Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Pain

Polyps

Myoma

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Central Nervous System Depressants

All Drugs and Chemicals

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

Nervous System Diseases

Rare Diseases

Syndrome

Complex Regional Pain Syndromes

Reflex Sympathetic Dystrophy

Ganglion Cysts

Synovial Cyst

Cysts

Mucinoses

Autonomic Nervous System Diseases

Primary Dysautonomias

Peripheral Nervous System Diseases

Neuromuscular Diseases

Complex Regional Pain Syndrome

Ropivacaine

stellate ganglion block with ropivacaine 0.2% 5 mL

stellate ganglion block wit ropivacaine 0.2% 2 mL

Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.

Veronique Brulotte, MD

The purpose of this study is to compare the efficiency and safety of 2ml versus 5ml of local anesthetics used in stellate ganglion blocks for the treatment of complex regional pain syndrome of the arm.

To evaluate if 2ml of 0.2% ropivacaine is less effective in decreasing pain scores by more than 50% when compared to 5ml of 0.2% ropivacaine. To evaluate if 2ml of 0.2% ropivacaine is causes less side effects when compared to 5ml after a stellate ganglion block.

Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm

Comparison of Two Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for the Treatment of Complex Regional Pain Syndrome of the Arm

physician or patient identifying a neck hematoma

Evaluate the efficiency of stellate ganglion block in decreasing pain scores 24 hours after the procedure using a verbal numeric pain rating scale.

Evaluate the efficiency of stellate ganglion block in decreasing pain scores 7 days after the procedure using a verbal numeric pain rating scale.

Evaluate the efficiency of stellate ganglion block in decreasing pain scores 14 days after the procedure using a verbal numeric pain rating scale.

Evaluate the efficiency of stellate ganglion block on the increase in temperature of the ipsilateral arm using an infrared thermometer. The cutaneous temperature will be measured in order to determine the proportion of patients in each group reaching an increase of \>1.5 C in the ipsilateral arm.

Evaluate the efficiency of stellate ganglion block to produce an ipsilateral Horner Syndrome as defined by a ptosis and miosis. Evaluate the proportion of patients in each group presenting an ipsilateral Horner syndrome.

Patients describing having dysphagia after the stellate ganglion block

patients describing having hoarseness after a stellate ganglion block

patients describing having a foreign body sensation after the stellate ganglion block

patients describing having dyspnea after a stellate ganglion block

patients describing having ipsilateral arm weakness after a stellate ganglion block

Maisonneuve-Rosemont Hospital

MD, MSc, FRCPC

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hemorrhage

Uterine Hemorrhage

Pathological Conditions, Anatomical

Myomectomy for uterine polyps and/or fibroids occurring in an office setting

Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting

Myomectomy

Edward Evantash, MD

The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine polyps and submucosal fibroids.

Approximately one hundred subjects will be enrolled in a randomized, comparative setting study conducted at 10-15 investigational sites. Sixty subjects will be randomized to undergo treatment in an office setting, and 40 subjects will be randomized to undergo treatment in a hospital or ambulatory surgical center (ASC) setting. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids. Saline infused sonohysterogram images (SIS) obtained at three months post treatment will be compared to pre-treatment images, to determine the percent reduction in target pathology volume. Additionally, subject self-reported pain scores (as rated on an 11 point scale) will compare pain occurring during the treatment procedure to the average pain level experienced during a PAP smear. Economic data will be collected and compared between the two treatment settings.

HOME Study: Hysteroscopic Office Myomectomy Evaluation

A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding (AUB)

The Journal of Minimally Invasive Gynecology

Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment

Percent volume reduction of target pathology between baseline and month three post treatment assessments, as measured by saline infused sonohysterogram.

Mean difference in pain score compared between subject-rated assessment of pain occurring during a pap smear and pain occurring during the MyoSure treatment procedure, based on the Wong-Baker Faces Rating Scale (FRS)

Hologic, Inc.

Myomectomy for uterine polyps and/or fibroids occurring in an office setting

Myomectomy: Removal of fibroids and / or polyps

Treatment, Office Setting, Myomectomy

Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting

Myomectomy: Removal of fibroids and / or polyps

Treatment, Hospital Setting, Myomectomy

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Christina Mastandrea / Clinical Research manager

A total of 108 pathologies were removed in 74 patients. Among the 108 pathologies removed, 53 were removed in the office setting (28 myomas, 25 polyps) and 55 were removed in the ASC setting (14 myomas, 41 polyps).

Percent Reduction in Target Pathology Volume

Percent of Subjects That Achieve 100% Removal of Target Pathology

Subject Self-reported Pain Score Occurring During the Treatment Procedure

Overall Study

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Anti-Arrhythmia Agents

Channel Blockers

Ibuprofen

Lidocaine

Subject will receive a cervical block of 1% lidocaine and 0.25% bupivacaine, with injections in the following locations: 2cc at 12:00, 10cc at 3:00, 10 cc at 9:00, 5 cc at 4:00, 5 cc at 8:00, and 5 cc at 6:00.

Subject will receive a cervical block of 1% lidocaine and 0.25% bupivacaine, with injections in the following locations: 10 cc at 4:00, and 10 cc at 8:00.

Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg every 8 hours, for the first 24 hours and then PRN.

Subjects will receive a post procedure pain management regimen of ibuprofen 800 mg PRN.

The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade.When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.

Hysteroscopic Morcellator

Andrea Lukes, MD

The purpose of this study is to develop a recommended local anesthetic protocol and post-treatment pain management regimen, in order to assure patient comfort during office-based treatment with the MyoSure Hysteroscopic Tissue Removal Device. Subject self-reported pain scores (as rated on an 11 point scale) will be compared at multiple time intervals between all treatment groups.

Forty subjects will be enrolled in a randomized, controlled study conducted at four physician offices or day surgery settings. Subjects will be randomized 1:1 to a local anesthetic group (Group #1 or Group #2). Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids. Subsequent to the procedure, subjects will be randomized 1:1 within the local anesthetic group to a post procedure pain management group (Group A or Group B). Subject self-reported pain scores (as rated on an 11 point scale)will be compared at three time points: Immediately post procedure, prior to discharge from the treatment facility, and at 48 hours post procedure.

Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

Interlace Medical Comparative Sedation Study

John Vozella, V.P Clinical & Regulatory Affairs

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Immune System Diseases

Hypertrophy

Cicatrix, Hypertrophic

Cicatrix

Psoriasis

Eczema

Keloid

Lichen Planus

Prurigo

Acne Vulgaris

Scleroderma, Localized

Neurodermatitis

Alopecia

Alopecia Areata

Granuloma

Granuloma Annulare

Epidermal Cyst

Keratoacanthoma

Muir-Torre Syndrome

Skin Diseases

Skin Diseases, Papulosquamous

Hypotrichosis

Hair Diseases

Dermatitis

Skin Diseases, Eczematous

Lichenoid Eruptions

Exanthema

Rheumatic Diseases

Collagen Diseases

Fibrosis

Lymphoproliferative Disorders

Lymphatic Diseases

Necrobiotic Disorders

Prurigo Nodularis

Lichen Planopilaris

Frontal Fibrosing Alopecia

Morphea

Localized Scleroderma

Sodium Channel Blockers

Diuretics, Potassium Sparing

This arm will include an injection mixture of corticosteroid and lidocaine

This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.

Corticosteroid with lidocaine

Corticosteroid with normal saline

Brian Drolet, MD

Corticosteroid therapy, including intralesional and topical applications, has many indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However, these injections can be quite painful, which leads many patients to discontinue treatment.

Often, the injection involves a mixture of local anesthetic and corticosteroids despite a lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine component of the injection can actually cause a significant burning sensation during the procedure. Lidocaine does not have anti-inflammatory properties and does not treat the underlying pathology. By including another medication, lidocaine also adds cost and risk to the procedure.

The purpose of this study is to see if removing lidocaine from intralesional injections decreases the pain of injection.

Pain Outcomes Following Intralesional Corticosteroid Injections

The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial

IPD will not be shared with other researchers

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.

Vanderbilt University Medical Center

Assistant Professor

This arm will include an injection mixture of corticosteroid and lidocaine

Corticosteroid with lidocaine: Intralesional corticosteroid injection

Corticosteroid With Lidocaine

This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.

Corticosteroid with normal saline: Intralesional corticosteroid injection

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
Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm	NCT03316066	Complex Regiona...	stellate gangli... stellate gangli...	18 Years - 80 Years	Maisonneuve-Rosemont Hospital
HOME Study: Hysteroscopic Office Myomectomy Evaluation	NCT01152112	Uterine Fibroid... Polyps	Myomectomy	18 Years - 55 Years	Hologic, Inc.
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
Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System	NCT00979342	Uterine Fibroid... Polyps	Hysteroscopic M...	18 Years - 65 Years	Hologic, Inc.
Pain Outcomes Following Intralesional Corticosteroid Injections	NCT03630198	Keloid Alopecia Areata Acne Hypertrophic Sc... Epidermal Inclu... Frontal Fibrosi... Lichen Plano-Pi... Keratoacanthoma Plaque Psoriasi... Lichen Simplex ... Prurigo Nodular... Nummular Eczema Granuloma Annul... Morphea Lichen Planus	Corticosteroid ... Corticosteroid ...	12 Years -	Vanderbilt University Medical Center

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