Clinical trial NCT05967936: Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy
Official title: A Prospective Randomized Study Comparing Different Types of Local Anesthesia in Outpatient Procedural Hysteroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myoma;Uterus
Polyp Uterus
Keywords: hysteroscopy
pain
local anesthetic
ambulatory care
bupivacaine
paracervical block
transcervical block
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
Collaborators: name: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
First posted: 2023-08-01
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric, prospective, randomized trial, single-blinded, where eligible patients will be randomized to either receive paracervical or transcervical anesthesia before outpatient surgical hysteroscopy
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hysteroscopy is a minimally invasive, diagnostic and therapeutic gynecological surgical technique and the gold standard in the study of the uterine cavity. Thanks to the decrease in the diameter of hysteroscopes and to the vaginoscopic approach, anesthesia is no longer necessary in diagnostic hysteroscopy. Nevertheless, in operative hysteroscopy, given the instrumentalization and the need of cervical dilation, the use of local anesthesia, with or without sedation, is recommended. The different alternatives described in the literature are the following:

1. Cervical/ intracervical block: injection of local anesthetic into the four quadrants of the cervix.
2. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5 and 7 o'clock positions.
3. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via catheter through the cervix and into the uterine cavity.
4. Topical cervical anesthesia: application of local anesthetic in gel or spray to the cervix.

To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a prospective multicentric study that compare two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.

Detailed description: To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a multicentric prospective randomized trial, single-blinded, that compares two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.

The population studied will consist in adult women with indication of an outpatient surgical hysteroscopy (myomectomy or polypectomy). Every one of them will be invited to participate the day of their procedure. In the outpatient hysteroscopy clinic, the investigators will verify inclusion and exclusion criteria, explain the objectives of the study, collect data and obtain the patient's consent.

The sample size is 242 patients (121 in each group). The study will be performed in two different centers:

* Integrated University Health Center and Social Services of the East of the Island of Montreal
* Integrated University Health Center and social services of the South Center of the Island of Montreal

Right before each procedure the patients will be randomized through anonymous and alternized enveloppes that will be distributed in each center, to either receive paracervical or transcervical anesthesia before hysteroscopy.

Each patient will receive a pre-established dose of sedative before the procedure, according to their weight: Fentanyl 0,5 mcg/kg IV and Midazolam 0,02 mg/kg. The subsequent doses will be noted.

Under sedation, with the patient in lithotomy position, a medium size speculum will be inserted. The vagina will be disinfected with chlorhexidine and the anterior lip of the cervix will be gripped with a Pozzi forceps.

According to previous randomization, each patient will receive one of the following alternatives of local anesthesia:

* Group A: Paracervical 10cc Bupivacaine 1%, without epinephrine, at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).
* Group B: Transcervical (uterine) 10cc Bupivacaine 1% through the endocervix using an 17-Gauge epidural catheter

During the procedure (T1), the nurse will be in charge to fill the scale (to avoid bias). The patients will be given a Visual Analogue Scale (VAS) to fill 15 minutes after the procedure (before discharge), to assess pain.

For each group the investigators will calculate the average rate of pain according to the Visual Analogue Scale during and immediately after the procedure (15 minutes). The investigators will subdivide each group into pre and postmenopausal women and into nulliparous and parous women and compare their Visual Analogue Scale as well.

Statistical analysis will be performed to compare results.

Eligibility criteria: Inclusion Criteria:

* Female patients
* 18 years of age or older
* Indication of outpatient surgical hysteroscopy for polypectomy and myomectomy

Exclusion Criteria:

* Women under 18 years old
* Unable to understand how to score a visual analog scale pain score
* Hysteroscopy contraindication
* Patients with medical history or current status that makes outpatient procedure usafe

Primary outcomes:
measure: To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy
timeFrame: during hysteroscopy
measure: To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy
timeFrame: 15 minutes post hysteroscopy
Secondary outcomes:
measure: Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients
timeFrame: during hysteroscopy
measure: Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients
timeFrame: 15 minutes post hysteroscopy
measure: Compare the pain experience based on the visual analogue scale between nulliparous and parous patients
timeFrame: during hysteroscopy
measure: Compare the pain experience based on the visual analogue scale between nulliparous and parous patients
timeFrame: 15 minutes post hysteroscopy
measure: To evaluate the need for an extra intravenous sedative dose.
timeFrame: during hysteroscopy
Other outcomes:
Locations:
city: Montréal-Est
country: Canada
facility: CIUSSS de l'Est de l'Île de Montréal
state: Quebec
Study officials:
affiliation: OB-GYN
name: Mélissa Roy, MD
role: STUDY_DIRECTOR
References:
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