The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection
研究概览
简要总结
This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.
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)
盲法说明
Patients will be blinded to which arm they are in, surgeon will not as they will be performing injection however will not be assessing pain scores
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
- •Women over the age of 18 years old
- •undergoing benign minimally invasive hysterectomy with minimally invasive GYN surgeon at Johns Hopkins Hospital
- •Patients must be English speaking.
排除标准
- •Pregnancy
- •allergy, contraindication, or intolerance to bupivacaine, opioids, Tylenol, or NSAID drugs
- •pre-operative daily opioid consumption
- •peri-operative transverse abdominis plane block
- •recent history of drug or alcohol abuse (in last year)
- •severe cardiovascular, hepatic or renal disease.
研究组 & 干预措施
No injection
No injection will be performed
干预措施: Bupivacaine (Drug)
Normal Saline Injection
Normal saline will be injected into the uterosacral ligaments prior to colpotomy
干预措施: Bupivacaine (Drug)
Bupivacaine Injection
Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection
时间窗: 7 days post-op
Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference
次要结局
- Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection(7 days post-op)
- Time to first bowel movement following uterosacral ligament bupivicaine injection(7 days post-op)