Managing Outpatient Hysteroscopy-associated Pain

NCT ID: NCT05801172

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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A prospective randomized trial (consent no.1072.6120.228.2021) includes women subjected to OH due to focal uterine lesion, abnormal uterine bleeding, or infertility. 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). Karl Storz 5.0 mm Bettocchi® operative sheath with 2.9 mm 30 degree telescope and 5 Fr working channel was used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding, frequency of vaso-vagal reaction, and frequency of abandoning/ limiting the procedure were compared.

Conditions

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Pain Hysteroscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A (NSAID)

ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

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

B (A+infiltration anesthesia)

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

Group Type ACTIVE_COMPARATOR

ketoprofen for pain relief in office hysteroscopy

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

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

C (A+paracervical block)

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

Group Type ACTIVE_COMPARATOR

ketoprofen for pain relief in office hysteroscopy

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

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

Interventions

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ketoprofen for pain relief in office hysteroscopy

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

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* allergies to medications
* refusal to consent to the procedure or participation in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Iwona Magdalena Gawron

Ph.D., Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Jach, Prof.

Role: STUDY_CHAIR

Jagiellonian University

Locations

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Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, , Poland

Site Status

Countries

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Poland

Other Identifiers

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1072.6120.228.2021

Identifier Type: -

Identifier Source: org_study_id

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