NCT05801172

Managing Outpatient Hysteroscopy-associated Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Hysteroscopic Surgery

Interventions

Type	Name	Description
PROCEDURE	ketoprofen for pain relief in office hysteroscopy	ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy
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
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

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2023-04-06
• Last updated: 2023-08-08

Locations

1 site across 1 country: Poland