Managing Outpatient Hysteroscopy-associated Pain

Not Applicable

Completed

• Conditions: Hysteroscopic Surgery; Pain
• Interventions: Procedure: ketoprofen for pain relief in office hysteroscopy; Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy; Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy

• 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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-06
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (NSAID)	ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy	ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy
C (A+paracervical block)	ketoprofen for pain relief in office hysteroscopy	ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy 20 ml 1% lidocaine in pericervical administration at the start of the procedure
A (NSAID)	ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy	ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy
B (A+infiltration anesthesia)	ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy	ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure
B (A+infiltration anesthesia)	ketoprofen for pain relief in office hysteroscopy	ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure
C (A+paracervical block)	ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy	ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy 20 ml 1% lidocaine in pericervical administration at the start of the procedure

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