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临床试验/NCT04714112
NCT04714112已完成4 期

Comparison of the Effects of Different Time of Intravenous Dexamethasone on Brachial Plexus Block: a Randomized Control Study

Shanghai Jiao Tong University Affiliated Sixth People's Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Duration of sensory block

研究概览

简要总结

Dexamethasone has been tested as an effective adjuvant to prolong the effect of local anesthetics for peripheral nerve blocks, both perineurally and intravenously. The purpose of this study is to investigate the effect of the addition of dexamethasone (5mg) at different time to a standard ropivacaine solution (0.5%) on analgesic duration of interscalene block.

详细描述

Interscalene brachial plexus block (ISB) is regarded as the standard of care for anesthesia and analgesia for shoulder surgery by providing the superior analgesia and reducing opioid consumption. After several hours when the effects of single injection ISB wear off, the patients often suffer moderate to severe pain of the surgical insult and required strong opioid analgesia. Efforts to prolong ISB duration by adding adjuvants to local anesthetic (eg. clonidine, dexmedetomidine) have been studied with promising results. Dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect ~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. Intravenous administration of dexamethasone was reported to have similar effects as perineural route indicating the possible mechanism for prolonging analgesic duration might be due to the systemic effects of dexamethasone. We hypothesized: should that is the reason, systemic administration of dexamethasone at different time may provide similar effects on the duration of peripheral nerve block. Dexamethasone is a slow effect cortisone with long half-time, it is widely used at the beginning of surgery to prevent postoperative nausea and vomiting. A trial that demonstrates enhanced block quality and duration associated with intravenous dexamethasone at different time may allow us to achieve prolonged duration of effect if dexamethasone is used in perioperative period for different purpose. This would further identify the possible mechanism of dexamethasone to prolong the analgesia effect of local anesthetics.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing arthroscopic shoulder surgery at Shanghai Sixth People's Hospital.
  • ASA functional status class I to II
  • Age 18 to 70 years
  • BMI ≤ 35 kg/m2

排除标准

  • Lack of patient consent
  • Allergy to dexamethasone or ropivacaine
  • BMI > 35 kg/m2
  • Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
  • Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
  • Pregnant or nursing females
  • Chronic opioid use defined as > 30mg oral morphine or equivalent per day

研究组 & 干预措施

preoperative group

Experimental

Intravenous dexamethasone (5mg) is used when ultrasound guided ISB is performed.

干预措施: dexamethasone (Drug)

postoperative group

Active Comparator

Ultasound guided ISB is performed before operation and intravenous dexamethasone (5mg) is used in postoperative care unit ( PACU)

干预措施: dexamethasone (Drug)

结局指标

主要结局

Duration of sensory block

时间窗: one day postoperative

from completion of ISB to VAS for pain \> 0 ( in hours)

次要结局

  • Visual Analog Scale for pain ( from 0 to 10 )(7 days postoperative)
  • Time to First Opioid Consumption(one day postoperative)
  • Opioid Consumption(two days postoperative)
  • Postoperative Serum Blood Glucose(one day postoperative)
  • Infection(7 days postoperative)
  • Number of Participants With Postoperative Nausea and/or Vomiting(7 days postoperative)
  • Number of Participants With Nerve Damage From Interscalene Block(7 days postoperative)

研究者

发起方
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Quanhong Zhou

Principal Investigator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

研究点 (1)

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