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临床试验/NCT02963857
NCT02963857已完成不适用

Evaluation of a Breast Biblock Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery

Maison de Santé Prostestante de Bordeaux Bagatelle0 个研究点目标入组 9 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9
主要终点
The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.

研究概览

简要总结

This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery.

详细描述

Breast surgery is one of the most painful post-operative surgery. This surgery is well known to induce postoperative chronic pain. The paravertebral block, because of its efficacy and less invasive nature than epidural analgesia, is quickly becoming the reference technique for pain management of major breast surgery.

Peripheral regional anesthesia for the breast surgery appeared in the past few years. Among these techniques are the PEC block, Serratus block and more recently the pecto-intercostal fascial plane block (PIF block).

Currently in the investigators hospital in every day's practice, an association of the serratus block and the PIF block is made, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for analgesia of the lateral part of the breast.

This technique was previously described. The authors evoked the possibility of the association of serratus and PIF blocks and described this technique with a patient, but to the investigators knowledge no evaluation of the efficacy of this procedure was made.

The objective of the study is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association of blocks before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • total mastectomy surgery with a complete axillary lymph nodes removal

排除标准

  • age under 18
  • contraindication to the surgery
  • refusal of the protocol by the patient

结局指标

主要结局

The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.

时间窗: 3 days

次要结局

  • Pain levels on a numeric pain rating scale were recorded at rest and with arm mobilization during the first 72 hours.(3 days)
  • level of comfort during the first 72 hours was recorded (the 4 levels-scale used was: excellent, good, medium and bad).(3 days)

研究者

发起方
Maison de Santé Prostestante de Bordeaux Bagatelle
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Claude-Charles Balick-Weber

Claude-Charles Balick-Weber, MD

Maison de Santé Prostestante de Bordeaux Bagatelle

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