Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: paracervical block, Lidocaine, ketorolac.
- Who it may be relevant to
- Registry conditions: Abnormal Uterine Bleeding, Analgesia, Paracervical Block. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy: a Randomized Controlled Trial
Overview
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.
Interventions
- Procedure paracervical block
paracervical block with office hysteroscopy - Drug Lidocaine
Dosage: 20 mL of 1% lidocaine - Drug ketorolac
Dosage: 2 mL (30 mg) of ketorolac
Primary outcome measures
- Pain visual analogue scale (VAS) [Time frame: during procedure (cervical dilation)]
Secondary outcome measures (3)
- Pain visual analogue scale (VAS) [Time frame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure]
- Patient Satisfaction [Time frame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure]
- Frequency of procedure termination [Time frame: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mount Sinai — New York
Identifiers
NCT: NCT06653400 · STUDY-23-01631