Managing Outpatient Hysteroscopy-associated Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Hysteroscopic Surgery

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A (NSAID)<br>ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy | Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy<br>* 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<br>Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy<br>* 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<br>|
| Active Comparator: B (A+infiltration anesthesia)<br>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<br>* ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy<br>Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy<br>* 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<br>|
| Active Comparator: C (A+paracervical block)<br>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<br>* ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy<br>Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy<br>* 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<br>|

What is the study measuring?
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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 |