Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Pain scores during IUD placement procedure
研究概览
简要总结
The goal of this research study is to learn more about how different uses of a numbing medication might affect pain levels while getting an IUD placed. The investigators are also studying participants opinions of their clinicians' empathy.
The investigators are inviting patients who arrive at their clinic visit seeking an IUD.
Usually, at University of California, San Diego (UCSD), for patients who have never delivered a baby, clinicians use a buffered paracervical block for before IUD placement. The purpose of this research study is to investigate whether a "buffered" (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block (numbing medication given on both sides of the cervix) is effective in reducing pain during IUD placement in individuals with prior C-sections, the difference between buffered and unbuffered for nulliparous patients, and whether a medicated gel reduces pain with the paracervical block.
详细描述
Lidocaine is a drug that has been approved by the Food and Drug Administration (FDA). Sodium bicarbonate is an additive that buffers the acidity of lidocaine. The combination of the two is safe and effective as a paracervical block for pain relief in various OBGYN procedures. At UCSD and other places, it is not currently standard practice for people with prior deliveries birth to receive a paracervical block prior to IUD placement.
Participants who take part in this study, may receive an injection of buffered lidocaine (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine), an injection of unbuffered block, and/or lidocaine gel.
Throughout the local anesthetic and intrauterine device (IUD) placement procedure, research team members will present participants with questionnaires to complete to assess participants' pain, participants' satisfaction with the procedure, and how much empathy participants feel the clinician has shown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not know their group assignment. The clinicians will know which group the participant is in.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ability to provide informed consent
- •Women IUD placement for contraception or heavy menstrual bleeding
- •English-speaking
- •Participants must not have a past medical history of substance use disorders, pain disorders, use of prescription pain medications or are found to be pregnant
排除标准
- •No history of vaginal delivery
- •Current use of prescription pain medication prior to procedure. Over-the-counter medications such as those containing ibuprofen, aspirin, acetaminophen, or naproxen are allowed.
- •Diagnosed chronic pain condition
- •Current pregnancy
- •Known allergic reactions to components of the local anesthetic
- •History of an IUD placement
- •Current substance use or history of substance use
- •Known contraindications to IUD, such as unexplained vaginal bleeding
研究组 & 干预措施
1a: Buffered lidocaine paracervical block
Treatment group: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.
干预措施: Buffered Lidocaine (Drug)
1b: Capped needle
Sham group: will receive a capped needle without any medication administered as paracervical block before IUD placement. They will receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.
干预措施: Sham Comparator (Other)
2a: Buffered lidocaine paracervical block
Treatment group: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.
干预措施: Buffered Lidocaine (Drug)
2b: Unbuffered lidocaine paracervical block
Active comparator group: will receive a 20-mL unbuffered (1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.
干预措施: Unbuffered lidocaine (Drug)
3a: Medicated gel
Treatment group: will receive lidocaine-infused gel prior to administration of paracervical block.
干预措施: Xylocaine jelly 2% (Drug)
3b: Non-medicated gel
Placebo group: will receive a non-medicated gel prior to administration of paracervical block.
干预措施: Surgilube (Drug)
结局指标
主要结局
Pain scores during IUD placement procedure
时间窗: From speculum placement to 5 minutes post-procedure
Does buffered 1% lidocaine paracervical block decrease pain during IUD. placement procedures. Pain will be measured on a 10-cm Visual Analog Scale (VAS) with score points ranging from 0-10, where 0 means "No pain" and 10 means "Worst pain possible."
次要结局
- Patient perceptions of clinician empathy(From pre-procedure baseline to 5 minutes post-procedure)
研究者
Sheila Mody
Professor
University of California, San Diego