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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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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
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
Show all 9Show fewer
  • 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.

United States1 site
  • Mount Sinai

    New York, New York, 10029

Other trials in United States

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.

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 groups in NCT06653400
Study groupRoleWhat they receive
Lidocaine alonePlacebo comparatorParacervical block will be performed with just lidocaine
Receives: Procedure: paracervical block; Drug: Lidocaine
Lidocaine plus ketorolacExperimentalParacervical 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted22 Oct 2024
  2. Study start1 Jul 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
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.

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