Health TrialsbyHealthPanel

Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy

ConditionsAbnormal Uterine BleedingAnalgesiaParacervical Block
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients assigned female at birth,

booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates.

Disqualifiers

Allergy to ketorolac or non-steroidal anti-inflammatory medications

Allergy to lidocaine

Presence of thrombocytopenia

Contraindications to lidocaine

Trial design

Design model

Parallel

Treatments tested in this trial

  • paracervical block

    Procedure/Surgery

    paracervical block with office hysteroscopy

  • Lidocaine

    Drug

    Dosage: 20 mL of 1% lidocaine

  • ketorolac

    Drug

    Dosage: 2 mL (30 mg) of ketorolac

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Lidocaine alonePlacebo comparator 2 interventions
Group B: Lidocaine plus ketorolacExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pain visual analogue scale (VAS)

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.

Time frame
during procedure (cervical dilation)

Secondary outcomes

1

Pain visual analogue scale (VAS)

Pain as measured on a 100 mm visual analogue scale (VAS). Full scale scored from 0-100, higher score indicates more pain..

Time frame
with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
2

Patient Satisfaction

Full scale scored from 0-100, higher score indicates (better or poorer) health outcomes.

Time frame
with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
3

Frequency of procedure termination

Number of times of procedure termination

Time frame
with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov
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