Clinical trial NCT06653400: Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Official title: Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Abnormal Uterine Bleeding
Analgesia
Paracervical Block
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To study the effect of a combined ketorolac and lidocaine paracervical block on procedure related pain with office hysteroscopy. The standard of care is currently just a lidocaine paracervical block.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Pain visual analogue scale (VAS)
timeFrame: during procedure (cervical dilation)
Secondary outcomes:
measure: Pain visual analogue scale (VAS)
timeFrame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
measure: Patient Satisfaction
timeFrame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
measure: Frequency of procedure termination
timeFrame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Charles Ascher-Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References: