Mount Sinai
New York, 10029, United States
Location status: Recruiting
Location contact
Charles Ascher-Walsh, MD
CONTACT
Kathleen E Ackert
SUB_INVESTIGATOR
Virginia Flatow, MD
CONTACT
NCT Number: NCT06653400
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 1
New York, 10029, United States
Location status: Recruiting
Charles Ascher-Walsh, MD
CONTACT
Kathleen E Ackert
SUB_INVESTIGATOR
Virginia Flatow, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
paracervical block with office hysteroscopy
Dosage: 20 mL of 1% lidocaine
Dosage: 2 mL (30 mg) of ketorolac
Time frame: during procedure (cervical dilation)
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.
Time frame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Pain as measured on a 100 mm visual analogue scale (VAS). Full scale scored from 0-100, higher score indicates more pain..
Time frame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Full scale scored from 0-100, higher score indicates (better or poorer) health outcomes.
Time frame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Number of times of procedure termination
Contact information is provided by the study sponsor or research team.
Kathleen E Ackert, DO
CONTACT
Virginia H Flatow, MD
CONTACT
Icahn School of Medicine at Mount Sinai
Other
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy: a Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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