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Local Anesthetic

Lidocaine Injection for Pain During IUD Insertion (PRICE Trial)

Phase 2
Recruiting
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within the past 24 hours
Known contraindications to IUD placement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following the procedure
Awards & highlights

Summary

This trial aims to see if injecting a local anesthetic (1 percent lidocaine) near the cervix can reduce pain during the insertion of intrauterine devices (IUDs). Patients will

Who is the study for?
The PRICE Trial is for individuals seeking to have an intrauterine device (IUD) inserted for birth control. Participants must be willing to rate their pain during the procedure. There are no specific inclusion or exclusion criteria provided, suggesting that anyone presenting for IUD placement may be offered participation.
What is being tested?
This trial tests if a local anesthetic (1% lidocaine injection at the cervicovaginal junction) reduces pain during IUD insertion compared to a placebo saline injection or no injection at all. Patients will be randomly assigned to one of these three groups and asked about their pain experience afterward.
What are the potential side effects?
Potential side effects could include discomfort from the injections themselves, possible allergic reactions to lidocaine, and typical side effects associated with IUD insertion like cramping or bleeding.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken opioids or similar pain meds in the last 24 hours.
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I cannot have an IUD due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after injection or placebo, tenaculum placement, uterine sounding, iud insertion, 1 minute post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after injection or placebo, tenaculum placement, uterine sounding, iud insertion, 1 minute post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Global Pain Score
Secondary outcome measures
Difficulty of IUD placement
Immediate complications following the procedure (i.e. vasovagal response, dizziness, local anesthetic toxicity syndrome)
Length of time for IUD placement
+3 more

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692
40%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 1% Lidocaine Paracervical BlockExperimental Treatment1 Intervention
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 4 and 10 o'clock. The injection is continuous from superficial to deep (3 cm).
Group II: Capped Needle ControlActive Control1 Intervention
A capped needle will gently be tapped on the cervicovaginal junction at two areas at 4 and 10 o'clock.
Group III: Normal Saline Paracervical InjectionPlacebo Group1 Intervention
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 4 and 10 o'clock. The injection is continuous from superficial to deep (3 cm).

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Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
200 Previous Clinical Trials
68,910 Total Patients Enrolled
~78 spots leftby Sep 2025
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