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
Overview
- Phase
- Phase 2
- Intervention
- 1% Lidocaine Paracervical Block
- Conditions
- Contraception
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Global Pain Score
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Mara Sobel
Associate Professor
Mount Sinai Hospital, Canada
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
Arms & Interventions
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: 1% Lidocaine Paracervical Block
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: Normal Saline Paracervical Injection
Outcomes
Primary Outcomes
Global Pain Score
Time Frame: Immediately following the procedure
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).
Secondary Outcomes
- 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)
- Difficulty of IUD placement(1 is minimum (least diffiult) and 5 is maximum (most difficult). Higher scores are worse outcome as they are more difficult.)