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临床试验/NCT04767256
NCT04767256已完成不适用

Intravenous Dexamethasone and Dexmedetomidine on the Analgesic Efficacy of Erector Spinae Plane Block for Posterior Lumbar Interbody Fusion Surgery

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年3月1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
状态
已完成
入组人数
120
试验地点
1
主要终点
The time to first rescue analgesic request

研究概览

简要总结

Patients having lumbar spinal fusion often complain about severe postoperative pain and postoperative rehabilitation process can be affected negatively. Postoperative pain that cannot be well controlled may lead to delayed mobilization, pulmonary and thromboembolic complications, prolonged hospital stays, and chronic pain syndromes. Pain after spinal surgery can arise from several different tissues, such as the vertebrae, disks, ligaments, dura, facet joint, muscle, fascia, and subcutaneous and cutaneous tissues.

Ultrasound-guided lumbar erector spinae plane block (ESPB) has been shown to reduce postoperative pain in patients undergoing posterior lumbar interbody fusion (PLIF). However, the duration of analgesia after single-shot ESPB with commonly used local anesthetics is reported to be no more than 12 h, which often not long enough to provide satisfactory postoperative pain relief, as the pain typically lasts for several days. Compared with perineural route, intravenous additives to local anesthetics are commonly accepted as its safety and efficiency have been reported. Moreover, co-administration of intravenous dexamethasone and dexmedetomidine significantly prolonged the time to first rescue analgesic request after single-shot interscalene brachial plexus block. However, more data are needed especially for lumbar ESPB.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 yrs
  • American Society of Anesthesiologists physical statusⅠ-Ⅲ
  • Involvement of ≤3 spinal levels
  • Undergo elective posterior lumbar interbody fusion
  • Informed consent

排除标准

  • A known allergy to the drugs being used
  • Pre-existing neuropsychiatric disorders or language barrier
  • Analgesics intake, history of substance abuse
  • Contraindications to peripheral nerve block
  • Acute cerebrovascular disease
  • Severe liver failure
  • Uncontrolled low blood pressure
  • Sinus bradycardia or atrioventricular block

研究组 & 干预措施

DD group

Experimental

co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg

干预措施: Dexamethasone and dexmedetomidine (Drug)

DD group

Experimental

co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg

干预措施: Ultrasound-guided lumbar erector spinae plane block (Other)

DD group

Experimental

co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg

干预措施: PCIA (Other)

D group

Placebo Comparator

intravenous dexmedetomidine 1 ug/kg

干预措施: Dexmedetomidine (Drug)

D group

Placebo Comparator

intravenous dexmedetomidine 1 ug/kg

干预措施: Ultrasound-guided lumbar erector spinae plane block (Other)

D group

Placebo Comparator

intravenous dexmedetomidine 1 ug/kg

干预措施: PCIA (Other)

结局指标

主要结局

The time to first rescue analgesic request

时间窗: Up to 48 postoperative hrs

The cumulative opioid consumption

时间窗: At 24 postoperative hours

次要结局

  • Postoperative hospital length of stay(Up to 3 weeks)
  • Adverse events(Up to 48 postoperative hrs)
  • The pain scores determined by the numeric rating scale (NRS, 0-10)(At 6, 12, 18, 24, 30, 36, 42, and 48 hrs after the surgery)
  • Incidence of postoperative nausea and vomiting(Up to 24 postoperative hrs)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xi Wu

Principal Investigator, Department of Anesthesiology, Union Hospital of Tongji Medical College

Huazhong University of Science and Technology

研究点 (1)

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