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临床试验/NCT03449329
NCT03449329已完成不适用

Randomised Controlled Double Blinded Trial Analyzing Impact of Serratus Intercostal Plane Block in Video Assisted Thoracic Surgery on Postoperative Pain and Recovery.

AZ Sint-Jan AV2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年4月1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
21
试验地点
2
主要终点
Opioid consumption during the first 24 hours postoperative

研究概览

简要总结

Rationale Video Assisted Thoracic Surgery (VATS) is known to be a moderate painful procedure. There are many ways to manage postoperative pain following this kind of surgery. One of the 'golden standards' nowadays is epidural analgesia using Patient Controlled Epidural Analgesia (PCEA). Patient Controlled Intravenous Analgesia (PCIA) is also an option, as are several kinds of regional anesthesia. One of the most recent described regional blocks is the Serratus Anterior Plane block (SAP), also called Serratus Intercostal Plane (SIP) block.

Objectives The objective of this study is to evaluate the efficacy and opioid sparing effect of a SIP block in postoperative pain relief after VATS.

Hypotheses Patients receiving a SIP block prior to surgery need less opioids during and 24h after VATS compared with patients who didn't receive a SIP block.

Study design Single center randomized controlled trial Study population Patients older than 18 years old scheduled for VATS. Main study parameters/endpoints The primary endpoint is the opioid use during the first 24 hours after start of surgery. Secondary endpoints are the VAS score on day 0 and day 1 after surgery, and the prevalence of postoperative nausea and vomiting (PONV).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness In the intra-operative period, patients will not experience discomfort from either strategy because of general anesthesia. If the hypothesis proves to be true, patients with SIP block could benefit from a lower amount of received opioids, which could give less chance of opioid associated adverse effects. There won't be any additional blood sampling related to this study.

详细描述

The proposed randomized controlled trial aims at comparing the opioid use per- and postoperatively in patients with versus without SIP block undergoing VATS.

We hypothesize that use of a SIP block results in less opioid use during and the first 24 hours after VATS as compared with patients without SIP block.

Single center randomized controlled trial on patients undergoing VATS under general anesthesia.

We intend to recruit patients scheduled for elective VATS in our hospital during a period of 3 months. Surgical patients will be screened twice a week, because there are two days a week that VATS procedures take place in our hospital. We will randomize 20 patients, based on the power analysis (cfr infra).

Inclusion criteria: Patients scheduled for VATS under general anesthesia Exclusion criteria

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 scheduled for thoracoscopic surgery

排除标准

  • urgent surgery
  • allergic to Sufentanil or Ropivacaine

结局指标

主要结局

Opioid consumption during the first 24 hours postoperative

时间窗: first 24 hours postoperative (after wound closure)

total dose of opioids given

次要结局

  • Intraoperative opioid consumption(intra operative (from incision till wound closure))

研究者

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

Jan Mulier

Head of department of anesthesiology,

AZ Sint-Jan AV

研究点 (2)

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