Does Spinal Anesthesia for Prolapse Surgery With Concomitant Sling Procedures Lead to an Increase in Urinary Retention Compared to General Anesthesia?
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Incidence of postoperative urinary retention
研究概览
简要总结
The purpose of the study is to compare the risk of being unable to urinate shortly after surgery, also called acute post-operative urinary retention (POUR) between spinal and general anesthesia in women who undergo outpatient pelvic organ prolapse with stress urinary incontinence surgery.
详细描述
A randomized trial to compare urinary retention rates between spinal and general anesthesia in women who undergo outpatient pelvic organ prolapse surgery with concomitant incontinence surgery.
Randomization
Randomization will be done in the pre-operative area, on the day of surgery. Computer generated randomization will be done in blocks of 4. Sealed numbered envelopes will be opened prior to surgery and the subject will then be assigned to spinal or general anesthesia. Patient randomization on day of surgery was discussed with anesthesia and it thought that randomizing on the same day would be safe.
Preoperatively
Subjects will be asked to complete a validated questionnaire, the Quality of Recovery 15 (QoR-15) prior to surgery, at their preoperative visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over the age of 40
- •Women scheduled for pelvic organ prolapse surgery as well as concomitant incontinence sling surgery
- •Post-void residual <150 cc prior to surgery
- •Surgery length of at least 1 hour
- •ASA class 1-2
排除标准
- •Contraindications to surgery
- •Contraindications to outpatient surgery, and requiring inpatient stay for medical comorbidities. The decision for a required inpatient stay will be decided prior to surgery based on the recommendations of the patient's primary care physician or specialist, such as cardiology or pulmonology.
- •ASA class 3 or 4 that would be a contraindiction to both spinal or general anesthesia
- •Evidence of voiding dysfunction or urinary retention on pre-operative urodynamics, including PVR >150, or dyssynergic sphincter dyssynergia
- •Neurological diseases that can interfere with spinal anesthesia
- •Anticoagulation therapy within a week of surgery
- •History of back surgery that would prevent successful spinal anesthesia
- •History of back deformity, such as scoliosis that would prevent successful spinal anesthesia
结局指标
主要结局
Incidence of postoperative urinary retention
时间窗: within the first week after surgery
bladder emptying completeness after surgery
次要结局
未报告次要终点
研究者
Laura Martin
Urogynecology Fellow in the Department of Gynecology
The Cleveland Clinic