Recruiting
Phase 1

Ketorolac & Lidocaine

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06653400

Conditions

Abnormal Uterine Bleeding

Analgesia

Paracervical Block

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

paracervical block

Lidocaine

ketorolac

Study Details

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.

Conditions

Abnormal Uterine Bleeding

Analgesia

Paracervical Block

Study ID

NCT06653400

Start date

Feb 27, 2025

Status verified date

Sep, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Lidocaine alone

Paracervical block will be performed with just lidocaine

experimental: Lidocaine plus ketorolac

Paracervical block will be performed with lidocaine plus ketorolac

Interventions

paracervical block

paracervical block with office hysteroscopy

Lidocaine

Dosage: 20 mL of 1% lidocaine

ketorolac

Dosage: 2 mL (30 mg) of ketorolac

Primary outcome measure

  • Pain visual analogue scale (VAS) [ Time Frame: during procedure (cervical dilation) ]

Central Contacts and Locations

Central contacts

Kathleen E Ackert, DO

212-241-4500kathleen.ackert@mssm.edu

Virginia H Flatow, MD

virginia.flatow@mssm.edu

Locations

Mount Sinai

Recruiting

New York, New York, United States, 10029

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 31, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-10-31.