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临床试验/NCT04222010
NCT04222010已完成3 期

Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2020年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
155
试验地点
1
主要终点
Pain Visual analog scale (VAS) score at coughing

研究概览

简要总结

Acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. Firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery.

To date, several procedures have been described but the best modality of locoregional analgesia for thoracoscopic surgery has not been assessed yet. The main objective of this study is to evaluate efficiency of several validated approaches for preoperative locoregional analgesia, comparing serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery.

To this end, the investigators will conduct an interventional prospective monocentric, double blind, compared and randomized study. Previously to thoracoscopic surgery, patients will be randomized in one of the three following arms: serratus plain block, paravertebral block or serratus plain block and paravertebral block combined.

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
None

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

  • adult patient over18 years old
  • without guardianship
  • video-assisted thoracoscopic surgery with 3 trocars
  • No cons-indications to loco-regional anesthesia (allergy, skin condition)

排除标准

  • patient under 18 years old
  • patient under guardianship
  • rejection of consent
  • rejection of loco-regional anesthesia
  • chronic pain antecedents under morphine medication
  • pain assessment impossible

研究组 & 干预措施

serratus loco-regional anesthesia

Experimental

patient who underwent thoracoscopic surgery will be assigned to serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)

干预措施: loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL) (Drug)

结局指标

主要结局

Pain Visual analog scale (VAS) score at coughing

时间窗: Immediately after following thoracoscopic surgery

Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain. Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale. With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable).

次要结局

  • Pain Visual analog scale (VAS) score at coughing(Day3 = 3 days following thoracoscopic surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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