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临床试验/NCT02871193
NCT02871193已完成不适用

Study of Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy

The First Affiliated Hospital of Anhui Medical University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2016年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy

研究概览

简要总结

The procedures of thoracotomy are among the most painful operations. In addition to post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient and prevent postoperative complications such as pneumonia, atelectasis, or respiratory failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard technique for providing analgesia after a thoracotomy. However, TEA carries side-effects such as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an alternative technique for TEA that may offer a comparable analgesic effect and a better side -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as single injection, they can provide analgesia for limited period. Various adjuvants have been tried in the past in order to enhance the duration and quality of postoperative analgesia. Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of local anesthetic block. The mechanism of its action is blocking the nociceptive impulse transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have been shown to provide superior analgesia and greater patient satisfaction compared with intermittent administration. System of wire-less PCA provides remote monitoring, information management and PCA devices with high precision. The purpose of this research is to determine whether dexamethasone might prolong the duration of analgesia and improve the short-time outcomes when administered for TPVB along with local anesthetic agents in elective thoracotomy.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • patient American Society of Anesthesiologists(ASA) I~III undergoing elective thoracotomy
  • written informed consent from the patient or the relatives of the participating patient

排除标准

  • mental illness
  • thoracic paravertebral blocks contraindicated
  • local anesthetic allergy
  • people who have heart disease
  • people who have severe liver or renal disease
  • people who have severe endocrine disease
  • people who can't communicate effectively because of hearing or visual disorders

研究组 & 干预措施

Group C(Control)

Sham Comparator

Group C received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml combined with general anesthesia and intravenous patient controlled analgesia pump.

干预措施: saline (Other)

Group R(Ropivacaine)

Experimental

Group R received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20 ml combined with general anesthesia and intravenous patient controlled analgesia pump.

干预措施: Ropivacaine (Drug)

Group D(Dexamethasone)

Experimental

Group D received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg combined with general anesthesia and intravenous patient controlled analgesia pump.

干预措施: Ropivacaine (Drug)

Group D(Dexamethasone)

Experimental

Group D received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg combined with general anesthesia and intravenous patient controlled analgesia pump.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy

时间窗: 6 hours,12hours,24hours and 72hours after operation

to show the grading of pain in different groups after surgery

the reality pressing number of patient controlled analgesia(PCA) of patients with different treatment-related events in the following 3 days after surgery

时间窗: 6hours,12hours,24hours and 72hours after operation

to show the consumption of analgesics after surgery

次要结局

  • The first day of leaving bed after surgery(30 days after surgery)
  • The time of recovery(24 hours after surgery)
  • The time of extubation(24 hours after surgery)
  • the incidence of side effects(3days after operation)
  • hemodynamic index(24 hours after anesthesia)
  • The complication after surgery(30 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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