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ID06653400

Study of Combined Ketorolac and Lidocaine Paracervical Block to Reduce Pain During Office Hysteroscopy in Adult Women

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

60

Participants Needed

1

Research Sites

N/A

Total Duration

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

Research Team

K

Kathleen E Ackert, DO

V

Virginia H Flatow, MD

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