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临床试验/CTRI/2021/04/032741
CTRI/2021/04/032741已完成不适用

Efficacy of ultrasound guided erector spinae plane block for post-operative pain relief in hip joint and proximal femur surgeries- A randomised controlled study

Hetal Kotecha1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年4月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
Duration of Analgesia and

研究概览

简要总结

  • Aim of the study is to know efficacy of ultrasound guided erector spinae plane block for post-operative pain relief in hip joint and proximal femur surgeries.
  • Patients suitable for study as per inclusion criteria, admitted in SSG Hospital will be selected.
  • Demographic details, History, Investigations will be assessed and general examination, systemic examination will be done
  • Patients will be randomly divided into two groups after surgery being done under spinal anaesthesia. 3 ml of Hyperbaric bupivacaine 0.5% will be given in spinal anaesthesia.
  • Case group will be given ultrasound guided lumbar erector spinae plane block 4-6 cm lateral to spinous process and superficial to transverse process of L4 vertebra in the erector spinae plane. Total 30 cc local anaesthetic drug- 0.25% Bupivacaine will be injected using convex ultrasound transducer probe using out plane approach.
  • Control group will be given injection tramadol 1.5 mg/kg intravenously in 100 ml Normal saline as infusion.
  • Patients will be monitored for duration of analgesia using VAS score, Rescue analgesics required in 24 hours, Vital parameters and complications associated with block.
  • VAS (Visual Analogue Scale) score will be assessed every 1 hourly for first 6 hours and every 6 hourly for next 24 hours.
  • Rescue analgesia will be given in the form of Injection Paracetamol 15 mg/kg intravenously at VAS score>4.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •ASA grading- I,II,III Patient posted for hip joint and proximal femur surgeries Patient able to give verbal and informed consent Patient able to understand VAS regarding assessment of Pain.

排除标准

  • •Patient not willing Allergy to local anesthetics Contraindication of spinal, regional anaesthesia Patient with coagulopathy, local infection Patient with pre-existing neurological deficits Patient with history of drug or alcohol abuse, psychiatric illness Patient with pelvic fracture.

结局指标

主要结局

Duration of Analgesia and

时间窗: Pain will be assessed using VAS (Visual Analogue Scale) score every 1 hour for first 6 hours and every 6 hours for next 24 hours | Rescue analgesia will be given in the form of Injection Paracetamol 15 mg/kg iv at VAS score more than 4

No of Rescue analgesic requirement within 24 hours

时间窗: Pain will be assessed using VAS (Visual Analogue Scale) score every 1 hour for first 6 hours and every 6 hours for next 24 hours | Rescue analgesia will be given in the form of Injection Paracetamol 15 mg/kg iv at VAS score more than 4

次要结局

  • Vital parameters and(Complications associated with block)

研究者

发起方
Hetal Kotecha
申办方类型
Other [self]

研究点 (1)

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