Managing Outpatient Hysteroscopy-associated Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hysteroscopic Surgery
• Intervention / Treatment: 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; Procedure: ketoprofen for pain relief in office hysteroscopy

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 Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland, 31-501
    • Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 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; Procedure: ketoprofen for pain relief in office hysteroscopy; ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy
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 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 for pain relief in office hysteroscopy; ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Ketoprofen
• Other Study ID Numbers: 1072.6120.228.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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