Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

NCT06653400 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY-23-01631
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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.

  during procedure (cervical dilation)

Secondary Outcomes (3)

• Pain visual analogue scale (VAS)

  with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure

• Patient Satisfaction

  with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure

• Frequency of procedure termination

  with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure

Study Arms (2)

Lidocaine alone

PLACEBO COMPARATOR

Paracervical block will be performed with just lidocaine

Procedure: paracervical block; Drug: Lidocaine

Lidocaine plus ketorolac

EXPERIMENTAL

Paracervical block will be performed with lidocaine plus ketorolac

Procedure: paracervical block; Drug: Lidocaine; Drug: ketorolac

Interventions

paracervical block PROCEDURE

paracervical block with office hysteroscopy

Lidocaine alone; Lidocaine plus ketorolac

Lidocaine DRUG

Dosage: 20 mL of 1% lidocaine

Lidocaine alone; Lidocaine plus ketorolac

ketorolac DRUG

Dosage: 2 mL (30 mg) of ketorolac

Lidocaine plus ketorolac

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients assigned female at birth,
• booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Metrorrhagia; Agnosia

Interventions

Anesthesia, Obstetrical; Lidocaine; Ketorolac

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Charles Ascher-Walsh, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen E Ackert, DO

CONTACT

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

Virginia H Flatow, MD

CONTACT

virginia.flatow@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: An assistant will be in charge of mixing either the intervention or control paracervical block. The physician performing the procedure and the patient will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: February 27, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

US (1)