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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Global Pain Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: 1% Lidocaine Paracervical Block (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).
干预措施: Normal Saline Paracervical Injection (Drug)
结局指标
主要结局
Global Pain Score
时间窗: 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).
次要结局
- 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.)
研究者
Mara Sobel
Associate Professor
Mount Sinai Hospital, Canada