Does Liposomal Bupivacaine Improve Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse? A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively
研究概览
简要总结
To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.
详细描述
In the last 20 years, laparoscopic surgery has assumed an important role in gynecological surgery. Unfortunately, patient surveys indicate there has been little improvement in the incidence and severity of postsurgical pain in the past two decades. Postoperative pain is a common complaint, occurring in 5-15% of patients and has been shown to significantly contribute to overall patient dissatisfaction. It can lead to increased consumption of opioids, with subsequent nausea, delayed bowel function, and prolonged postoperative recovery. In an attempt to address pain related complications with port-site wounds, various methods of pain control have been attempted. Currently, no standard of care exists and management is based on surgeon and anesthesiologist preferences.
This study seeks to determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.
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
- Double (Participant, 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
- 否
入选标准
- •Adults 18 years of age or older
- •Planning for surgical treatment of POP with robotic sacrocolpopexy and rectocele repair under general anesthesia
- •Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included
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 use 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 not undergoing general anesthesia
- •Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or fistula repair
研究组 & 干预措施
Bupivacaine Arm
Those subjects in the liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).
干预措施: Bupivacaine (Drug)
Placebo Arm
Those subjects in the placebo arm will have 30 mL sterile normal saline injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected into the port site wounds in the abdomen (5 sites, 4 mL per incision).
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively
时间窗: 18 hours after surgery
VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.
次要结局
未报告次要终点