The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment

The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment. a Double-blind, Triple Arm, Randomized Controlled Trial of 1% Lidocaine Paracervical Block for IUD Insertion

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.

Inclusion Criteria:

• Any participant presenting for an IUD placement, either for contraception or treatment of abnormal uterine bleeding or to regulate menstrual periods
• All IUDs (copper, hormonal) eligible
• All parities of patients are eligible

Exclusion Criteria:

• Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
• Confirmed pregnancy
• Any diagnosed chronic pain conditions (fibromyalgia, vaginismus, interstitial cystitis)
• Misoprostol administration within 24 hours of enrollment
• Known contraindications to IUD placement
• Contraindication to lidocaine
• IUD exchange
• Previous unsuccessful attempt for IUD by the same practitioner