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临床试验/NCT03669328
NCT03669328已完成不适用

Evaluation of Pain and Postoperative Nausea Vomiting Incidence in Outpatient Surgery at IUCT-Oncopole Hospital

Institut Claudius Regaud1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年6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
200
试验地点
1
主要终点
Evaluation of pain after surgery by Simple Verbal Evaluation

研究概览

简要总结

The effectiveness of the analgesic and anti-nausea prevention techniques of the investigators justifies being evaluated regularly in order to adapt the management strategy to the specificities of each surgical act.

A first evaluation took place in June 2016 and allowed to identify a category of patients (partial breast surgery with or without axillary gesture) not benefiting from an ideal algological management because justifying in 30% of the cases of a level 3 analgesic remedy in the postoperative recovery room. This use of morphine results in a significant incidence of postoperative nausea and prolonged recovery time before return home harmful to the patient.

With their experience in locoregional anesthesia technique in complete breast surgery (total mastectomy) and aware of the effectiveness of this type of anesthesia on the management of immediate and chronic pain, the investigators have extended their indications of ALR to partial breast surgery in ambulatory.

详细描述

During the anesthesia consultation, the risk of postoperative nausea and vomiting (PONV) is evaluated by the Apfel score (Apfel CC, Anesthesiology 1999) and a preventive strategy correlated to this score is then determined. An order including anti-emetics and analgesics is given to the patient for the return home after the outpatient surgery.

On the day of the outpatient surgery, patients receive in the operating room the prevention of PONV according to their level of risk (according to the recommendations of the Société Française d'Anesthésie et de Réanimation - SFAR 2008 and Guidelines 2014) and analgesics including a level II and NSAIDs (in the absence of contraindication).

All patients underwent general anaesthesia with sufentanil and propofol. Mechanical ventilation was performed with laryngeal mask. A echoguided regional anesthesia was performed by injection of 20 ml of ropivacaine 3.75 mg/ml above and under the serratus muscle as described by Blanco and al (ref 3)" In the postoperative recovery room, PONV is treated if necessary by an anti-emetic class different from those used in the block. In postoperative pain with EVA> 3, morphine titration is performed as recommended.

Patients are then monitored in an outpatient surgery unit until they have a home-based return capability assessed by the CHUNG score, including the level of pain (moderate and well relieved), the absence of persistent nausea, and the ability to ambulation.

All outpatient surgery patients are called the day after their return home to ensure the absence of complications according to the regulatory procedure related to outpatient anesthesia.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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 admitted for ambulatory surgery under general anesthesia
  • patients admitted during the period from 01 to 30 June 2016 or during the period from 18 to 5 July 2018

排除标准

  • Patient neither French nor English,
  • Patient refusing to participate in this study
  • Minor patients were excluded to ensure the homogeneity of the surveyed population (satisfaction of minors not meeting the same characteristics as that of adults)

结局指标

主要结局

Evaluation of pain after surgery by Simple Verbal Evaluation

时间窗: 1 day (the day of the surgery)

Pain level in post-operative room measured by Simple Verbal Evaluation. The simple verbal scale or Keele scale has 5 qualifiers to describe the intensity of the pain, each descriptor is associated with a numerical value. 0 = no pain, 1 = poor, 2 = moderate, 3 = intense, 4 = atrocious. The goal of management is to achieve pain values below 3 (low to moderate).

次要结局

  • Evaluation of home-based return capability by CHUNG score(1 day (just after the surgery))
  • Incidence of postopérative nausea and vomiting after prevention strategy guided by Apfel score risk(1 day before surgery)
  • Evaluation of pain at home after surgery at mobility by EVA during the first 3 days(3 days (from surgery to 3 days after))
  • Evaluation of pain at home after surgery at rest by EVA during the first 3 days(3 days (from surgery to 3 days after))
  • Medical procedure characteristics(1 day (the day of the surgery))
  • Evaluation of pain after surgery by Opioid requirements(3 days (from surgery to 3 days after))
  • Evaluation of sleep quality(3 days (from surgery to 3 days after))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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