跳至主要内容
临床试验/NCT04974762
NCT04974762已完成不适用

Comparing Truncal Blocks Versus Wound Infiltration for Subcutaneous Implantable Cardioverter Defibrillator Implantation

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年1月23日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Nima Shariat

Assistant Professor, Anesthesiology, Perioperative & Pain Medicine

Icahn School of Medicine at Mount Sinai

研究点 (1)

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