Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT06653400
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Abnormal Uterine Bleeding
- Analgesia
- Paracervical Block
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- paracervical block — PROCEDUREparacervical block with office hysteroscopy
- Lidocaine — DRUGDosage: 20 mL of 1% lidocaine
- ketorolac — DRUGDosage: 2 mL (30 mg) of ketorolac
Study Details
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.
Key Dates
- Start date
- Feb 27, 2025
- Status verified
- Sep 2025
- Primary completion
- Sep 1, 2026
- Completion
- Sep 1, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Lidocaine aloneParacervical block will be performed with just lidocaine
- Experimental: Lidocaine plus ketorolacParacervical block will be performed with lidocaine plus ketorolac
Primary Outcome Measure
Pain visual analogue scale (VAS) [ Time Frame: during procedure (cervical dilation) ]
Central Contacts
- Kathleen E Ackert, DO212-241-4500
- Virginia H Flatow, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mount Sinai | New York | New York | 10029 | Charles Ascher-Walsh, MD Virginia Flatow, MD Kathleen E Ackert (SUB_INVESTIGATOR) |
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