NCT06653400 Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
| NCT ID | NCT06653400 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Abnormal Uterine Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-27 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-02-27 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies.
Eligibility Criteria
Inclusion Criteria: * Patients assigned female at birth, * booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates. Exclusion Criteria: * Allergy to ketorolac or non-steroidal anti-inflammatory medications * Allergy to lidocaine * Presence of thrombocytopenia * Contraindications to lidocaine * History of gastritis or gastric ulcer * Acute renal failure or chronic renal disease * Chronic liver disease * History of bleeding diathesis * Long term narcotic use
Contact & Investigator
Charles Ascher-Walsh, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06653400 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Abnormal Uterine Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06653400 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06653400 currently recruiting?
Yes, NCT06653400 is actively recruiting participants. Contact the research team at kathleen.ackert@mssm.edu for enrollment information.
Where is the NCT06653400 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06653400 clinical trial?
NCT06653400 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Charles Ascher-Walsh, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 60 participants.