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临床试验/NCT02766556
NCT02766556已完成不适用

The Effect of Dexamedetomidine for Interscalene Brachial Plexus Block on Plasma Cortisol and IL-6 After Rotator Cuff Repair: a Prospective Randomized Study

Chuncheon Sacred Heart Hospital0 个研究点目标入组 50 人开始时间: 2014年8月最近更新:
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
50
主要终点
change of five biomarkers (IL-6 in pg/ml, cortisol in ng/ml, IL-8 in pg/ml, IL-1beta in pg/ml, substance p in pg/ml) level due to pain after shoulder surgery.

研究概览

简要总结

The present study was designed to test the hypothesis that dexmedetomidine added to ropivacaine for interscalene brachial plexus blocks for elective shoulder surgery would enhance the duration and effect of analgesia when compared with ropivacaine alone, and their influence on serum IL-6, cortisol, IL-1beta, IL-8, and substance p.

详细描述

Background The incidence of severe postoperative pain after shoulder surgery is 30% to 70%.The postoperative pain should be relieved for early rehabilitation and recovery. Patient-controlled analgesia (PCA) with opiate therapy may control some of the postoperative pain, but it has several side effects such as nausea, vomiting, and dizziness, which can prevent early discharge. Conversely, there are several regional blocks to control postoperative pain. Interscalene brachial plexus block (ISB) is known as one of the most effective regional blocks for shoulder surgery, but it has relatively short duration of effect.

Dexmedetomidine (DEX), a selective agonist of α2-adrenergic receptors, can be an effective adjuvant to local anesthetics for peripheral nerve block. Preclinical and clinical studies have described prolonged duration of analgesia when dexmedetomidine was added to bupivacaine, levobupivacaine, or ropivacaine for peripheral perineural blocks.

Pro-inflammatory cytokines, such as interleukin-6 (IL-6), shows a high association with acute pain because they sensitize the nervous system. IL-6 levels in the plasma are detectable 60 minutes after injury, peaking at 4-6 hours, and are proportional to tissue injury.

Increased plasma cortisol concentrations can be detected within 15 minutes following exposure to a stressor. And several biomarkers related to pain have been studying.

Method 50 patients with rotator cuff tears who had undergone arthroscopic rotator cuff repairs were enrolled in this study. Rotator cuff tears were diagnosed by preoperative magnetic resonance imaging, and the size of the rotator cuff was confirmed at the time of arthroscopic operation. Indication for surgery was a symptomatic full-thickness rotator cuff tear or a partial thickness rotator cuff tear of more than 50% thickness in case of failed conservative therapy. Twenty-five patients were randomly allocated to group 1 and received both ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine . The other 25 patients were allocated to group 2 and received ISB with 8mL of ropivacaine with 1ml of normal saline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • a definite rotator cuff tear that needed repair seen on preoperative magnetic resonance imaging
  • acceptance of arthroscopic surgery including rotator cuff repair
  • age more than 20 years,
  • acceptance of preemptive regional block , PCA and blood sampling after 1 ,6, 12, 24, 48 hour postoperatively. .

排除标准

  • they did not undergo arthroscopic rotator cuff repair
  • they stopped PCA before 48 hours postoperatively because of associated side effects
  • there was a history of a previous shoulder operation or fracture
  • there was a concomitant neurologic disorder around the shoulder
  • refusal of blood sampling.

研究组 & 干预措施

arm 1

Active Comparator

received ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine

干预措施: dexmedetomidine (Drug)

arm 1

Active Comparator

received ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine

干预措施: ISB (Procedure)

arm 1

Active Comparator

received ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine

干预措施: Ropivacaine (Drug)

arm 2

Placebo Comparator

received ISB with 8mL of ropivacaine with 1ml of normal saline

干预措施: ISB (Procedure)

arm 2

Placebo Comparator

received ISB with 8mL of ropivacaine with 1ml of normal saline

干预措施: Ropivacaine (Drug)

结局指标

主要结局

change of five biomarkers (IL-6 in pg/ml, cortisol in ng/ml, IL-8 in pg/ml, IL-1beta in pg/ml, substance p in pg/ml) level due to pain after shoulder surgery.

时间窗: change from preoperation(baseline) IL-6, cortisol, IL-8, IL-1beta, and substance p level 1, 6, 12, 24, 48 hours after surgery due to postoperative pain

次要结局

未报告次要终点

研究者

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

Jae Jun Lee

associate professor

Chuncheon Sacred Heart Hospital

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