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临床试验/NCT03572686
NCT03572686Unknown不适用

Comparison of the Effects of Adding Dexamethasone at 0.25% Ropivacaine With 0.5% Ropivacaine Alone in the Supraclavicular Brachial Plexus Block

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年4月13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
入组人数
90
试验地点
2
主要终点
analgesic effects (the intensity of pain)

研究概览

简要总结

The supraclavicular brachial plexus block is widely used in upper limb surgery below the shoulder. However, this can easily lead to long-term motor nerve blockage, Horner's syndrome, phrenic nerve paralysis or systemic poisoning, and even serious side effects such as cardiac arrest.

Dexamethasone is a synthetic corticosteroid and becoming more common to use steroids as an adjunct to local anesthetics in brachial plexus block.

In order to reduce the incidence of long-acting topical anesthetics from the nerve block in the supraclavicular arm, reducing the local anesthetic concentration is a feasible method, but this will also result in a shorter time to neurological block. The investigators hypothesized that the addition of Dexamethasone 5 mg to low concentrations (0.25%) of Ropivacaine would prolong postoperative analgesia.Therefore, the purpose of this study was to compare the postoperative analgesia and the side effects of postoperative supraclavicular brachial plexus blockade with the addition of Dexamethasone 5mg to Ropivacaine (0.5%) alone and Ropivacaine (0.25%) in low concentrations.

详细描述

The supraclavicular brachial plexus block is widely used in upper limb surgery below the shoulder. Although it is easier and more stable than axillary nerve block and subclavian brachial plexus block, long-acting local anesthetics are used for long-term blockade with traditional block methods. However, this can easily lead to long-term motor nerve blockage, Horner's syndrome, phrenic nerve paralysis or systemic poisoning, and even serious side effects such as cardiac arrest.

Ropivacaine is a novel long-acting topical amine amine topical anesthetics that lasts long and has anesthetic and analgesic effects. Its pharmacological characteristics are low cardiotoxicity, sensory block and motor block separation at low concentrations more obvious, and with the external peripheral vasoconstriction. Therefore, the drug is especially suitable for postoperative analgesia. Dexamethasone is a synthetic corticosteroid for the treatment of a wide range of symptoms including rheumatic diseases, certain skin diseases, severe allergies, asthma, chronic obstructive pulmonary disease, cerebral edema, and may also be combined with antibiotics for tuberculosis patients. It is becoming more common to use steroids as an adjunct to local anesthetics in brachial plexus block. Steroids have neurological blockade effects by blocking the nociceptive transmission of pith-type C-fibers and inhibiting the release of ectopic neurons. Dexamethasone, as a local anesthetic adjuvant in peripheral nerve block, has also been widely studied recently.

In order to reduce the incidence of long-acting topical anesthetics from the nerve block in the supraclavicular arm, reducing the local anesthetic concentration is a feasible method, but this will also result in a shorter time to neurological block. The investigators hypothesized that the addition of Dexamethasone 5 mg to low concentrations (0.25%) of Ropivacaine would prolong postoperative analgesia. Therefore, the purpose of this study was to compare the postoperative analgesia and the side effects of postoperative supraclavicular brachial plexus blockade with the addition of Dexamethasone 5mg to Ropivacaine (0.5%) alone and Ropivacaine (0.25%) in low concentrations.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American society of Anesthesiology classification: I ~ III
  • patients who have undergone arm surgery for blockage of the upper clavicle from nerve block

排除标准

  • Patients had brachial plexus degeneration, coagulation abnormalities, obvious heart, lung, liver or kidney disease, body mass index less than 18.5 or greater than 35, body weight greater than 80 kg, pregnancy, regular use of steroids or opiates Opioids, chronic medication or alcohol abuse, as well as previous allergies or adverse reactions to opiates, dexamethasone, or the use of topical anesthetic Ropivacaine, were excluded from this study.

研究组 & 干预措施

Group Ropivacaine High (RH)

Sham Comparator

Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml + N/S 1.6mL.

干预措施: Ropivacaine 0.5% 20mL (Drug)

Group Ropivacaine Low (RL)

Placebo Comparator

Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.25% 20ml + N/S 1.6mL.

干预措施: Ropivacaine 0.25% 20ml (Drug)

Group Ropivacaine Low + Dexamethasone (RLD)

Experimental

Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.25% 20ml + Dexamethasone 8mg (1.6mL).

干预措施: Ropivacaine 0.25% 20ml + dexamethasone 8mg (Drug)

结局指标

主要结局

analgesic effects (the intensity of pain)

时间窗: 24 hours after the end of surgery

The intensity of pain was assessed using a 0 to 10 Numerical Rating Scale (NRS) to quantify their degree of pain; where 0 means no pain and 10 conceivably the worst pain.

次要结局

  • blood pressure(1 hour after the end of surgery)
  • heart rate(1 hour after the end of surgery)
  • motor block(24 hours after the end of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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