12 Versus 20 mL Paracervical Block for Pain-Control During Cervical Preparation for Dilation and Evacuation: A Single-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Pain Immediately Following Dilator Insertion
研究概览
简要总结
More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.
详细描述
This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.
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
The provider and staff will be aware of arm allocation, but participants will remain blinded.
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
- •Women 18 and older
- •Intrauterine pregnancy ≥16 weeks gestation
- •English speaking competency
- •Willing and able to sign consent forms
- •Agree to comply with study procedures
排除标准
- •Women less than 18 years of age
- •IV conscious sedation
- •Known allergy to study medication (lidocaine)
- •Any women not meeting inclusion criteria above will be excluded from participation
研究组 & 干预措施
12 mL arm
Intervention:
- Syringe loaded with 12 mL of 1% lidocaine (120 mg); 22-gauge spinal needle
- 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix
- The tenaculum is immediately placed at the previously injected site
- The remaining 10 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal)
- No wait time between injection and dilator insertion
干预措施: 12 mL paracervical block (Drug)
20 mL arm
Intervention:
- Syringe loaded with 20 mL of 1% lidocaine (120 mg); 22-gauge spinal needle
- 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix
- The tenaculum is immediately placed at the previously injected site
- The remaining 18 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal)
- No wait time between injection and dilator insertion
干预措施: 20 mL paracervical block (Drug)
结局指标
主要结局
Pain Immediately Following Dilator Insertion
时间窗: Time of dilator insertion (less than 1 minute to assess pain)
The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable).
次要结局
- Anticipated Pain Immediately Prior to Dilator Insertion(Up to 1 minute to complete survey)
- Patient Global Satisfaction Score(Up to 1 minute to complete survey)
- Total Procedure Time(Up to 10 minutes)
- Physician-reported Ease of Insertion(Up to 1 minute to complete survey)
- Count of Participants With Side Effects Related to Lidocaine Administration(Up to 10 minutes)
- Count of Participants With Procedural Complications(Up to 10 minutes)