The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment

NCT06532162 | Completed Phase 2

• 1 other identifier: PRICE Trial
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

Contraception; Intrauterine device; Paracervical block

Outcome Measures

Primary Outcomes (1)

• Global Pain Score

  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).

  Immediately following the procedure

Secondary Outcomes (6)

• Pain at specific pain points

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

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

  Immediately following the procedure

• Length of time for analgesia

  Immediately following administration of the intervention, placebo, or control

• Length of time for IUD placement

  Immediately following the procedure

• Patient satisfaction

  Immediately following the procedure

Study Arms (3)

1% Lidocaine Paracervical Block

EXPERIMENTAL

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).

Drug: 1% Lidocaine Paracervical Block

Normal Saline Paracervical Injection

SHAM COMPARATOR

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).

Drug: Normal Saline Paracervical Injection

Capped Needle Control

NO INTERVENTION

A capped needle will gently be tapped on the cervicovaginal junction at two areas at 2 and 10 o'clock.

Interventions

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).

1% Lidocaine Paracervical Block

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).

Normal Saline Paracervical Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1Z5, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We will employ two providers to ensure a double-blinded set-up. The first provider (Provider A) will open the allocation envelopes without the presence of the participant or second provider (Provider B). Provider A will then enter the patient's room and introduce themselves. They will place the speculum, and administer either the intervention, placebo, or control and then leave the room after injection-related bleeding has stopped. After 3 minutes, the second provider (Provider B) will enter the room to place the IUD (including sounding and tenaculum placement) and will be unaware of the participant's treatment arm. A standardized script will be used with all participants: "You may or not may feel a poke." Both lidocaine and the control (normal saline) are odorless and clear, minimizing the risk of unblinding. All data will remain blinded until data analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The proposed study is a double-blind, triple arm, placebo-controlled randomized clinical trial. Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure, and post-procedure survey will occur during the same visit. Each participant will be randomly assigned to one of three arms: 1. Intervention (10 cc 1% lidocaine paracervical block) 2. Placebo (10 cc paracervical injection of normal saline) 3. Control (gently tapping the cervicovaginal junction with a capped needle)

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: June 30, 2022
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)