A Randomized Controlled Trial (RCT) Comparing Presacral Nerve Block Versus Sham Block on Post-operative Pain in Women Undergoing Total Laparoscopic Hysterectomy.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Early post-operative pain at 3 hours following surgery
研究概览
简要总结
The study is a single-center parallel group randomized controlled trial comparing the administration of a presacral nerve block using 20mL of local ropivacaine 5.0mg/ml versus 20mL of normal saline (sham block) on post-operative pain following total laparoscopic hysterectomy.
详细描述
The proposed study is a single-center parallel-group RCT comparing the administration of a presacral nerve block using 20mL of local ropivacaine (5.0mg/ml) versus 20mL of normal saline (sham block). This drug/dose was selected based on the recent study by Rapp et al., which instilled 20mL of ropivacaine into the presacral nerve at the time of open hysterectomy.
Participants will be selected using a convenience sample from Mount Sinai Hospital's outpatient gynecology clinics. All patients age 18 years and older undergoing total laparoscopic hysterectomy will be considered for inclusion. Exclusion criteria include: previous presacral neurectomy, concurrent surgical procedure other than salpingectomy and/or oophorectomy, gynecological cancer beyond stage 1 disease, chronic opioid consumption, fibromyalgia, BMI > 50, language barriers, inability to communicate, or inability to provide consent. All potentially eligible patients will be invited to participate in this study by their surgeon. Interested patients will then meet with a member of the research team to explain the study and obtain informed consent.
The investigators will create a randomization list using a computer-generated allocation sequence in equal ratio (1:1) to either study group with study numbers 1 to 60. A clinic nurse, unaffiliated with any other aspects of the study, who works 5 days per week in the ambulatory office and who will have no other role in this study, will prepare and label the active and placebo syringes according to the randomization list. Each syringe will be prepared individually and provided to the surgeon on the day of surgery.
Study participants will be randomized on the day of surgery. The surgeon will instill the contents from the labeled syringe (either drug/placebo) into the presacral space as the first step prior to starting the hysterectomy.
The surgeon, research team, participants, and data analysts will be blinded to treatment group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The surgeon, research team, participants and data analysts will be blinded to treatment group. Our clinic nurse, who works 5 days per week in our ambulatory office and who will have no other role in this study, will prepare the active and placebo syringes and label the syringes according to the randomization list. Each syringe will be prepared individually and provided to the surgeon on the day of surgery. Study participants will be randomized on the day of surgery. The surgeon will instill the drug/placebo from the labeled syringe into the presacral space as the first step prior to starting the hysterectomy.
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
- •18 years of age or older
- •Undergoing total laparoscopic hysterectomy
排除标准
- •Previous presacral neurectomy
- •Concurrent surgical procedure other than salpingectomy and/or oophorectomy
- •Gynecological cancer beyond stage 1 disease
- •BMI > 50
- •Chronic opioid consumption
- •Fibromyalgia
- •Language barrier
- •Inability to communicate and provide consent
研究组 & 干预措施
Sham Block
20mL of normal saline (sham block) instilled in the presacral space
干预措施: Normal saline injection (Drug)
Presacral Nerve Block
Presacral nerve block using 20mL of local ropivacaine 5.0mg/ml instilled in the presacral space
干预措施: Ropivacaine injection (Drug)
结局指标
主要结局
Early post-operative pain at 3 hours following surgery
时间窗: 3 hours following surgery
Early post-operative pain measured at 3-hours following surgery by a self-administered numeric pain rating scale (NRS) on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable
次要结局
- Post-operative pain at other time points(1 hour, 2 hour, and post-operative days 1, 2 and 7)