Comparing Truncal Blocks Versus Wound Infiltration for Subcutaneous Implantable Cardioverter Defibrillator Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Intraoperative and postoperative opioid consumption
研究概览
简要总结
This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay.
详细描述
This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay. The procedures involved for the study are the placement of the described truncal blocks or wound infiltration. Data to be collected are patient demographics, history of present illness, past medical history, and pain management techniques required (i.e non-narcotics and narcotics use). In addition, age, race, gender and BMI will also be collected. Intraoperative analgesia requirements, postoperative analgesia requirements, duration of procedure and length of stay will also be collected.
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
- None
盲法说明
The researcher assessing the subjects postoperatively will be different from the anesthesiologist that performs the interventions.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Patients undergoing S-ICD placement
排除标准
- •Allergy to amide local anesthetics
结局指标
主要结局
Intraoperative and postoperative opioid consumption
时间窗: Up to Post-Op Day 10
Total intraoperative and postoperative opioid consumption of subjects
次要结局
- Non-opioid analgesic consumption(Up to Post-Op Day 10)
- Sedation (propofol) requirements intraoperatively(Day 1, Day of Surgery)
- Number of participants with ICU stay(Up to Post-Op Day 10)
- Duration of ICU stay(Up to Post-Op Day 10)
- Visual Analog Pain score(Up to Post-Op Day 10)
- Total procedure time(Day 1 at Surgery)
- Length of stay(Day 1 at Surgery)
研究者
Ali Nima Shariat
Assistant Professor, Anesthesiology, Perioperative & Pain Medicine
Icahn School of Medicine at Mount Sinai
