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临床试验/CTRI/2022/01/039249
CTRI/2022/01/039249尚未招募不适用

“COMPARISON OF EFFICACY OF ULTRASOUND-GUIDED ERECTOR SPINAE BLOCK VERSUS ULTRASOUND-GUIDED THORACOLUMBAR INTERFASCIAL PLANE BLOCK FOR PERIOPERATIVE ANALGESIA IN LUMBAR DISCECTOMY SURGERIESâ€

IMS BHU1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Visual analogue scale

研究概览

简要总结

The study will be conducted in Department of Anaesthesiology, IMS, BHU,Varanasi after obtaining written and informed consent and institutional ethical approval. After CTRI registration,60 patients undergoing lumbar disectomy surgeries, of age 25 to 50 years will be included. Patients will be excluded from study if patient has local infection or significant coagulopathy/bleeding disorders,allergy to Local anaesthetics,psychiatric disorders,history of previous spine surgery and patient refusal. Patient will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelop technique into two equal groups.

Group (E) will receive USG guided erector spinae block at the level of third lumbar vertebra with 20ml of 0.2% ropivacaine with dexmeditomedine 1mcg/kg on either side.

Group (T) will receive USG guided thoracolumbar interfascial plane block at the level of third lumbar vertebra with 20 ml 0.2% ropivacaine with dexmeditomedine 1mcg/kg on either side.

After 20 minutes,block effect will be checked and those patients for whom block is unsuccessful ,will be excluded from the study.

Then patient will be placed in supine position and anesthesia is induced with propofol 2 mg/kg titrated to effect plus fentanyl 2 μg/kg will be administered for analgesia and muscle relaxation will be achieved with vecuronium 0.1 mg/kg following which oral endotracheal intubation will be done. Anesthesia will be maintained with isoflurane 1MAC and nitrous oxide in 30% oxygen.Inj.Fentanyl 1mcg/kg will be repeated every hourly intraoperatively.

For rescue analgesia in postoperative period,Injection ketorolac 30mg will be given.

In intraoperative period,hemodynamic parameters  (Heart rate,systolic/diastolic/mean blood pressure) will be monitored at minutes 3,5,15,30,60,then hourly,total fentanyl consumption intraoperatively and duration of surgery are noted.

In postoperative period,VAS score will be monitored at 30 minutes,hours 1,6,13,24 (at rest and in motion),time for requirement of first rescue analgesia,total rescue analgesia needed in 24 hours,l and time of mobilisation of patient are noted.

The study will end after mobilisation of patient,after all data has been collected.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
25.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • ASA grade 1,2 Cases of prolapsed intervertebral disc(PIVD) undergoing disectomy.

排除标准

  • Patient’s age <25 years and >50 years.
  • Patients with Bleeding diasthesis.
  • Patient allergic to LA agents.
  • Presence of infection at the injection area.
  • Patients with H/O previous spine surgeries.
  • Refusal of consent.

结局指标

主要结局

Visual analogue scale

时间窗: 30 minutes,hours 1,6,12,24

次要结局

  • Total rescue analgesia requirement in 24 hours(24 hours)

研究者

发起方
IMS BHU
申办方类型
Government medical college

研究点 (1)

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