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临床试验/NCT04062045
NCT04062045Unknown不适用

Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After Video-assisted Thoracic Surgery Procedures

Surgery Bitenc1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年10月14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
发起方
入组人数
50
试验地点
1
主要终点
Usage of opioid analgetics

研究概览

简要总结

Investigators will analyze the efficacy of continuous regional anesthesia through a catheter under erector spinae muscle in a prospective, randomized, double blind, placebo-controlled study. Investigators will include 50 adults, predicted for elective lung surgery with video-assisted thoracic surgery (VATS) technique. Patients will be randomly assigned to group A or B.

Investigators will insert a catheter under the erector spinae muscle (ESC) at the T4 level of the operated side under ultrasound guidance. All patients will receive an initial bolus of 20ml levobupivacaine 0,5% through the catheter. Group A will receive a continuous infusion 5ml/h of ropivacaine 0,2% and intermittent boluses of the same local anesthetic 15ml/4h through the ESC. Group B will receive a continuous infusion of 0,9% saline in the same doses. All patients will have a PCA pump with piritramide 1mg/ml to cover the pain. All patients will receive regular doses of paracetamol and metamizole as part of multimodal analgesia.

Investigators will compare pain, assessed with the VAS scale in resting and coughing and piritramide usage in both groups. Investigators will compare the incentive spirometry results at 24 and 48 hours postoperatively and observe for possible late complications.

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, Care Provider, Investigator)

盲法说明

Masking the infusion mixture by using the same shape of the drug/placebo bottle and wrapping it into non-transparent sheath.

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

  • Signed written informed consent
  • ASA I-III
  • Elective video-assisted thoracic surgery with 3 ports technique
  • No contraindications for regional anesthesia

排除标准

  • Allergy to local anesthetic
  • Pregnancy, breastfeeding
  • Inflammation in the area of ES catheter insertion
  • Inability to use the PCA pump

研究组 & 干预措施

Group A - Local anesthetic group

Experimental

Group A will receive a continuous infusion of ropivacaine 0,2% 5ml/h and intermittent boluses of the same local anesthetic 15ml/4h through the erector spinae catheter.

干预措施: Ropivacaine Hcl 0.2% Inj Vil 10Ml (Drug)

Group B - Placebo group

Placebo Comparator

Group B will receive a continuous infusion of 0,9% saline 5ml/h and intermittent boluses of the same fluid 15ml/4h through the erector spinae catheter.

干预措施: Saline 0.9% (Drug)

结局指标

主要结局

Usage of opioid analgetics

时间窗: Continually 48 hours post surgery

Investigators will measure the total consumption of i.v. piritramide after surgery.

次要结局

  • Subjective pain score(Every hour in the 48 hours post surgery)
  • Incentive spirometry(24 and 48 hours after surgery)
  • Satisfaction with analgesia(1 day (at dismissal from hospital.))

研究者

发起方
Surgery Bitenc
申办方类型
Other
责任方
Sponsor

研究点 (1)

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