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Anesthetics

Bupivacaine

Anesthetics, Local

10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).

10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter

evaluation of pain by using two different types of local anesthesia

Bupivacaine Injection

Janey Fang, MD

Chantal Rivard, MD

Paz Garcia, MD

Mélissa Roy, MD

Émilie Hudon, MD

Émilie Gorak, MD

Mik Gangal, MD

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.

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.

Multicentric, prospective, randomized trial, single-blinded, where eligible patients will be randomized to either receive paracervical or transcervical anesthesia before outpatient surgical hysteroscopy

Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy

A Prospective Randomized Study Comparing Different Types of Local Anesthesia in Outpatient Procedural Hysteroscopy

There is not a plan to make IPD available

comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block

Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients

Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients

Number of patients who demand an extra dose of sedative during hysteroscopy

Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Ciusss de L'Est de l'Île de Montréal

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Infertility

Tissue Adhesions

Septate Uterus

Genital Diseases

Urogenital Diseases

Pathological Conditions, Anatomical

Cicatrix

Fibrosis

Congenital Abnormalities

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Application of Hyalobarrier® gel endo immediate after the complete hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception + application of sterile ultrasound gel into the vagina (to blind all trial participants, fertility physicians and gynaecologists doing second-look hysteroscopy)

No application of Hyalobarrier® gel endo after the hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception + application of sterile ultrasound gel into the vagina (to blind all trial participants, fertility physicians and gynaecologists doing second- or third-look hysteroscopy)

Intra-uterine application of 10ml sterile gel containing 30mg APC. It will be administered once, peroperatively immediate after the complete hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception

Hyalobarrier® gel endo

Steven Weyers, MD,PhD

To compare the costs and effects of HYALOBARRIER® GEL ENDO versus no HYALOBARRIER® GEL ENDO for increasing the chance of conception leading to live birth measured at 30 weeks after randomization in women wishing to become pregnant after surgical removal of intrauterine pathology (endometrial polyps, fibroids with uterine cavity deformation, uterine septa, IUAs or RPOC after miscarriage) by hysteroscopy as an outpatient or in hospital treatment.

Design:

Multi-centre, parallel group, superiority, double-blind, randomized controlled trial. Post market study of a Medical Device class III.

Participant:

Women aged 18 to 47 years attending Belgian gynaecological departments, scheduled for operative hysteroscopy for endometrial polyps, fibroids with uterine cavity deformation, uterine septa, intrauterine adhesions (IUAs) or retained products of conception, and wishing to conceive spontaneously or before fertility treatment with ovulation induction (OI), controlled ovarian stimulation (COS), intrauterine insemination (IUI) or IVF/ICSI.

Treatment:

Application of Hyalobarrier® gel endo at time of surgery

Control:

No application of Hyalobarrier® gel endo

Follow up:

short term follow-up: 30 weeks after receiving the treatment allocation long term follow-up: 66 weeks after receiving the treatment allocation

To blind all trial participants, fertility physicians and gynaecologists doing second- or third-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.

None of the participants will be informed of the allocated treatment by the surgeon performing the operative hysteroscopy or the personnel present in the OR. The medical record will not reveal any information whether HYALOBARRIER® GEL ENDO was applied at the end of the procedure. The REDCap software will automatically document the allocation and store all the records and the randomisations. The gynaecologist doing the operative hysteroscopy should not be the same as the fertility physician and the gynaecologist doing the second look hysteroscopy. In the exceptional case that the surgeon doing the operative hysteroscopy is the same person as the fertility physician or the gynaecologist doing the second-look hysteroscopy, blinding is assured by notification of treatment allocation if the surgeon has left the operating room.

HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outcome in Women With Intrauterine Pathology Wishing to Become Pregnant

The Cost-effectiveness of Anti-adhesion Treatment With HYALOBARRIER® GEL ENDO Versus no Gel Following the Removal by Hysteroscopy of Endometrial Polyps, Fibroids With Uterine Cavity Deformation, Uterine Septa, Intrauterine Adhesions or Retained Products of Conception for Improving Reproductive Outcome in Women Wishing to Become Pregnant: a Multi-centre, Parallel Group, Superiority, Double-blind, Randomized Controlled Trial

the amount of clinical pregnancies at 30 weeks after randomisation, leading to live birth (at least one live foetus after 20 weeks of gestation, that resulted in at least one live baby (the investigators counted the delivery of singleton, twin or multiple pregnancies as one live birth)

the time from receiving the allocated treatment to the date of conception

a spontaneous loss of pregnancy before 20 completed weeks of gestational age, or if gestational age is unknown, the loss of an embryo/fetus of less than 400 grams

a pregnancy in which implantation takes place outside the uterine cavity

The severity will be scored according to the revised American Fertility Society (AFS) scoring system

Pre-eclampsia in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

Preterm birth in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

Stillbirth in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

low/very low birth weight (gram) in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

caesarean section rates in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy	NCT05967936	Myoma;Uterus Polyp Uterus	Bupivacaine Inj...	18 Years -	Ciusss de L'Est de l'Île de Montréal
Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy	NCT05967936	Myoma;Uterus Polyp Uterus	Bupivacaine Inj...	18 Years -	Ciusss de L'Est de l'Île de Montréal
HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outcome in Women With Intrauterine Pathology Wishing to Become Pregnant	NCT03880435	Infertility Polyp Uterus Myoma;Uterus Adhesion Hysteroscopy Uterine Septum Retained Produc...	Hyalobarrier® g...	18 Years - 47 Years	University Hospital, Ghent
HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outcome in Women With Intrauterine Pathology Wishing to Become Pregnant	NCT03880435	Infertility Polyp Uterus Myoma;Uterus Adhesion Hysteroscopy Uterine Septum Retained Produc...	Hyalobarrier® g...	18 Years - 47 Years	University Hospital, Ghent

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