Managing Outpatient Hysteroscopy-associated Pain

• Sponsor: Jagiellonian University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05801172
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 13.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Hysteroscopic Surgery	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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).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).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Relieving Outpatient Hysteroscopy-associated Pain: What is the Most Effective Method?
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A (NSAID) ketoprofen 100 mg intravenously 30 min. pre-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
Active Comparator: B (A+infiltration anesthesia) ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure	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 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
Active Comparator: C (A+paracervical block) ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy 20 ml 1% lidocaine in pericervical administration at the start of the procedure	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jagiellonian University Medical College, Department of Gynecology and Obstetrics	Krakow		Poland	31-501

Sponsors and Collaborators

• Jagiellonian University

Investigators

• Study Chair: Robert Jach, Prof., Jagiellonian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iwona Magdalena Gawron, Ph.D., Principal Investigator, Jagiellonian University
• ClinicalTrials.gov Identifier: NCT05801172
• Other Study ID Numbers: 1072.6120.228.2021
• First Posted: Apr 6, 2023
• Last Update Posted: Apr 6, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Ketoprofen; Lidocaine; Anesthetics

Study Results

No Results Posted as of Apr 6, 2023