The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2024-08-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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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).

Group Type EXPERIMENTAL

1% Lidocaine Paracervical Block

Intervention Type 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

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).

Group Type SHAM_COMPARATOR

Normal Saline Paracervical Injection

Intervention Type 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).

Capped Needle Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No