A Prospective Randomized Study Comparing Different Types of Local Anesthesia in Outpatient Procedural Hysteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •18 years of age or older
- •Indication of outpatient surgical hysteroscopy for polypectomy and myomectomy
排除标准
- •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
研究组 & 干预措施
Paracervical block
10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).
干预措施: Bupivacaine Injection (Drug)
Transcervical block
10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter
干预措施: Bupivacaine Injection (Drug)
结局指标
主要结局
To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy
时间窗: 15 minutes post 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
次要结局
- Compare the pain experience based on the visual analogue scale 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(15 minutes post hysteroscopy)
- To evaluate the need for an extra intravenous sedative dose.(during hysteroscopy)