跳至主要内容
临床试验/NCT03931343
NCT03931343Unknown不适用

Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery

Bezmialem Vakif University0 个研究点目标入组 60 人开始时间: 2020年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Total morphine consumption

研究概览

简要总结

Spinal surgery is typically associated with severe postoperative pain. Although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. The recently described thoracolumbar interfacial plane block (TLIPB) has been reported to provide effective postoperative analgesia in spinal surgery. In addition, the recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the spina muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. In this study, the investigators aimed to compare the analgesic efficacy of TLIPB and ESPB in spinal 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
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

  • 20-75 years
  • Patients scheduled for elective surgery

排除标准

  • Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
  • Allergy to drugs
  • Major cardiac disease
  • Renal failure
  • Psychiatric disease
  • Patients who refuse to participate in the study
  • Chronic back and lower back pain

结局指标

主要结局

Total morphine consumption

时间窗: 48 hour

The total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.

次要结局

  • Pain intensity score at rest(48 hour)
  • Pain intensity score at movement(48 hour)
  • Time to first rescue analgesia(48 hour)
  • Postoperative nausea and vomiting(48 hour)
  • Patient satisfaction score(48 hour)

研究者

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

Serdar Yeşiltaş

İnstructor

Bezmialem Vakif University

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