Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

Mount Sinai Health System

Status and phase: Enrolling; Phase 1

Conditions: Analgesia; Paracervical Block; Abnormal Uterine Bleeding

Treatments: Procedure: paracervical block; Drug: ketorolac; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06653400

STUDY-23-01631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Lidocaine alone

Placebo Comparator group

Description:

Paracervical block will be performed with just lidocaine

Treatment:

Drug: Lidocaine

Procedure: paracervical block

Lidocaine plus ketorolac

Experimental group

Description:

Paracervical block will be performed with lidocaine plus ketorolac

Treatment:

Drug: Lidocaine

Drug: ketorolac

Procedure: paracervical block