Effects of Paracervical Block With Combined Ketorolac and Lidocaine on Perceived Pain in Osmotic Dilator Placement for Abortion, a Randomized Controlled Trial
Rush University Medical Center
Summary
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.
Description
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 (FD…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion criteria: 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 Exclusion…
Interventions
- DrugKetorolac
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.
- Drugoral ibuprofen
Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.
- DrugPlacebo
Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.
- DrugLidocaine 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.
- DrugSaline
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.
Location
- Rush University Medical CenterChicago, Illinois