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临床试验/NCT01842698
NCT01842698终止2 期

Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy

Centre Jean Perrin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年4月1日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
发起方
入组人数
60
试验地点
2
主要终点
The overall failure rate of the para-vertebral block

研究概览

简要总结

Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain. Control of the pain is essential in the perioperative management.

Nowadays, there are several strategies to support this pain, including regional anesthesia techniques in the context of multimodal analgesia. Epidural analgesia reduces pain scores and respiratory complications significantly. ParaVertebral Block (PVB) is a technique as effective as epidural analgesia in the treatment of pain after thoracotomy and could present a more limited number of complications. However, there is no consensus on the best technique for realisation of PVB.

Para-vertebral catheterisation can be performed by posterior approach in seeking a strength loss after bone contact of transverse vertebral process using the technique of Eason and Wyatt, but it is a blind technique. The ultrasonographic control, developed in the context of all puncture invasive actions, is an effective contribution to the realisation of a BPV, but still insufficiently validated. First used to measure the distance skin - posterior costo-transverse ligament and skin - parietal pleura before procedure, the ultrasonography has recently led to the publication of echo-guided techniques combining recognition of structures defining the space para- vertebral, viewing the progression of the needle and the spread of the local anesthetic. The handling of the ultrasonographic probe associated with the puncture requires additional learning.

The objective of this project is to study the feasibility of para-vertebral catheter insertion under ultrasonographic control. The appearance like "pigtail" of the catheter, the most recently proposed, seems the more attractive in terms of safety. The aim of this pilot prospective study is accurately quantify all qualitative parameters related to the technique in order to achieve a future validation with a medico-economic component.

Ultrasound-guided technique will correspond to a technique with a puncture of the lateral to medial space described by Shibata, after spotting of the first rib proposed by Bouzinac.

This study will be proposed to patients undergoing thoracotomy for total or partial pulmonary resection in Thoracic Surgery service of Centre Jean Perrin, the number of patients required is 60 patients over a period of inclusion of 12 months.

详细描述

Prospective followed of cohort including consecutive patients, all receiving the same technique of anesthesia and analgesia:

  • Preoperative para-vertebral catheterisation on the surgery side.
  • Preoperative test of the efficiency of para-vertebral block.
  • Conventional general anesthesia.
  • Conventional rescue postoperative analgesia.
  • Systematic radiographic control with injection of contrast product into the para-vertebral catheter.
  • Conventional postoperative monitoring.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing programmed lateral or posterolateral thoracotomy, regardless of indication,
  • Aged 18 to 80 years

排除标准

  • Surgery performed in the emergency;
  • Specific clinical contexts including neoplasia in terminal phase or palliative phase;
  • Contraindications to the products of the study

结局指标

主要结局

The overall failure rate of the para-vertebral block

时间窗: 24 hours

The overall failure rate of the para-vertebral block ( failed installation or efficiency)

次要结局

  • Paravertebral block efficiency(24 hours)
  • Pain evaluation(H0+30 min, +1h, +1h30, +2h, +4h, +8h, +12h, +16h, +20h, +24h, +32h, +40h, +48h)
  • Tolerance hemodynamic, nausea and vomiting(72 hours)
  • The time (in minutes) between the start of the installation and the effective para-vertebral block obtaining(24 hours)
  • Paravertebral block catheterisation(24 hours)

研究者

发起方
Centre Jean Perrin
申办方类型
Other
责任方
Sponsor

研究点 (2)

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