Hysteroscopic Surgery, Pain
Conditions
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.
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.
Interventions
PROCEDUREketoprofen for pain relief in office hysteroscopy
ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy
PROCEDUREketoprofen 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
PROCEDUREketoprofen 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
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Poland
Outcome results
None listed