Trial Title:
Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy
NCT ID:
NCT05967936
Condition:
Myoma;Uterus
Polyp Uterus
Conditions: Official terms:
Leiomyoma
Myofibroma
Bupivacaine
Conditions: Keywords:
hysteroscopy
pain
local anesthetic
ambulatory care
bupivacaine
paracervical block
transcervical block
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Bupivacaine Injection
Description:
evaluation of pain by using two different types of local anesthesia
Arm group label:
Paracervical block
Arm group label:
Transcervical block
Other name:
evaluation of pain by using two different types of local anesthesia
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CIUSSS de l'Est de l'Île de Montréal
Address:
City:
Montréal-Est
Zip:
H1T 2M4
Country:
Canada
Contact:
Last name:
Janey Fang, MD
Phone:
5142513051
Email:
jfang85@uwo.ca
Contact backup:
Last name:
Chantal Rivard, MD
Phone:
5142513051
Email:
rivardch@videotron.ca
Investigator:
Last name:
Paz Garcia, MD
Email:
Principal Investigator
Investigator:
Last name:
Mélissa Roy, MD
Email:
Principal Investigator
Investigator:
Last name:
Janey Fang, MD
Email:
Principal Investigator
Investigator:
Last name:
Chantal Rivard, MD
Email:
Sub-Investigator
Investigator:
Last name:
Émilie Hudon, MD
Email:
Sub-Investigator
Investigator:
Last name:
Émilie Gorak, MD
Email:
Sub-Investigator
Investigator:
Last name:
Mik Gangal, MD
Email:
Sub-Investigator
Start date:
September 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Ciusss de L'Est de l'Île de Montréal
Agency class:
Other
Collaborator:
Agency:
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
Agency class:
Other
Source:
Ciusss de L'Est de l'Île de Montréal
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05967936
