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临床试验/NCT04763434
NCT04763434Unknown4 期

Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study

Gansu Provincial Hospital0 个研究点目标入组 90 人开始时间: 2021年3月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
90
主要终点
the duration of analgesia

研究概览

简要总结

The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB.

详细描述

Design: A prospective, randomized, controlled study Setting: Single-center university hospital. Participants: The study included 90 patients undergoing lobectomy under general anesthesia.

Interventions: The patients were allocated randomly into the following 3 groups: 20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone (RS group) or 1 µg/kg dexmedetomidine (RM group), or with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group). Ultrasound-guided TPVB was performed at 4 points-T4-5, T5-6, T6-7, and T7-8 of the surgical side; 5 mL of solution were injected at each point. Postoperatively, the PCIA was used as part of multimodal analgesia, and all patients recieve .

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, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • ASA physical status I-II grade Undergoing elective lobectomy under general anesthesia. Participants aged from 16-65 years old.

排除标准

  • Refusal for TPVB Inability to obtain informed consent Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2 Pregnancy Infections at the site of injection for the TPVB Allergy to dexamethasone; dexmedetomidine; ropivacaine Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases

研究组 & 干预措施

RS group

Active Comparator

20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone

干预措施: dexamethasone; dexmedetomidine; ropivacaine (Drug)

RM group

Active Comparator

20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine

干预措施: dexamethasone; dexmedetomidine; ropivacaine (Drug)

RSM group

Experimental

20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group)

干预措施: dexamethasone; dexmedetomidine; ropivacaine (Drug)

结局指标

主要结局

the duration of analgesia

时间窗: 48 hours after surgery

time from completion of TPVB operation to VAS more than 3

次要结局

  • total sufentanil consumption(48 hours after surgery)
  • VAS(1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery)
  • adverse effects(48 hours after surgery)

研究者

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

dong zhang

dong zhang

Gansu Provincial Hospital

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