The Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling for Stress Urinary Incontinence: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
Liposomal bupivacaine or placebo will be administered at the end of a transobturator midurethral sling to determine if there is a difference in a patient's perceived postoperative pain.
详细描述
The investigators aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain from placement of transobturator slings for the treatment of stress urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adults > 18 years of age
- •Planning for outpatient surgical treatment of SUI with placement of a transobturator suburethral sling under general anesthesia
排除标准
- •Pregnant or nursing
- •Allergy to bupivacaine
- •History of drug/alcohol abuse
- •Severe cardiovascular, hepatic, renal disease, or neurological impairment°
- •Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
- •Contraindication to:
- •acetaminophen
- •oxycodone
- •non-steroidal anti-inflammatory drugs (NSAID)
- •Administration of an investigational drug within 30 days before study
- •Chronic pain syndromes
- •Daily NSAID/opioid use
- •Patients having concomitant procedures or not undergoing general anesthesia
- •Patients who require a concomitant anterior repair or urethrocele repair will not be excluded as this requires the same dissection in the anterior vaginal wall.
研究组 & 干预措施
Liposomal bupivacaine
Subjects in this arm will received the drug - liposomal bupivacaine 30 ml.
干预措施: Liposomal bupivacaine (Drug)
Placebo
Subjects in this arm will received the placebo - normal saline 30 mL.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: 4 hours after being discharged home
To determine if liposomal bupivacaine administered at the completion of a transobturator suburethral sling will result in decreased postoperative pain compared to placebo.
次要结局
- Likert scale to rate their level of satisfaction with their postoperative pain control.(At 1 and 2 weeks postoperatively)