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Completed

NCT Number: NCT05801172

Managing Outpatient Hysteroscopy-associated Pain

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.

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Key information

Conditions

Pain Hysteroscopic Surgery Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketoprofen for pain relief in office hysteroscopy

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

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

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

Primary outcomes

  1. Intensification of pain in Numeric Rating Scale: 0-10

    Time frame: up to 6 months

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

Secondary outcomes

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

    Time frame: up to 6 months

    Measurement and comparison of the intensity of cervical bleeding (intensity scale: 0-3) during the procedure in 3 study arms

  2. Occurrence of vaso-vagal reaction during the procedure

    Time frame: up to 6 months

    Measurement and comparison of the frequency of vaso-vagal reaction during the procedure in 3 study arms

  3. Occurrence of abandoning/ limiting the procedure

    Time frame: up to 6 months

    Measurement and comparison of the frequency of abandoning/ limiting the procedure due to pain in 3 study arms

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Relieving Outpatient Hysteroscopy-associated Pain: What is the Most Effective Method?

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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