Pain relief during office hysteroscopy using a combined medication approach
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy: a Randomized Controlled Trial
This study is testing whether a combination of two pain medications can help women feel less pain during office hysteroscopy procedures compared to just one medication.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06653400 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combined ketorolac and lidocaine paracervical block compared to a standard lidocaine paracervical block in reducing pain during office hysteroscopy procedures. It is a randomized double-blind placebo-controlled trial that aims to assess not only the pain experienced during the procedure but also patient satisfaction and any potential adverse events. The primary endpoint focuses on pain levels measured on a visual analogue scale during cervical dilation, while secondary endpoints include pain at various stages of the procedure and overall patient satisfaction. The study is conducted at Mount Sinai Hospital, targeting patients assigned female at birth who are scheduled for office hysteroscopy.
Who should consider this trial
Good fit: Ideal candidates are patients assigned female at birth who are scheduled for office hysteroscopy at Mount Sinai Hospital.
Not a fit: Patients with allergies to ketorolac or lidocaine, or those with certain medical conditions such as chronic liver disease or acute renal failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve patient satisfaction during office hysteroscopy procedures.
How similar studies have performed: Other studies have shown promising results with similar analgesic approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Charles Ascher-Walsh, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Kathleen E Ackert, DO
- Email: kathleen.ackert@mssm.edu
- Phone: 212-241-4500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.