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临床试验/NCT04783194
NCT04783194已完成不适用

Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries, a Randomized Clinical Trial.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3月15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
50
试验地点
1
主要终点
First time to analgesic requirement

研究概览

简要总结

The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • physical status American Society of Anesthesiologists (ASA) I or II.

排除标准

  • refuse to participate have a body mass index (BMI) >30 kg/m2 ASA physical status >II have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) coagulation abnormalities infection at the injection site tumor in the paravertebral space sepsis Severe chest deformity or scoliosis, due to the possibility of injection into the meninges an allergy or contraindications to the drugs used in the study uncontrolled diabetes patients with active gastric ulceration a history of drug addiction or alcohol abuse a psychiatric illness mental retardation interfering with the evaluation of pain scores.

研究组 & 干预措施

Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery

Active Comparator

Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia

干预措施: Dexamethasone+ Bupivacaine (Drug)

Bupivacaine in bilateral TiPVB in lumbar spine surgery

Active Comparator

Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia

干预措施: Bupivacaine (Drug)

结局指标

主要结局

First time to analgesic requirement

时间窗: 1st 24 hour

After extubation, an IV PCA system will be connected to the patient (Accufuser Plus® 100 mL: Woo Young Medical Co, Korea). PCA will be prepared with 60 mL of normal saline containing 60 mg of morphine, and the system will be programmed to give a 0.5 mL bolus dose with a lockout interval of 8 min. basal rate will not be present. PCA will be discontinued at 24 h after surgery, and at that time, oral analgesics begin.

次要结局

  • Total opioid consumption .(1st 24 hour)
  • Visual analogue scale (VAS)(1st 24 hours postoperatively)

研究者

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

Amin Mohammed Alansary Amin Ahmed Helwa

Assistant professor

Ain Shams University

研究点 (1)

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