Managing Outpatient Hysteroscopy-associated Pain
- Conditions
- Hysteroscopic SurgeryPain
- Registration Number
- NCT05801172
- Lead Sponsor
- Jagiellonian University
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 201
- age over 18
- indications for hysteroscopy: focal uterine lesion, abnormal uterine bleeding, or infertility
- allergies to medications
- refusal to consent to the procedure or participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Intensification of pain in Numeric Rating Scale: 0-10 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 Outcome Measures
Name Time Method Intensity of cervical bleeding on the assumed scale: 0-3 up to 6 months Measurement and comparison of the intensity of cervical bleeding (intensity scale: 0-3) during the procedure in 3 study arms
Occurrence of vaso-vagal reaction during the procedure up to 6 months Measurement and comparison of the frequency of vaso-vagal reaction during the procedure in 3 study arms
Occurrence of abandoning/ limiting the procedure up to 6 months Measurement and comparison of the frequency of abandoning/ limiting the procedure due to pain in 3 study arms
Trial Locations
- Locations (1)
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
🇵🇱Krakow, Poland
Jagiellonian University Medical College, Department of Gynecology and Obstetrics🇵🇱Krakow, Poland