跳至主要内容
临床试验/NCT03480984
NCT03480984已完成不适用

A Comparison Between Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery: A Randomized Controlled Trial

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
50
试验地点
1
主要终点
Opioid consumption 24 hours postoperatively

研究概览

简要总结

The researchers are trying to determine pain medication consumption in the first 24 hours after surgery in patients given the standard continuous infusion of local anesthetic versus patients given the same total dose via programmed intermittent dosing. Both groups will receive the option of patient controlled pain medication as well as the same dose of pre-programmed pain medication. The only difference is the rate of administration: continuous vs. hourly intervals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

Investigators will not have direct access to settings on the pump

入排标准

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

入选标准

  • •Documentation of planned thoracic surgery for which a paravertebral catheter is indicated based on surgeon request as well as appropriateness of location of surgical site.
  • •Ability for subject to comply with the requirements of the study.

排除标准

  • •Pregnancy.
  • •Coagulopathy at time of evaluation or surgery.
  • •Infection at the site of needle insertion.
  • •Allergy to local anesthetic.
  • •Patient refusal.
  • •Chronic opioid use

研究组 & 干预措施

Programmed Intermittent Bolus

Active Comparator

6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus

干预措施: Programmed Intermittent Bolus (Other)

Continuous Infusion

Active Comparator

6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion

干预措施: Continuous Infusion (Other)

结局指标

主要结局

Opioid consumption 24 hours postoperatively

时间窗: first 24 hours postoperatively

morphine equivalents of opioids in mg will be obtained from medical record

次要结局

  • Opioid consumption 48 hours postoperatively(first 48 hours postoperatively)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elird Bojaxhi, M.D.

Principal Investigator

Mayo Clinic

研究点 (1)

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