Self-administrated vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous caesarean delivery only: a randomised, double-blind placebo-controlled trial.

What Was Tested

The paper reports a study of Copper (Supplement), published as a randomized controlled trial.

Who Took Part

By PubMed's age tags, the people studied were adults, women only.

A Randomised, double-blind, placebo-controlled trial (Clinicaltrials.gov: NCT03166111) included reproductive-aged women who previously delivered only by caesarean section (CS) requesting Copper IUD insertion.

Eligible women were recruited and randomised (1:1) to lidocaine in-situ gel vs. placebo.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Random assignment meant chance, not the researchers, decided who got Copper (Supplement) and who got the comparison, which limits bias.

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

Some participants received a placebo instead of Copper (Supplement), giving a reference point.

Each woman was supplied by a syringe filled with five ml lidocaine or placebo in-situ gel to be self-administered vaginally ten minutes before insertion.

The primary outcome was the difference in pain scores during IUD placement using a 10-cm Visual Analogue Scale (VAS).

What Was Measured

The subject headings attached to it are Anesthetics, Local, Cesarean Section, Gels, Intrauterine Devices, Copper, Lidocaine, Pain and Pain Management.

The authors tagged it with the keywords in situ gel and pain relief.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Copper (Supplement).

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2021 (The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception), a journal based in England.

More context: the Copper (Supplement) compound page, all human trials.