Abnormal Uterine BleedingPhase 1NCT06653400
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
A Phase 1 study testing paracervical block, Lidocaine and ketorolac in people with Abnormal Uterine Bleeding and Analgesia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Uterine Bleeding, Analgesia, Paracervical Block
- What is being tested?
- paracervical block, Lidocaine and ketorolac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Phase 1
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients assigned female at birth,
- booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates.
Who cannot join
- 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
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- Chronic liver disease
- History of bleeding diathesis
- Long term narcotic use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy: a Randomized Controlled Trial
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.
Read the detailed description
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. Primary Objective: To study the effect of a combined ketorolac and lidocaine paracervical block on procedure related pain with office hysteroscopy. Secondary Objectives: To study the effect of a combined ketorolac and lidocaine paracervical block on patient satisfaction and post procedure pain. To assess for major adverse events with the use of a combined ketorolac and lidocaine paracervical block for office hysteroscopy when compared with a standard lidocaine paracervical block. Primary Endpoint: Pain on a 100 mm visual analogue scale during cervical dilation. Secondary Endpoints: Pain on a 100 mm visual analogue scale during the paracervical block, during the office hysteroscopy, immediately after the hysteroscopy, and 30 minutes after the procedure. Other secondary endpoints include patient satisfaction, frequency of procedure termination, and adverse events. Patients assigned female at birth, booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates. Patients scheduled for office hysteroscopy through seeing a Gynecologist at either 5 E 98th Street Faculty Practice Associates or 1176 5th Avenue Gynecology Practice. 5 E 98th Street primarily cares for privately insured patients, while 1176 5th Avenue cares for a mix of privately insured as well as patients insured with Medicaid. Regardless of recruitment site, all office hysteroscopies will be performed at the 5 E 98th Street facility. A randomized controlled trial designed to investigate if ketorolac added to a paracervical block reduces procedure related pain. Patient will be randomized to a standard paracervical block versus a paracervical block with ketorolac added. The study will be conducted over two years. Patients will be followed for the duration of the two-year study period.
- Conditions
- Abnormal Uterine Bleeding, Analgesia, Paracervical Block
- Being tested
- paracervical block, Lidocaine, ketorolac
- Medical subject headings
- Metrorrhagia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracervical blockProcedure or surgery
paracervical block with office hysteroscopy
LidocaineDrug
Dosage: 20 mL of 1% lidocaine
ketorolacDrug
Dosage: 2 mL (30 mg) of ketorolac
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine alone | Placebo comparator | Paracervical block will be performed with just lidocaine Receives: Procedure: paracervical block; Drug: Lidocaine |
| Lidocaine plus ketorolac | Experimental | Paracervical block will be performed with lidocaine plus ketorolac Receives: Procedure: paracervical block; Drug: Lidocaine; Drug: ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain visual analogue scale (VAS)
Pain as measured on a 100 mm visual analogue scale (VAS) with cervical dilation.
Full scale scored from 0-100, higher score indicates more pain.
Measured: during procedure (cervical dilation)
Secondary outcomes (3)
Pain visual analogue scale (VAS)
Pain as measured on a 100 mm visual analogue scale (VAS). Full scale scored from 0-100, higher score indicates more pain..
Measured: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Patient Satisfaction
Full scale scored from 0-100, higher score indicates (better or poorer) health outcomes.
Measured: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Frequency of procedure termination
Number of times of procedure termination
Measured: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To study the effect of a combined ketorolac and lidocaine paracervical block on procedure related pain with office hysteroscopy. The standard of care is currently just a lidocaine paracervical block.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Ascher-Walsh, Icahn School of Medicine at Mount Sinai
- Investigators
- Charles Ascher-Walsh, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653400
- Sponsor's protocol ID
- STUDY-23-01631
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.