NCT05801172

Brief Summary

Hysteroscopy is a reference diagnostic and therapeutic procedure in intrauterine pathologies, increasingly performed without general anesthesia. Pain is the most common reason for discontinuation of outpatient hysteroscopy (OH). There is no consensus on pain alleviation during OH. The aim was to compare the effectiveness of pain relief options during OH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

March 11, 2023

Last Update Submit

August 6, 2023

Conditions

PainHysteroscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Intensification of pain in Numeric Rating Scale: 0-10

    Measurement and comparison of the intensity of pain in numeric rating scale (NRS) during and after the procedure in 3 study arms

    up to 6 months

Secondary Outcomes (3)

  • Intensity of cervical bleeding on the assumed scale: 0-3

    up to 6 months

  • Occurrence of vaso-vagal reaction during the procedure

    up to 6 months

  • Occurrence of abandoning/ limiting the procedure

    up to 6 months

Study Arms (3)

A (NSAID)

ACTIVE COMPARATOR

ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy

Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopyProcedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy

B (A+infiltration anesthesia)

ACTIVE COMPARATOR

ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure

Procedure: ketoprofen for pain relief in office hysteroscopyProcedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy

C (A+paracervical block)

ACTIVE COMPARATOR

ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy 20 ml 1% lidocaine in pericervical administration at the start of the procedure

Procedure: ketoprofen for pain relief in office hysteroscopyProcedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy

Interventions

ketoprofen for pain relief in office hysteroscopyPROCEDURE

ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy

B (A+infiltration anesthesia)C (A+paracervical block)
ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopyPROCEDURE

ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure

A (NSAID)C (A+paracervical block)
ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopyPROCEDURE

ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy plus 20 ml 1% lidocaine in paracervical block at the start of the procedure

A (NSAID)B (A+infiltration anesthesia)

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 18
  • indications for hysteroscopy: focal uterine lesion, abnormal uterine bleeding, or infertility

You may not qualify if:

  • allergies to medications
  • refusal to consent to the procedure or participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

Location

MeSH Terms

Conditions

Pain

Interventions

KetoprofenAnalgesiaAnesthesia, LocalLidocaineAnesthesia, Obstetrical

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAnesthesia and AnalgesiaAnesthesia, ConductionAnesthesiaAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Robert Jach, Prof.

    Jagiellonian University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D., Principal Investigator

Study Record Dates

First Submitted

March 11, 2023

First Posted

April 6, 2023

Study Start

July 1, 2022

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)