Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement

Phase 2Not Yet RecruitingNCT07487246

Rush University Medical Center76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain Management Abortion Second Trimester Abortion Dilation and Evacuation

Interventions

KetorolacDRUG

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.

oral ibuprofenDRUG

Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.

PlaceboDRUG

Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.

Lidocaine HCl 1%DRUG

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.

SalineDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age of at least 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 singleton intrauterine pregnancy with an estimated gestational age of 16+0-24+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 Criteria: * 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 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)

Outcomes

Primary Outcomes

Pain post-osmotic 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)

Time frame: 5 minutes and 30 minutes post-dilator insertion

Secondary Outcomes

Pain with maintenance of osmotic dilators

i. Median change in NRS from baseline (Time A) to Times F, G, H, I, J ii. Total quantity oxycodone used between end of clinic visit and presentation to preop the next day

Time frame: Over 24 hours post-insertion

Patient Satisfaction

iii. Overall patient satisfaction with pain control (measured with NRS)

Time frame: 24 hours post-dilator insertion

Provider interpretation of pain

iv. Physician-rated ease of dilator insertion (No difficulty, somewhat, very) + physician interpretation of patient's comfort during insertion (measured with NRS)

Time frame: Immediately after dilator insertion