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临床试验/NCT04457557
NCT04457557招募中不适用

Evaluation of the Effect of Local Anesthetic Concentration on Rebound Pain After Interscalene Block for Shoulder Surgery

Ajou University School of Medicine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Rebound pain score

研究概览

简要总结

The rebound pain after nerve block could interfere with patient's recovery and rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.

详细描述

Shoulder surgery is related to more than moderate pain after surgery. Interscalene nerve block could reduce the postoperative pain effectively. When the effect of nerve block ends, however, rebound pain could appear. The rebound pain could interfere with patient's recovery and rehabilitation.

The mechanism of rebound pain is not well known. One of possible mechanism is that the pain stimulus that was blocked suddenly comes out, and it is perceived as more severe pain. The strength of the block may vary depending on the concentration of the local anesthetic. Therefore, the concentration of local anesthetics could affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.

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, Outcomes Assessor)

盲法说明

Only investigator who prepared the local anesthetics knows the group. Nerve block performer and outcome assessor are applied masking.

入排标准

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

入选标准

  • Elective shoulder surgery under general anesthesia and interscalene block for postoperative pain

排除标准

  • Contraindication of interscalene block: pulmonary disease, lung resection history, brachial nerve injury
  • Diabetic neuropathy
  • Adverse drug reaction history to ropivacaine, fentanyl
  • Impaired coagulation

结局指标

主要结局

Rebound pain score

时间窗: 48 hours after surgery

It is calculated by subtracting the visual analogue scale (VAS) of pain at the last time when the nerve block was effective from the highest VAS for 12 hours from the time when the nerve block effect disappeared. VAS of pain: 0=no pain \~ 10=very severe pain

次要结局

  • fentanyl bolus injection time(48 hours after surgery)
  • total postoperative fentanyl dose(48 hours after surgery)
  • Subjective satisfaction(48 hours after surgery)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

In-kyong Yi

Assistant professor

Ajou University School of Medicine

研究点 (2)

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