2.5% Lidocaine/2.5% Prilocaine Cream for IUD Insertion and Endometrial Biopsy
A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of Self-application of Lidocaine 2.5%/Prilocaine 2.5% Cream for Intrauterine Device (IUD) Insertion and Endometrial Biopsy
研究概览
地位
详细说明
The proposed study is a double-blind, placebo-controlled randomized controlled trial (RCT). 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.
Two separate randomization schedules will be generated, one for IUD insertion and one for endometrial biopsy, using computer-generated sequences prepared by an independent study coordinator. Randomization will occur via consecutively numbered, opaque, sealed envelopes containing the allocation code. Each participant will be randomly assigned to one of two arms: 1) Intervention (5g of 2.5% lidocaine/2.5% prilocaine cream in a pre-filled vaginal applicator). 2) Placebo (5g of VersaPro cream in a pre-filled vaginal applicator). The research coordinator (who is not involved in direct patient care) will open the allocation envelopes without the presence of the participant or the provider. They will prepare the self-applicators with either 5g of 2.5% lidocaine/2.5% prilocaine cream or 5g of placebo cream to maintain blinding. The patient will be instructed how to self-administer the applicator and dispense all 5g of cream into their vagina in the washroom. A patient education sheet highlighting instructions will also be provided. The patient will wait 10-15 mins and then will be brought into a room for the procedure. Once the procedure begins, pain scores at key intervals will be patient-reported by a 10-point numeric rating scale (NRS) and recorded by a research assistant. A global pain score using a 100mm visual analogue scale (VAS) at 5-minutes following the procedure will also be collected. Post-procedure, there will be a provider-completed questionnaire and a patient satisfaction questionnaire. The provider questionnaire will help describe details of the procedure and complications. The patient satisfaction questionnaire will describe feasibility, acceptability and satisfaction with self-administered cream. The primary outcome will be global pain score at 5-minutes post-procedure, which will be patient-reported by the 100 mm VAS. Secondary outcomes include: pain at specific pain points using a 10-point NRA (baseline after insertion of cream, after insertion of speculum, tenaculum placement, sounding of uterus (IUD only), IUD insertion or endometrial biopsy, and 1-minute post-procedure). Other secondary outcomes include pre- and post-procedure anxiety, procedural characteristics (uterine size, position, IUD type, number of biopsy passes), immediate complication and side effects, procedural difficulty, length of time to complete the procedure, and patient reported feasibility, acceptability, perceived control over pain and satisfaction.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mara Sobel, MD
- 电话号码：416-586-8273
- 邮箱：mara.sobel@sinaihealth.ca
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G1Z5
- Ontario Power Generation Building
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接触：
- Mara Sobel, MD
- 电话号码：416-586-8273
- 邮箱：mara.sobel@sinaihealth.ca
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首席研究员：
- Mara Sobel, MD
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副研究员：
- Praniya Elangainesan, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Any participant ≥18 years presenting for an IUD insertion or endometrial biopsy
- English speaking participants only
Exclusion Criteria:
- Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
- Misoprostol administration within 24 hours
- Confirmed pregnancy
- Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)
- Allergy to lidocaine, prilocaine or any other "-caine" type anesthetics or any of the non-medicinal ingredients found in the product
- Patients with congenital or idiopathic methemoglobinemia
- Patients with glucose-6-phosphate dehydrogenase deficiency
- Severe kidney or liver disease
- Previous history of local anesthetic systemic toxicity (LAST)
- Baseline vital signs of systolic blood pressure <100, diastolic blood pressure <60 and/or pulse <60.
- Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible)
- Active atopic dermatitis or skin involving vulva, vagina and/or cervix.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Medicated cream
5g of 2.5% lidocaine/2.5% prilocaine topical cream administered with vaginal self-applicator
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5g of 2.5% lidocaine/2.5% prilocaine topical cream administered by participant by vaginal self-applicator
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安慰剂比较：Placebo cream
5g of placebo VersaPro topical cream administered with vaginal self-applicator
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5g of VersaPro cream administered by participant by vaginal self-applicator
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Global pain score
大体时间：Completed by patient 5-minutes post procedure.
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Patient-reported pain measured using the 100-mm Visual Analogue Scale (VAS) 5 minutes following the procedure (endometrial biopsy or IUD insertion).
The VAS ranges from 0 mm (no pain) to 100 mm (worst pain imaginable), with higher scores indicating greater pain (a worse outcome).
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Completed by patient 5-minutes post procedure.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain scores at specific pain points during procedure
大体时间：During the procedure
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Pain scores at specific pain points: baseline after insertion of cream, after insertion of the speculum, removal of excess cream with gauze, placement of tenaculum, sounding (IUD only), IUD insertion/endometrial biopsy, and 1-minute post-procedure, which will be patient-reported verbally during the procedure on a scale from 0 (i.e.
no pain) to 10 (worst pain imaginable).
When more than one biopsy pass is required, only pain after the first pass will be recorded.
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During the procedure
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Anxiety levels
大体时间：After application of the cream and waiting for 10 minutes but before starting the procedure as well as at 1-minute after the procedure.
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Patient-reported anxiety before and after the procedure, measured using a 5-point Likert scale ranging from 1 (very anxious) to 5 (very calm).
Higher scores indicate less anxiety (a better outcome).
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After application of the cream and waiting for 10 minutes but before starting the procedure as well as at 1-minute after the procedure.
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Immediate complications of endometrial biopsy and/or IUD insertion
大体时间：Completed by the provider immediately after the procedure (within 30 mins post procedure).
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Provider-reported immediate complications associated with the endometrial biopsy and/or IUD insertion, including difficulty of procedure, vasovagal reaction, vital sign changes, or other procedure-related complications.
This will be assessed by the presence or absence of specific procedure-related complications.
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Completed by the provider immediately after the procedure (within 30 mins post procedure).
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Difficulty of procedure
大体时间：Completed by the provider immediately after the procedure (within 30 mins post procedure).
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The difficulty of the procedure will be assessed with a Likert scale from 1 (least difficult) to 5 (most difficulty), provider reported.
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Completed by the provider immediately after the procedure (within 30 mins post procedure).
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Length of time for procedure completion
大体时间：During the procedure
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Time will be recorded via stopwatch
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During the procedure
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Patient-reported acceptability, feasibility, and satisfaction with vaginal cream self-administration
大体时间：Completed by the patient immediately after the procedure (within 30 mins post procedure).
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Patient-reported acceptability and satisfaction with self-administration will be assessed using a study-specific questionnaire evaluating ease and comfort of self-administration, perceived control, satisfaction with pain control and the self-application process, and willingness to use self-administration for a future gynecologic procedure. Ease of administration, comfort with self-administration, satisfaction with pain control, satisfaction with the self-application process, and likelihood of choosing self-administration again will each be assessed using 5-point Likert scales ranging from 1 to 5, with higher scores indicating greater ease, comfort, satisfaction, or likelihood of future use (a better outcome). Additional acceptability measures, including confidence in correct application, difficulty with application, perceived control, and willingness to choose the same pain-control method in the future, will be reported descriptively based on categorical responses (Yes/No/Unsure) |
Completed by the patient immediately after the procedure (within 30 mins post procedure).
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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