Hysteroscopy Procedural Pain
Conditions
Interventions
This is a randomized, double-blind clinical trial with two groups composed of female patients from the outpatient hysteroscopy clinic of a public hospital. In the intervention group, 5 ml of 2% lidoca
s diagnostic sheath at the beginning of the outpatient hysteroscopy procedure using a 3 mm diameter Mistra-type instrument, a single physician will perform all procedures. Blinding was achieved by del
Sponsors
Sociedade Benef Israelita Bras Hospital Albert Einstein
Hospital Municipal Vila santa Catarina
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: All patients seen at the Office Hysteroscopy service of the Vila Santa Catarina Municipal Hospital until the number of 140 patients with complete data is reached, regardless of the clinical condition presented for evaluation of the uterine cavity; who have signed and agreed to the Informed Consent Form
Exclusion criteria
Exclusion criteria: Patients with known hypersensitivity to amide-type local anesthetics or, more specifically, to lidocaine hydrochloride; who present with insurmountable cervical stenosis during the procedure; patients with a history of cervical or endometrial cancer; and patients with a history of cervical surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intrauterine lidocaine administration is expected to reduce pain and discomfort during and after outpatient hysteroscopy, improving patient and physician satisfaction and the procedure's success rate. The outcome will be assessed by directly applying a visual analog pain scale to the patient immediately after the procedure, 10 and 30 minutes after the procedure. Data will be statistically described in terms of mean ± standard deviation, median and range, or frequencies (number of cases) and percentages when appropriate. Comparison of numerical variables between groups will be performed using the Student's t-test for independent samples. For comparison of categorical data, the Chi-square test will be used. Fisher's exact test will be applied when the expected frequency is less than 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| The presence of complications will be verified (occurrence of vagal reaction or need to interrupt the procedure before its completion due to intense pain in the patient), resolution (how many patients needed to be referred for surgical hysteroscopy), time for execution and evaluation of the patient's vital signs (heart rate and blood pressure) at the beginning and end of the procedure | — |
Countries
BR
Contacts
Public ContactDebora Maranhao
Albert Einstein Hospital Israelita
Outcome results
None listed