Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
Healthy Volunteers
ID06653400

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-10-31

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial investigates how a combined ketorolac and lidocaine paracervical block compares to a standard lidocaine paracervical block in managing pain during office hysteroscopy procedures. The study is randomized, double-blind, and placebo-controlled, aiming to better understand pain relief and patient satisfaction during this common gynecological procedure. It also evaluates safety by monitoring for major adverse events associated with the combined block. Participants will be randomly assigned to receive either a paracervical block with 20 mL of 1% lidocaine alone or the same lidocaine dose combined with 2 mL (30 mg) of ketorolac. The office hysteroscopy is performed following the block, and the study spans two years to assess outcomes over time. The trial is conducted at Mount Sinai Hospital, focusing on patients booked for office hysteroscopy. During the study, pain is measured using a 100 mm visual analogue scale at several points: during cervical dilation, during the block, during the hysteroscopy, immediately after, and 30 minutes post-procedure. Patient satisfaction and procedure termination rates are also recorded. The trial includes safety monitoring for adverse events and follows participants throughout the full study duration to gather comprehensive data on pain control and overall patient experience.

CONDITIONS

Brief Title

Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients assigned female at birth
  • Booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single procedure day

Participants receive a paracervical block with either lidocaine alone or lidocaine combined with ketorolac during office hysteroscopy to assess procedure-related pain.

1 visit (in-person)

Follow-up

Duration - 30 minutes after procedure

Participants are observed immediately after the procedure and 30 minutes later to assess pain levels, patient satisfaction, and any adverse events.

2 visits (immediate post-procedure and 30 minutes after)

Trial Site Locations

Total: 1 location

1

Mount Sinai

New York, New York, United States, 10029

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Research Team

K

Kathleen E Ackert, DO

V

Virginia H Flatow, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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