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NCT Number: NCT06653400

Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Charles Ascher-Walsh, MD

CONTACT

Kathleen E Ackert

SUB_INVESTIGATOR

Virginia Flatow, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracervical block

Procedure

paracervical block with office hysteroscopy

Lidocaine

Drug

Dosage: 20 mL of 1% lidocaine

Ketorolac

Drug

Dosage: 2 mL (30 mg) of ketorolac

Primary outcomes

  1. Pain visual analogue scale (VAS)

    Time frame: during procedure (cervical dilation)

    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.

Secondary outcomes

  1. Pain visual analogue scale (VAS)

    Time frame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure

    Pain as measured on a 100 mm visual analogue scale (VAS). Full scale scored from 0-100, higher score indicates more pain..

  2. Patient Satisfaction

    Time frame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure

    Full scale scored from 0-100, higher score indicates (better or poorer) health outcomes.

  3. Frequency of procedure termination

    Time frame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure

    Number of times of procedure termination

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen E Ackert, DO

CONTACT

[email protected]

212-241-4500

Virginia H Flatow, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2024
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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