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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (NSAID) | Active Comparator | ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy |
|
| B (A+infiltration anesthesia) | Active Comparator | 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) | Active Comparator | ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy 20 ml 1% lidocaine in pericervical administration at the start of the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketoprofen for pain relief in office hysteroscopy | Procedure | ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Jach, Prof. | Jagiellonian University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University Medical College, Department of Gynecology and Obstetrics | Krakow | 31-501 | Poland |
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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).
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| ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy | Procedure | 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 | Procedure | 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 |
|
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 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007660 | Ketoprofen |
| D000698 | Analgesia |
| D000772 | Anesthesia, Local |
| D008012 | Lidocaine |
| D000773 | Anesthesia, Obstetrical |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000760 | Anesthesia and Analgesia |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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