Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal | OTHER_GOV |
Not provided
Not provided
Not provided
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:
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracervical block | Active Comparator | 10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total). |
|
| Transcervical block | Experimental | 10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Injection | Drug | evaluation of pain by using two different types of local anesthesia |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janey Fang, MD | Contact | 5142513051 | jfang85@uwo.ca | |
| Chantal Rivard, MD | Contact | 5142513051 | rivardch@videotron.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mélissa Roy, MD | OB-GYN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIUSSS de l'Est de l'Île de Montréal | Montreal East | Quebec | H1T 2M4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15559340 | Background | Readman E, Maher PJ. Pain relief and outpatient hysteroscopy: a literature review. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):315-9. doi: 10.1016/s1074-3804(05)60042-4. | |
| 10826574 | Background | Lau WC, Tam WH, Lo WK, Yuen PM. A randomised double-blind placebo-controlled trial of transcervical intrauterine local anaesthesia in outpatient hysteroscopy. BJOG. 2000 May;107(5):610-3. doi: 10.1111/j.1471-0528.2000.tb13301.x. |
Not provided
Not provided
There is not a plan to make IPD available
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D047708 | Myofibroma |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Multicentric, prospective, randomized trial, single-blinded, where eligible patients will be randomized to either receive paracervical or transcervical anesthesia before outpatient surgical hysteroscopy
Not provided
Not provided
Not provided
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 |
| 31982584 | Background | De Silva PM, Mahmud A, Smith PP, Clark TJ. Analgesia for Office Hysteroscopy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1034-1047. doi: 10.1016/j.jmig.2020.01.008. Epub 2020 Jan 23. |
| 9050737 | Background | Bettocchi S, Selvaggi L. A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc. 1997 Feb;4(2):255-8. doi: 10.1016/s1074-3804(97)80019-9. |
| 9091008 | Background | Cicinelli E, Didonna T, Ambrosi G, Schonauer LM, Fiore G, Matteo MG. Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: a randomised placebo-controlled double-blind study. Br J Obstet Gynaecol. 1997 Mar;104(3):316-9. doi: 10.1111/j.1471-0528.1997.tb11460.x. |
| 10426243 | Background | Lau WC, Lo WK, Tam WH, Yuen PM. Paracervical anaesthesia in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial. Br J Obstet Gynaecol. 1999 Apr;106(4):356-9. doi: 10.1111/j.1471-0528.1999.tb08274.x. |
| 7843454 | Background | Zupi E, Luciano AA, Valli E, Marconi D, Maneschi F, Romanini C. The use of topical anesthesia in diagnostic hysteroscopy and endometrial biopsy. Fertil Steril. 1995 Feb;63(2):414-6. |
| 1420022 | Background | Broadbent JA, Hill NC, Molnar BG, Rolfe KJ, Magos AL. Randomized placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy. Br J Obstet Gynaecol. 1992 Sep;99(9):777-9. doi: 10.1111/j.1471-0528.1992.tb13886.x. No abstract available. |
| 20332307 | Background | Cooper NA, Khan KS, Clark TJ. Local anaesthesia for pain control during outpatient hysteroscopy: systematic review and meta-analysis. BMJ. 2010 Mar 23;340:c1130. doi: 10.1136/bmj.c1130. |
| 22969951 | Background | Kosus N, Kosus A, Guler A, Simavli SA, Turhan NO. Transcervical intrauterine levobupivacaine infusion or paracervical block for pain control during endometrial biopsy. Exp Ther Med. 2012 Apr;3(4):683-688. doi: 10.3892/etm.2012.463. Epub 2012 Jan 30. |
| 12660281 | Background | Guida M, Pellicano M, Zullo F, Acunzo G, Lavitola G, Palomba S, Nappi C. Outpatient operative hysteroscopy with bipolar electrode: a prospective multicentre randomized study between local anaesthesia and conscious sedation. Hum Reprod. 2003 Apr;18(4):840-3. doi: 10.1093/humrep/deg075. |
| 22588748 | Background | Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available. |
| 3785962 | Background | Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9. |
| 20027030 | Background | Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace. |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |