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临床试验/CTRI/2021/01/030405
CTRI/2021/01/030405已完成不适用

Efficacy of superficial cervical plexus block in the management of neck pain due to surgical positioning in patients undergoing burr hole craniotomy for unilateral chronic subdural haematoma under scalp block

NOT APPLICABLE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月13日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Neck pain (assessed by NRS scaling)

研究概览

简要总结

This study is designed to assess the effect of superficial cervical plexus block for managing neck pain in patients of unilateral chronic subdural hematoma to be operated under the scalp block. In a case series of Management of Refractory Neck Pain Secondary to Cervicothoracic Myofascial Pain Syndrome patients received TPI with 0.25% levobupivacaine and reported significant relief for 2 weeks. Thereafter, the patient underwent 3 courses of TPI with a mixture of levobupivacaine and depot steroids and reported relief of 30% lasting 4 weeks after each course. Furthermore, the patient underwent a unilateral iCPB  & reported 60% relief at 6-month review.

There is myofacial pain due to prolonged surgical positioning of patients during unilateral burr hole awake craniotomy after giving scalp block .So, we hypothesized that ultrasound guided preoperative superficial cervical plexus block will lead to decreased neck pain & relief the  muscle spasm that occurs  postoperatively in chronic SDH surgery. In the present study neck pain (assessed by NRS scaling) assessed as primary outcome and hemodynamic stability, muscle spasm (assessed by modified Ashworth scale),  dose of rescue analgesic required, patients satisfaction score as secondary outcome during post-op period.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • Posted for burr hole craniotomy for unilateral chronic subdural haematoma
  • Have negative radiographs of the shoulders and cervical spine.

排除标准

  • h/o of neck shoulder pain radiating to arm radiculopathy
  • Malignancy
  • Hypothyroidism
  • Complete blood count (CBC) with high creatine phosphokinase (CPK)
  • Autoimmune diseases that are associated with subclinical myopathy
  • Fibromyalgia
  • coagulopathy
  • Have allergy to bupivacaine
  • Patient refusal.

结局指标

主要结局

Neck pain (assessed by NRS scaling)

时间窗: 1,2,4,6,24 hours of post operative period

次要结局

  • Muscle spasm (assessed by modified Ashworth scale)(1,2,4,6,24 hours of post operative period)
  • consumption of analgesic(1,2,4,6,24 hours of post operative period)
  • patient comfort(1,2,4,6,24 hours of post operative period)

研究者

申办方类型
Other [NOT APPLICABLE ]

研究点 (1)

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