Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

Phase 1

Recruiting

• Conditions: Abnormal Uterine Bleeding; Analgesia; Paracervical Block
• Interventions: Procedure: paracervical block; Drug: Lidocaine; Drug: ketorolac

• Registration Number: NCT06653400
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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 offic...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-20
• Study First Submitted QC: 2024-10-20
• Last Update Submitted: 2024-10-20
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22
• Study Start: 2024-11
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• Patients assigned female at birth,
• booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine alone	Lidocaine	Paracervical block will be performed with just lidocaine
Lidocaine plus ketorolac	paracervical block	Paracervical block will be performed with lidocaine plus ketorolac
Lidocaine plus ketorolac	Lidocaine	Paracervical block will be performed with lidocaine plus ketorolac
Lidocaine plus ketorolac	ketorolac	Paracervical block will be performed with lidocaine plus ketorolac
Lidocaine alone	paracervical block	Paracervical block will be performed with just lidocaine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mount Sinai; 🇺🇸 New York, New York, United States