Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy

Study Overview
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Brief Summary
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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: Cervical/ intracervical block: injection of local anesthetic into the four quadrants of the cervix. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5 and 7 o'clock positions. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via catheter through the cervix and into the uterine cavity. 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
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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.

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

Conditions
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Myoma;Uterus, Polyp Uterus

Intervention / Treatment
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* Drug: Bupivacaine Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracervical block<br>10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total). | Drug: Bupivacaine Injection<br>* evaluation of pain by using two different types of local anesthesia<br>* Other names: evaluation of pain by using two different types of local anesthesia;|
| Experimental: Transcervical block<br>10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter | Drug: Bupivacaine Injection<br>* evaluation of pain by using two different types of local anesthesia<br>* Other names: evaluation of pain by using two different types of local anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy | 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 | during hysteroscopy | 
| To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy | 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 | 15 minutes post hysteroscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients | Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients | during hysteroscopy | 
| Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients | Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients | 15 minutes post hysteroscopy | 
| Compare the pain experience based on the visual analogue scale between nulliparous and parous patients | Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients | during hysteroscopy | 
| Compare the pain experience based on the visual analogue scale between nulliparous and parous patients | Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients | 15 minutes post hysteroscopy | 
| To evaluate the need for an extra intravenous sedative dose. | Number of patients who demand an extra dose of sedative during hysteroscopy | during hysteroscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysteroscopy, pain, local anesthetic, ambulatory care, bupivacaine, paracervical block, transcervical block