The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment

Mount Sinai Hospital, Canada

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: 1% Lidocaine Paracervical Block; Drug: Normal Saline Paracervical Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06532162

PRICE Trial

Details and patient eligibility

About

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.

Enrollment: 246 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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246 participants in 3 patient groups

1% Lidocaine Paracervical Block

Experimental group

Description:

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).

Treatment:

Drug: 1% Lidocaine Paracervical Block

Normal Saline Paracervical Injection

Sham Comparator group

Description:

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).

Treatment:

Drug: Normal Saline Paracervical Injection

Capped Needle Control

No Intervention group

Description:

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