Clinical trial NCT06532162: The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment
Official title: The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment. a Double-blind, Triple Arm, Randomized Controlled Trial of 1% Lidocaine Paracervical Block for IUD Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Keywords: Contraception
Intrauterine device
Paracervical block
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 246
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Global Pain Score
timeFrame: Immediately following the procedure
Secondary outcomes:
measure: Pain at specific pain points
timeFrame: Baseline, after injection or placebo, tenaculum placement, uterine sounding, IUD insertion, 1 minute post-procedure
measure: Immediate complications following the procedure (i.e. vasovagal response, dizziness, local anesthetic toxicity syndrome)
timeFrame: Immediately following the procedure
measure: Length of time for analgesia
timeFrame: Immediately following administration of the intervention, placebo, or control
measure: Length of time for IUD placement
timeFrame: Immediately following the procedure
measure: Patient satisfaction
timeFrame: Immediately following the procedure
measure: Difficulty of IUD placement
timeFrame: 1 is minimum (least diffiult) and 5 is maximum (most difficult). Higher scores are worse outcome as they are more difficult.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References: