Skip to main content
OpenTrials
Completed

NCT Number: NCT06532162

The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1Z5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1% Lidocaine Paracervical Block

Drug

A 22-gauge spinal needle will be loaded with 10 mL of 1% lidocaine with epinephrine.

The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm).

Normal Saline Paracervical Injection

Drug

A 22-gauge spinal needle will be loaded with 10 mL of normal saline. The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm).

Primary outcomes

  1. Global Pain Score

    Time frame: Immediately following the procedure

    Patient-reported overall pain score on the 100 mm Visual Analogus Scale (VAS). A score of 0 mm is the minimum, 100 mm is the maximum, with higher scores indicating more pain (i.e. worse outcome).

Secondary outcomes

  1. Pain at specific pain points

    Time frame: Baseline, after injection or placebo, tenaculum placement, uterine sounding, IUD insertion, 1 minute post-procedure

    Patient-reported pain score at specific pain points during the procedure, on the 100 mm Visual Analogus Scale (VAS). A score of 0 mm is the minimum, 100 mm is the maximum, with higher scores indicating more pain (i.e. worse outcome).

  2. Immediate complications following the procedure (i.e. vasovagal response, dizziness, local anesthetic toxicity syndrome)

    Time frame: Immediately following the procedure

    Provider reported based on events during the procedure

  3. Length of time for analgesia

    Time frame: Immediately following administration of the intervention, placebo, or control

    Stopwatch

  4. Length of time for IUD placement

    Time frame: Immediately following the procedure

    Stopwatch

  5. Patient satisfaction

    Time frame: Immediately following the procedure

    Survey-related questions, based on Likert scale and yes/no answers

  6. Difficulty of IUD placement

    Time frame: 1 is minimum (least diffiult) and 5 is maximum (most difficult). Higher scores are worse outcome as they are more difficult.

    Provider reported on Likert scale

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Official study title

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

Acronym: PRICE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2024
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.