A Double-blind Randomized Controlled Trial of 1% Lidocaine Paracervical Block for Endometrial Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Global pain score
研究概览
简要总结
The objective of this study is to to determine whether 1% lidocaine paracervical block reduces pain during endometrial biopsy in comparison to no intervention.
The proposed study is a double-blind randomized controlled trial (RCT).
Each participant will be randomly assigned to one of two arms:
- intervention (paracervical block - 10 mL 1% lidocaine with epinephrine)
- control (gently tapping the cervicovaginal junction with a capped needle)
The primary outcome will be a global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) following the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The investigators will employ a two provider system 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. Provider A will place the speculum, and administer either the intervention 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 tenaculum and perform the endometrial biopsy 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 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
- 是
入选标准
- •Any participant > or = age 18 years old presenting for an endometrial biopsy
- •All parities of patients are eligible
- •English speaking participants only
排除标准
- •Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzos) within past 24 hours
- •Confirmed pregnancy
- •Any diagnosed chronic pain syndromes (eg. fibromyalgia, vaginismus, interstitial cystitis)
- •Contraindication to lidocaine
- •Misoprostol administration within 24 hours
- •Previous unsuccessful office attempt at endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful biopsy attempt by a different practitioner will still be eligible)
研究组 & 干预措施
1% lidocaine paracervical injection
10 cc 1% lidocaine with epinephrine paracervical injection
干预措施: Lidocaine 1% Injectable Solution (Drug)
control
gently tapping the cervicovaginal junction with a capped needle
干预措施: Capped needle (Other)
结局指标
主要结局
Global pain score
时间窗: Immediately after the completion of the procedure
100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable)
次要结局
- Immediate complications of endometrial biopsy and/or intervention/control(Immediately after the completion of the procedure)
- Difficulty for provider to complete the biopsy(Immediately after the completion of the procedure)
- Patient satisfaction(Immediately after the completion of the procedure)
- Length of time for endometrial biopsy completion(During procedure)
- Length of time for analgesia(During procedure)
- Number of passes with biopsy pipelle to collect sufficient tissue(Immediately after the completion of the procedure)
- Amount of tissue obtained: scant, minimal, adequate(Immediately after the completion of the procedure)
- Pain scores during procedure(During the procedure)
研究者
Mara Sobel
Prinicipal Investigator (Dr.)
Mount Sinai Hospital, Canada