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临床试验/NCT05092490
NCT05092490已完成不适用

Serratus Anterior Plane Block Combined With Transversus Thoracic Muscle Plane Block Versus Conventional Local Anesthetic Infiltration for SICD Implantation: A Randomized Controlled Trial

New York Presbyterian Brooklyn Methodist Hospital2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Postoperative pain score measured

研究概览

简要总结

This is a prospective randomized study. The aim is to investigate the efficacy of a combined SAPB with TTPB for perioperative pain control compared to the standard local anesthetic infiltration technique in adult patients undergoing SICD implantation. The hypothesis is that the combined plane block provides better pain control compared to the standard local infiltration technique.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants are not informed about which block they are receiving

1 study personnel assess the pain scores and patient satisfaction postoperative

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

  • Patient is able to provide a written informed consent.
  • Patient is scheduled to have an elective SICD implantation procedure.
  • Patient has none of the

排除标准

  • Exclusion Criteria:
  • Patient is unable to provide a written informed consent.
  • Patient is younger than 18 years old.
  • Patients with prior thoracotomy or other thoracic surgery altering anatomy.
  • Patients with neurological deficits.
  • Patients with impaired coagulation (Platelet count < 50,000 cells/mcl and/or INR > 1.4).
  • Patient on anticoagulation therapy.
  • Patient's weight below 50 kg

结局指标

主要结局

Postoperative pain score measured

时间窗: 1 day

by Numerical Rating Scale pain (0-10), 0 is no pain, 10 is the worst

次要结局

  • Patient satisfaction(1 day)
  • Intraoperative pain score measured(Intraoperative)
  • Intraoperative sedation score(Intraoperative)
  • Total local anesthetic volume used(Intraoperative)
  • Procedure duration(Intraoperative)
  • Intraoperative hemodynamics(Intraoperative)
  • Time to 1st rescue pain medication(1 day)
  • Block related complications(1 day)
  • Postoperative opioid consumption(1 day)

研究者

发起方
New York Presbyterian Brooklyn Methodist Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joel Yarmush

Program Director, Department of Anesthesiology, Principal Investigator, Clinical Professor

New York Presbyterian Brooklyn Methodist Hospital

研究点 (2)

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