Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06653400
Phase
PHASE1
Status
Recruiting

Conditions

  • Abnormal Uterine Bleeding
  • Analgesia
  • Paracervical Block

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • paracervical block — PROCEDURE
    paracervical block with office hysteroscopy
  • Lidocaine — DRUG
    Dosage: 20 mL of 1% lidocaine
  • ketorolac — DRUG
    Dosage: 2 mL (30 mg) of ketorolac

Study Details

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.

Key Dates

Start date
Feb 27, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Lidocaine alone
    Paracervical block will be performed with just lidocaine
  • Experimental: Lidocaine plus ketorolac
    Paracervical block will be performed with lidocaine plus ketorolac

Primary Outcome Measure

Pain visual analogue scale (VAS) [ Time Frame: during procedure (cervical dilation) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount SinaiNew YorkNew York10029
Charles Ascher-Walsh, MD
Virginia Flatow, MD
Kathleen E Ackert (SUB_INVESTIGATOR)

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