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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Treatment Group | Experimental | Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac |
|
| Standard Treatment | Active Comparator | Oral ibuprofen with plain 1% lidocaine paracervical block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain post-osmotic dilator insertion | i. Mean difference between arms in NRS immediately after insertion of osmotic dilators | After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal |
| Measure | Description | Time Frame |
|---|---|---|
| Pain with maintenance of osmotic dilators | Mean difference between arms in NRS at 5 minutes (in clinic), 30 minutes and 1, 2, 4, 6 hours (all by text-message) after insertion of osmotic dilators. | 5 minutes to 6 hours after insertion of osmotic dilators |
| Patient Satisfaction |
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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 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 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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina MA Barkowski, MSW, DrPH(s) | Contact | 312-942-6382 | cristina_m_barkowski@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sadia MA Haider, MD, MPH | Rush University Medical Center | Principal Investigator |
| Kathryn Crofton, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D007052 | Ibuprofen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| oral ibuprofen | Drug | Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement. |
|
| Placebo | Drug | 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. |
|
| Saline | 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. |
|
Mean difference in satisfaction measured with 100mm VAS. |
| 5 minutes after insertion of osmotic dilators |
| Cervical dilators (exploratory) | Cervical dilation assessed with digital exam after removal of osmotic dilators at time of D&E; mechanical dilation performed during D&E (yes/no) | Intraoperatively at start of D&E |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |