Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Abnormal Uterine Bleeding; Paracervical Block
• Intervention / Treatment: Procedure: paracervical block; Drug: Lidocaine; Drug: ketorolac

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kathleen E Ackert, DO; Phone Number: 212-241-4500; Email: kathleen.ackert@mssm.edu
• Study Contact Backup: Name: Virginia H Flatow, MD; Email: virginia.flatow@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai
      • Contact: Charles Ascher-Walsh, MD
      • Contact: Virginia Flatow, MD
      • Sub-Investigator: Kathleen E Ackert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Lidocaine alone; Paracervical block will be performed with just lidocaine	Procedure: paracervical block; paracervical block with office hysteroscopy; Drug: Lidocaine; Dosage: 20 mL of 1% lidocaine
Experimental: Lidocaine plus ketorolac; Paracervical block will be performed with lidocaine plus ketorolac	Procedure: paracervical block; paracervical block with office hysteroscopy; Drug: Lidocaine; Dosage: 20 mL of 1% lidocaine; Drug: ketorolac; Dosage: 2 mL (30 mg) of ketorolac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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..	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.	with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Frequency of procedure termination	Number of times of procedure termination	with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 20, 2024
• First Submitted That Met QC Criteria: October 20, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neurobehavioral Manifestations; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Uterine Hemorrhage; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Metrorrhagia; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Indomethacin; Indoles; Anesthesia and Analgesia; Anesthesia; Ketorolac; Lidocaine; Anesthesia, Obstetrical
• Other Study ID Numbers: STUDY-23-01631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No