The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment

Phase 2

Completed

• Conditions: Contraception
• Interventions: Drug: 1% Lidocaine Paracervical Block; Drug: Normal Saline Paracervical Injection

• Registration Number: NCT06532162
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-30
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-01
• Primary Completion: 2024-08-16
• Study Completion: 2024-08-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% Lidocaine Paracervical Block	1% Lidocaine Paracervical Block	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	Normal Saline Paracervical Injection	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 Outcome Measures

Name	Time	Method
Global Pain Score	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 Outcome Measures

Name	Time	Method
Pain at specific pain points	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).
Immediate complications following the procedure (i.e. vasovagal response, dizziness, local anesthetic toxicity syndrome)	Immediately following the procedure	Provider reported based on events during the procedure
Length of time for analgesia	Immediately following administration of the intervention, placebo, or control	Stopwatch
Length of time for IUD placement	Immediately following the procedure	Stopwatch
Patient satisfaction	Immediately following the procedure	Survey-related questions, based on Likert scale and yes/no answers
Difficulty of IUD placement	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

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada