Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement

Официальное название

Effects of Paracervical Block With Combined Ketorolac and Lidocaine on Perceived Pain in Osmotic Dilator Placement for Abortion, a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ketorolac
  Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement. Immediately prior to placement of osmotic dilators, a 1% lidocaine + ketorolac paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL ketorolac (30mg) will be administered.
• Препарат oral ibuprofen
  Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.
• Препарат Placebo
  Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.
• Препарат Lidocaine HCl 1%
  Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed in the following fashion: Two milliliters of the analgesic mixture will be placed at the tenaculum site intracervically. After the tenaculum is placed, the remaining 18 mL of the analgesic mixture will be administered at 4 and 8 o'clock at the cervicovaginal reflection.
• Препарат Saline
  Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed.

Первичные конечные точки

• Pain post-osmotic dilator insertion [Срок оценки: After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal]

Вторичные конечные точки (3)

• Pain with maintenance of osmotic dilators [Срок оценки: 5 minutes to 6 hours after insertion of osmotic dilators]
• Patient Satisfaction [Срок оценки: 5 minutes after insertion of osmotic dilators]
• Cervical dilators (exploratory) [Срок оценки: Intraoperatively at start of D&E]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Rush University Medical Center — Chicago

Идентификаторы

NCT: NCT07487246 · 25111201-IRB01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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