Randomized Control Trial for an Opioid Free Analgesic Pathway Post Cesarean Delivery
试验速览
- 阶段
- 2 期
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Total number of opioid free Cesarean deliveries
研究概览
简要总结
This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.
详细描述
The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All scheduled Cesarean deliveries with intrathecal or epidural anesthesia
排除标准
- •Emergency Cesarean deliveries
- •Multifetal gestation
- •Subjects <18 years old
- •Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners)
- •Cesarean delivery with general anesthesia
- •Known allergy or hypersensitivity to any of the study medications
- •Subjects that can't comprehend the visual analog scale for quantitative pain assessment
研究组 & 干预措施
Placebo
Wound infiltration with a placebo
干预措施: Placebo (Drug)
Bupivacaine
Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL
干预措施: Bupivacaine (Drug)
Bupivacaine and Dexmedetomidine
Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution .
干预措施: Bupivacaine (Drug)
Bupivacaine and Dexmedetomidine
Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution .
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Total number of opioid free Cesarean deliveries
时间窗: 1 year
Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course
次要结局
- Complications from procedures(0-14 days)
- Side effects/Adverse reactions(0-14 days)
- Breast feeding capacity(0-14 days)
- Time to first rescue analgesia(0 hour post-cesarean to time rescue analgeisa is administered])
- Total opioid consumption(0-14 days)
- Postoperative hospital stay(0-14days)
研究者
Nisha Lakhi, MD
Research Director
Richmond University Medical Center