Ropivacaine Paracervical Block for Pain Reduction in Second‑Trimester Medical Abortion: A Double‑Blind Placebo‑Controlled Randomized Trial

The primary objective is to evaluate whether paracervical infiltration of ropivacaine reduces the maximum pain intensity experienced during second‑trimester induced abortion, thereby assessing its therapeutic benefit in this clinical setting.

The trial enrolled female patients undergoing a second trimester induced abortion. The sponsor did not provide the total number of participants. Eligibility required written informed consent, age of 18 years or older, and a singleton viable gestation of 13 weeks or greater confirmed by ultrasound. Participants had to be willing to receive a paracervical block for pain relief and an intravenous patient controlled analgesia regimen during the procedure, and possess sufficient proficiency in the local language or English (or access to a certified interpreter). Selection was based on these inclusion criteria within a clinical setting; no additional lifestyle restrictions or specific health exclusions were reported. The population comprised adult women, classified as a vulnerable group, and were otherwise considered medically appropriate for the procedure.

The study is a randomized, double-blind, placebo-controlled trial evaluating a paracervical block with ropivacaine hydrochloride (262 mg, infiltration) versus an electrolyte placebo (mannitol 47 mg, infiltration) for pain relief during second‑trimester medical abortion. Recruitment is planned to begin on 2 September 2026 and conclude on 9 March 2028, with each participant followed from an initial screening visit through the procedural visit, subsequent follow‑up assessments, and a final end‑of‑study visit. The screening visit confirms eligibility criteria, obtains written informed consent, and records baseline data. During the procedural visit the assigned study product is administered and intravenous patient‑controlled analgesia is provided; the primary efficacy endpoint, the maximum pain score measured on a VAS (millimetres), is recorded throughout the procedure. Follow‑up visits are scheduled to monitor adverse events, assess pain resolution, and collect any additional outcome data, culminating in an end‑of‑study visit that finalizes data collection. Participant involvement typically spans the duration of the procedural and follow‑up visits, lasting several days to a few weeks. Early termination may occur if the participant withdraws consent, experiences a serious adverse event, fails to adhere to protocol requirements, or if the abortion procedure cannot be completed as planned.

The experimental arm utilizes ropivacaine hydrochloride supplied as the pharmaceutical form PHF00231MIG. Each dose consists of 262 mg administered by infiltration. The medication is given as a single injection immediately prior to the paracervical block during the second‑trimester medical abortion procedure.

The control arm receives a placebo preparation labeled ELECTROLYTES, containing mannitol as the active substance. The placebo is provided in the pharmaceutical form PHF00230MIG, with a dose of 47 mg delivered by infiltration. This injection is performed in an identical manner and timing to the active drug to maintain blinding.

Both study treatments are administered once per participant at the time of the paracervical block. Study personnel record the exact time of administration, verify the correct dose and route, and document any deviations. Compliance is monitored through direct observation of the injection and completion of case report forms. No additional concomitant medications are mandated by the protocol beyond standard‑of‑care management of the abortion procedure.

Efficacy will be assessed by the primary endpoint of maximum pain intensity recorded on a visual analog scale (VAS) measured in millimeters during the procedure. The VAS will be administered immediately after the procedure, and the highest score reported by each participant will be captured for analysis. Pain scores will be collected using a validated VAS instrument, and comparative statistical analyses will be performed between the ropivacaine infiltration group and the placebo group.