drugset / Trial / NCT06532162

The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment

NCT06532162

Phase 2 Completed 246 enrolled Mount Sinai Hospital, Canada
RandomizedParallel-groupTriple-blindPrevention

Summary

Intrauterine devices (IUDs) are a highly effective form of reversible contraception with a less than 1% failure rate. They can be easily placed in the office and require little maintenance care. However, despite their benefits, pain during insertion remains a barrier for patient uptake. Currently there is no standard of care for pain management during IUD insertion. The aim of this study is to determine whether local anesthetic, in the form of injecting 1 percent lidocaine into the cervicovaginal junction, reduces pain during insertion. Participants will be randomly assigned to receive 1 percent lidocaine, placebo, or no injection. All patients presenting for IUD placement, regardless of indication, will be offered participation in the study. Following IUD placement, patients will be asked to rate their pain at key "pain points" during the procedure as the primary outcome. Other outcomes collected will include provider-related complications, length of time to place IUD, and overall patient and provider satisfaction.

Timeline

Start
2022-06-30
Primary completion
2024-08-16
Completion
2024-08-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 10 ml Other
Background Epinephrine Other / unclassified Other

Indications

No indication recorded.