Managing Outpatient Hysteroscopy-associated Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05801172
• Other study ID #: 1072.6120.228.2021
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysteroscopic Surgery
• Pain

Intervention

Procedure:
• ketoprofen for pain relief in office hysteroscopy
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
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
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

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College, Department of Gynecology and Obstetrics	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensification of pain in Numeric Rating Scale: 0-10	Measurement and comparison of the intensity of pain in numeric rating scale (NRS) during and after the procedure in 3 study arms	up to 6 months
Secondary	Intensity of cervical bleeding on the assumed scale: 0-3	Measurement and comparison of the intensity of cervical bleeding (intensity scale: 0-3) during the procedure in 3 study arms	up to 6 months
Secondary	Occurrence of vaso-vagal reaction during the procedure	Measurement and comparison of the frequency of vaso-vagal reaction during the procedure in 3 study arms	up to 6 months
Secondary	Occurrence of abandoning/ limiting the procedure	Measurement and comparison of the frequency of abandoning/ limiting the procedure due to pain in 3 study arms	up to 6 months