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临床试验/NCT03721406
NCT03721406已完成不适用

The Pharmacokinetic of Ropivacaine in Patients Undergoing Ultrasound-guided Continuous Thoracic Paravertebral Block

Attikon Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年10月8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
发起方
入组人数
20
试验地点
2
主要终点
ropivacaine plasma levels

研究概览

简要总结

The study aims to investigate the pharmacokinetic of ropivacaine in patients undergoing ultrasound guided thoracic paravertebral block (TPVB) both after a single-bolus injection via the thoracic paravertebral catheter given before the start of surgery and after continuous thoracic paravertebral infusion that will start after the end of the procedure in order to achieve postoperative analgesia after open thoracotomy during the first 3 postoperative days

详细描述

Patients aged >18yrs, of ASA I-III undergoing open thoracotomy under combined ultrasound guided thoracic paravertebral block (TPVB) and general anesthesia will be enrolled in the study.

TPVB will be performed under ultrasound guidance on the side of the operation immediately after induction of anesthesia and patient intubation, with the patient in the lateral position at the T5 or T6 or T7 thoracic level using a Tuohy 17G needle and the catheter will be advanced 5 cm beyond the point of needle tip.

Dosage regimen Initially, after catheter placement and control, 0.5% ropivacaine is administered via the catheter in a 25 ml single dose, before the start of surgery.

After the end of surgery and patient awakening, the catheter will be connected with an electronic pump and the continuous infusion of ropivacaine 0.2% will start with a constant infusion rate of 14 ml/h for the first 3 postoperative days.

Postoperative pain will be assessed using the Visual Analogue Scale (VAS: 0-10). Postoperative analgesia will be managed with continuous PVB, and systemic administration of paracetamol (1 gr X 4 iv), tramadol (100 mg x 3 iv) and pregabalin (75 mg x 2 pos). Additionally, if VAS is ≥4-5 morphine (2.5 -5mg) will be administered subcutaneously as rescue analgesic drug (max 6 doses/day). In case of persistent pain (VAS > 4-5) despite the previously mentioned treatment measures, PCA morphine will be used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • Age >18 years
  • ASA I-III
  • Open thoracotomy

排除标准

  • Patient refusal
  • Age <18 years
  • Morbid obesity
  • Scoliosis
  • Previous thoracotomy
  • Drug allergy
  • Severe systemic disease
  • ASA > III
  • Hypoalbuminemia
  • Urgent surgery
  • Reoperation during the study period

研究组 & 干预措施

Ropivacaine

Other
  • 25 ml single dose of 0.5% ropivacaine
  • continuous infusion of ropivacaine 0.2% with a constant infusion rate of 14 ml/h

干预措施: Ropivacaine (Drug)

结局指标

主要结局

ropivacaine plasma levels

时间窗: up to 72 postoperative hours after the initiation of continuous thoracic paravertebral infusion of ropivacaine

Ropivacaine plasma levels in both arterial and venous blood samples collected at regular intervals

次要结局

  • Clinical signs of local anesthetic toxicity(Up to 72 hours after the initiation of continuous thoracic paravertebral infusion of ropivacaine)

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paraskevi Matsota

Assoc Prof of Anaesthesiology

Attikon Hospital

研究点 (2)

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