Abnormal Uterine Bleeding, Analgesia, Paracervical Block
Conditions
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.
Interventions
DRUGketorolac
Dosage: 2 mL (30 mg) of ketorolac
DRUGLidocaine
Dosage: 20 mL of 1% lidocaine
PROCEDUREparacervical block
paracervical block with office hysteroscopy
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
An assistant will be in charge of mixing either the intervention or control paracervical block. The physician performing the procedure and the patient will be blinded to the intervention.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain visual analogue scale (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain visual analogue scale (VAS) | 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.. |
| Patient Satisfaction | 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. |
| Frequency of procedure termination | with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure | Number of times of procedure termination |
Countries
United States
Contacts
Primary ContactKathleen E Ackert, DO
Backup ContactVirginia H Flatow, MD
Outcome results
None listed