Effects of Paracervical Block With Combined Ketorolac and Lidocaine on Perceived Pain in Osmotic Dilator Placement for Abortion, a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Pain post-osmotic dilator insertion
研究概览
简要总结
The purpose of this study is to improve pain management for participantswho need osmotic dilators for cervical preparation the day before their second trimester abortion procedure.
详细描述
The purpose of this study is to improve pain management for participantswho need osmotic dilators for cervical preparation the day before their second trimester abortion procedure. Osmotic dilators are sticks that are inserted into the cervix. They soak up fluid and expand overnight, gently opening the cervix. We are studying an injection of ketorolac (a liquid anti-inflammatory medication similar to ibuprofen) combined with lidocaine (a liquid numbing medication), which is injected vaginally to the area surrounding the cervix. Ketorolac is approved by the U.S. Food and Drug Administration (FDA) for intravenous (IV) and intramuscular injection and has been studied as a paracervical injection for participants having first trimester abortion procedures in the office. It has not previously been studied for osmotic dilator insertion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years English or Spanish speaking Ability and willingness to sign the informed consent Ability and willingness to comply with the terms of the study including possessing active cell phone with text messaging capabilities Voluntary request for pregnancy termination Ultrasound-confirmed intrauterine pregnancy with an estimated gestational age of 16+0-23+6 weeks gestational age Require osmotic dilator placement one day prior to procedural abortion according to institutional protocol Seeking outpatient abortion services at Rush University Medical Center
排除标准
- •Have taken NSAIDs less than 6 hours prior to their clinic visit Contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria Allergic reaction or sensitivity to NSAIDs History of peptic ulcer or gastrointestinal bleed, history of gastric bypass (RYGB) or recent history in last 6 months of gastric sleeve; history of inflammatory bowel disease (Ulcerative colitis, Crohn's disease) Uncontrolled hypertension, heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease Acute renal failure or chronic renal disease Chronic liver disease History of bleeding diathesis Untreated acute cervicitis or pelvic inflammatory disease Require or request PO benzodiazepine or IV sedation for placement of osmotic dilators Require more than 1 day of osmotic dilators Chronic or current narcotic use Current recreational drug use (excluding cannabis) Require transabdominal/transvaginal injection for induced fetal demise prior to abortion
研究组 & 干预措施
Intervention Treatment Group
Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac
干预措施: Placebo (Drug)
Standard Treatment
Oral ibuprofen with plain 1% lidocaine paracervical block
干预措施: Saline (Drug)
Standard Treatment
Oral ibuprofen with plain 1% lidocaine paracervical block
干预措施: oral ibuprofen (Drug)
Standard Treatment
Oral ibuprofen with plain 1% lidocaine paracervical block
干预措施: Lidocaine HCl 1% (Drug)
Intervention Treatment Group
Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac
干预措施: Ketorolac (Drug)
Intervention Treatment Group
Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac
干预措施: Lidocaine HCl 1% (Drug)
结局指标
主要结局
Pain post-osmotic dilator insertion
时间窗: 5 minutes and 30 minutes post-dilator insertion
i. Median change in NRS from baseline (Time A) to 5 minutes post osmotic dilator insertion (Time D) ii. Median change in NRS from baseline (Time A) to 30 minutes post osmotic dilator insertion (Time E)
次要结局
- Pain with maintenance of osmotic dilators(Over 24 hours post-insertion)
- Patient Satisfaction(24 hours post-dilator insertion)
- Provider interpretation of pain(Immediately after dilator insertion)