Pain ManagementPhase 2PCB-KinDNCT07487246
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
A Phase 2 study testing Ketorolac, oral ibuprofen and Lidocaine HCl 1% in people with Pain Management and Abortion, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain Management, Abortion, Second Trimester Abortion
- What is being tested?
- Ketorolac, oral ibuprofen and Lidocaine HCl 1%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2026to 30 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Effects of Paracervical Block With Combined Ketorolac and Lidocaine on Perceived Pain in Osmotic Dilator Placement for Abortion, a Randomized Controlled Trial
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.
Read the detailed 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 (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.
- Being tested
- Ketorolac, oral ibuprofen, Placebo, Lidocaine HCl 1%, Saline
- Keywords
- randomized controlled trial, osmotic dilators, ketorolac, paracervical block
- Medical subject headings
- Agnosia, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Treatment Group | Experimental | Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac Receives: Drug: Ketorolac; Drug: Placebo; Drug: Lidocaine HCl 1% |
| Standard Treatment | Active comparator | Oral ibuprofen with plain 1% lidocaine paracervical block Receives: Drug: oral ibuprofen; Drug: Lidocaine HCl 1%; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain post-osmotic dilator insertion
- Mean difference between arms in NRS immediately after insertion of osmotic dilators
Measured: After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal
Secondary outcomes (3)
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.
Measured: 5 minutes to 6 hours after insertion of osmotic dilators
Patient Satisfaction
Mean difference in satisfaction measured with 100mm VAS.
Measured: 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)
Measured: Intraoperatively at start of D&E
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start29 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sadia MA Haider, MD, MPH, Principal investigator, Rush University Medical CenterKathryn Crofton, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487246
- Sponsor's protocol ID
- 25111201-IRB01
- Acronym
- PCB-KinD
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Paracervical Block With Combined Ketorolac and Lidocaine on Perceived Pain in Osmotic Dilator Placement for Abortion, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07487246
- Acronym / sponsor ID
- PCB-KinD / 25111201-IRB01
- Keywords
- randomized controlled trial, osmotic dilators, ketorolac, paracervical block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 (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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Treatment Group | Experimental | Drug: Ketorolac, Drug: Placebo, Drug: Lidocaine HCl 1%Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac |
| Standard Treatment | Active comparator | Drug: oral ibuprofen, Drug: Lidocaine HCl 1%, Drug: SalineOral ibuprofen with plain 1% lidocaine paracervical block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacSubjects 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. | Drug | Intervention Treatment Group |
| oral ibuprofenSubjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement. | Drug | Standard Treatment |
| PlaceboSubjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement. | Drug | Intervention Treatment Group |
| 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. | Drug | Intervention Treatment Group, Standard Treatment |
| SalineImmediately 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. | Drug | Standard Treatment |
Primary outcome
Pain post-osmotic dilator insertion
Time frame: After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal
i. Mean difference between arms in NRS immediately after insertion of osmotic dilators
3 secondary outcomes
Pain with maintenance of osmotic dilators
Time frame: 5 minutes to 6 hours after insertion of osmotic dilators
Patient Satisfaction
Time frame: 5 minutes after insertion of osmotic dilators
Cervical dilators (exploratory)
Time frame: Intraoperatively at start of D&E
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sadia MA Haider, MD, MPH principal investigator
Rush University Medical Center
Kathryn Crofton, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketorolac, oral ibuprofen and Lidocaine HCl 1% in people with Pain Management and Abortion, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina MA Barkowski, MSW, DrPH(s) (312-942-6382, cristina_m_barkowski@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain post-osmotic dilator insertion (time frame: After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.