Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abnormal Uterine Bleeding Analgesia Paracervical Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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Lidocaine alone

Paracervical block will be performed with just lidocaine

Group Type PLACEBO_COMPARATOR

paracervical block

Intervention Type PROCEDURE

paracervical block with office hysteroscopy

Lidocaine

Intervention Type DRUG

Dosage: 20 mL of 1% lidocaine

Lidocaine plus ketorolac

Paracervical block will be performed with lidocaine plus ketorolac

Group Type EXPERIMENTAL

paracervical block

Intervention Type PROCEDURE

paracervical block with office hysteroscopy

Lidocaine

Intervention Type DRUG

Dosage: 20 mL of 1% lidocaine

ketorolac

Intervention Type DRUG

Dosage: 2 mL (30 mg) of ketorolac

Interventions

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paracervical block

paracervical block with office hysteroscopy

Intervention Type PROCEDURE

Lidocaine

Dosage: 20 mL of 1% lidocaine

Intervention Type DRUG

ketorolac

Dosage: 2 mL (30 mg) of ketorolac

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes