Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o

What Was Tested

In this phase 3 trial, researchers set out to test Vasopressin.

The investigators are studying how different ratios of medication to liquid affect pain when injected around the cervix.

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Most procedures are performed while the patient is awake or with minimal sedation in the clinic setting, and a key component of pain control is the paracervical block, or injecting lidocaine into the tissue around the cervix.

Therefore, the D\&C is a required procedure for both study groups.

The only difference in care between the study groups will be which paracervical block they receive.

Who Took Part

The registry lists 114 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Undesired pregnancy or missed abortion \< 11 weeks 6 days gestation. Must speak English or Spanish. Desire surgical termination of pregnancy or management of miscarriage in clinic.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: women with a diagnosis of inevitable or incomplete abortion; desire for general anesthesia or iv sedation; chronic pain conditions.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2018-10-29 with completion listed for 2020-12-14.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pain With Cervical Dilation.

It also tracked 3 secondary outcomes, for example Pain With Uterine Aspiration, Pain 10 Minutes Post Procedure and Overall Pain.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Vasopressin in 114 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Vasopressin compound page, all human trials.