot join if you are allergic to fentanyl or other opioids (strong pain medicines) or any ingredient in those drugs.
  • You cannot join if you have breathing problems or brain function disturbances that could be made worse by certain pain medicines.
  • You cannot join if you are using MAO‑inhibitors (a type of antidepressant that can interact badly with some pain medicines).
  • You cannot join if you are taking medicines such as fluconazole, voriconazole, cimetidine, valproate, or ritonavir, because they can interact with the study drugs.
  • You cannot join if you have a bleeding disorder or are on blood‑thinning medication that would prevent safe deep injections.
  • You cannot join if you have had a previous conization (a surgical procedure on the cervix), because it may change how the procedure works and affect pain.
  • You cannot join if you have severe emotional instability that might make it difficult for you to take part in the study.
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Investigated drugs

Ropivacaine is a local anesthetic that numbs a specific area of the body. In this study, it was injected around the cervix (a paracervical block) to reduce the pain that women may feel during a second‑trimester medical abortion. The medication works by temporarily blocking the nerves that send pain signals, helping participants experience less intense pain during the procedure.

What is already known about the treatment

  • Ropivacaine

    Ropivacaine is given by injection directly into the tissue near the cervix (paracervical infiltration) to numb the area. It is an approved local anesthetic that is widely used in surgery and pain control. It works by blocking sodium channels in nerve cells, which stops pain signals from being sent to the brain. It belongs to the class of amide‑type local anesthetics and is used mainly for regional pain relief.

  • Electrolytes (Mannitol)

    Mannitol is injected in the same way as a placebo, into the tissue near the cervix, but it does not provide pain relief. It is an established osmotic agent that is used medically to reduce pressure in the eye and to help the kidneys remove excess fluid. It works by drawing water out of cells into the bloodstream, increasing urine output. It is classified as an osmotic diuretic and is listed in medical literature as a safe, inert substance for control purposes.

Investigated diseases

Abortion - Abortion is the termination of a pregnancy before the fetus can survive outside the womb. In the second trimester, the uterine lining and embryo begin to break down, leading to cramping and bleeding. The cervix may open slightly, allowing tissue to pass through the birth canal. Hormonal changes cause the body to stop supporting the pregnancy. Over a short period, the uterus contracts and the pregnancy ends.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524599-52-03Protocol codePCBPCA 1Estimated enrolment132 patientsSponsorKarolinska Institutet

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