Paracervical Block for Pain Control During Osmotic Dilator Placement: a Randomized Controlled Trial

University of California, San Diego2 个研究点分布在 1 个国家目标入组 14 人开始时间: 2015年4月2日最近更新: 2019年6月11日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方: University of California, San Diego
入组人数: 14
试验地点: 2
主要终点: Pain at Time of Osmotic Dilator Placement

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Cervical dilators are frequently used for preparation prior to second trimester surgical abortion. While their use decreases complications associated with surgical abortion, their placement is often uncomfortable for the patient. Currently there are no proven methods for reducing pain during osmotic dilator placement. The use of numbing medication around the cervix (paracervical block) may decrease this placement pain.

详细描述

It is estimated that 1.21 million abortions were performed in 2008. Of these, approximately 11% occurred in the second trimester and 1.4% occurred after 21 weeks gestation. In the United States, dilation and evacuation (D&E) is the most common method of terminating a second trimester pregnancy with greater than 98% of second trimester abortions occurring by D&E.

Pre-procedure cervical preparation decreases the incidence of complications associated with D&E. Cervical dilators are often used prior to second trimester D&Es to aid in softening and dilating the cervix. Typically, dilator placement occurs the day of the D&E or 1-2 days prior and oftentimes occurs in an outpatient clinic setting without anesthesia readily available. Many women experience moderate to severe discomfort with osmotic dilator insertion. Providers use various methods to minimize this discomfort including paracervical block (PCB), non-steroidal anti-inflammatory medications (NSAIDs), anxiolytics and narcotics. In particular, PCB and NSAIDs are readily available in the clinic setting and can be used for this purpose. There is, however, no data to support their efficacy in ameliorating the pain of dilator insertion.

Paracervical blocks are used commonly to decrease pain in abortion procedures and other gynecological procedures. The PCB is thought to work primarily by blocking pain conduction via Frankenhauser's plexus. As such, their effect may be most important in relieving the pain associated with cervical dilation. In a recent randomized control trial, PCB prior to first trimester surgical abortion was found to significantly reduce pain with cervical dilation and uterine aspiration. Since osmotic dilator placement primarily involves cervical manipulation and dilation, PCB may provide some pain relief over placebo. The research team proposes a randomized controlled trial to evaluate the efficacy of a PCB in decreasing pain associated with osmotic dilator placement. This trial will also provide information about the degree of pain that women experience during osmotic dilator placement; information not previously known.

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)

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

•voluntarily seeking surgical pregnancy termination
•gestational age on day of study 14w0d to 23w6d confirmed by pelvic ultrasound with a viable pregnancy (no fetal demise diagnosed)
•eligible for second trimester D&E
•having osmotic dilators placed for cervical preparation the day prior to D&E
•able and willing to give informed consent and agree to terms of the study
•able to speak and read English or Spanish

排除标准

•took any prescription or illegal drugs 24 hours prior to the appointment
•drank alcohol 12 hours prior to the appointment
•took any over the counter pain medications 12 hours prior to the appointment other than the standard 800mg of Ibuprofen
•contraindications to osmotic dilators
•allergic reaction or hypersensitivity to NSAIDs or lidocaine
•untreated acute cervicitis or pelvic inflammatory disease
•weight <100 pounds

研究组 & 干预措施

Sham Group

Sham Comparator

This non-intervention group will receive the sham paracervical block. This intervention will include

Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement
Local anesthetic for tenaculum placement
Sham Paracervical Block done with capped spinal needle
osmotic dilators placed in the usual fashion
postprocedural assessment

干预措施: Local anesthetic for tenaculum placement (Procedure)

Sham Group

Sham Comparator

This non-intervention group will receive the sham paracervical block. This intervention will include

Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement
Local anesthetic for tenaculum placement
Sham Paracervical Block done with capped spinal needle
osmotic dilators placed in the usual fashion
postprocedural assessment

干预措施: Sham (Procedure)

Sham Group

Sham Comparator

This non-intervention group will receive the sham paracervical block. This intervention will include

Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement
Local anesthetic for tenaculum placement
Sham Paracervical Block done with capped spinal needle
osmotic dilators placed in the usual fashion
postprocedural assessment

干预措施: Dilator Placement (Procedure)

Sham Group

Sham Comparator

This non-intervention group will receive the sham paracervical block. This intervention will include

Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement
Local anesthetic for tenaculum placement
Sham Paracervical Block done with capped spinal needle
osmotic dilators placed in the usual fashion
postprocedural assessment

干预措施: Post-procedural assessment (Behavioral)

Sham Group

Sham Comparator

This non-intervention group will receive the sham paracervical block. This intervention will include

Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement
Local anesthetic for tenaculum placement
Sham Paracervical Block done with capped spinal needle
osmotic dilators placed in the usual fashion
postprocedural assessment

干预措施: Preprocedural pain control (Drug)