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临床试验/NCT02630498
NCT02630498终止不适用

The Role of Single Shot Brachial Plexus Block in Preventing Chronic Post Surgical Pain After Upper Limb Trauma Surgery

Lawson Health Research Institute4 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
55
试验地点
4
主要终点
Chronic Post Surgical Pain

研究概览

简要总结

This is a non-randomized prospective study. Patients undergoing upper extremity and shoulder surgical procedures after trauma at SJHC and LHSC will be divided in to two groups. The first group will include those who receive a single shot brachial plexus (interscalene, supraclavicular, infraclavicular and axillary) block with or without general anesthesia. The second group will be the control group and include those patients who receive general anesthesia only, without any block whether due to the preference of patient or the surgeon

详细描述

This is a non-randomized prospective study. Patients undergoing upper extremity and shoulder surgical procedures after trauma at SJHC and LHSC will be divided in to two groups. The first group will include those who receive a single shot brachial plexus (interscalene, supraclavicular, infraclavicular and axillary) block with or without general anesthesia. The second group will be the control group and include those patients who receive general anesthesia only, without any block whether due to the preference of patient or the surgeon. Patients will not be randomized for this study because regional anesthesia is proven to reduce acute postoperative pain and reduce the need for opioids. However, investigators will involve all patients who meet the inclusion criteria and give consent to participate in this study within the period of study between September 1st 2015 and February 28th 2017 (18 months). The block is usually performed with ultrasound guidance by the block Room team at both sites (consultant, fellow and resident). Block success will be checked and documented. Ropivacaine is the standard local anesthetic used in the block room at LHSC (University Hospital) and SJHC. However, the type of local anesthetics and the total volume are difficult to be standardized for all patients in this study, so it will be neglected during analysis. The block room at SJHC and LHSC perform around 100 blocks per month. Thirty percent of these blocks are for upper limb procedures. The same number of patients undergoes these procedures with no blocks at both SJHC and LHSC. Investigators expect to involve around 100 patients in each arm during the study period. All patients will be followed up for 6 months through filling a questionnaire and Brief Pain Inventory (BPI), which assess pain score and pain interference scale. The follow up will be through mail and /or phone call. Sample Size There is no previous study data provided the prevalence of CPSP in similar surgical procedure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Trauma patient undergoing orthopedic surgery for upper extremity or shoulder
  • Age >18 and < 75 years
  • Both males and females
  • Understand English (reading, writing and speaking)
  • Patient gives a written consent for being involved in this study

排除标准

  • Patient with any sort of chronic pain including fibromyalgia
  • Patient using opioids for >90 days
  • Patient who had an associated injury related to the trauma apart from that limb
  • Patient who need more than one surgery to fix the problem
  • Patient diagnosed with major depression
  • Failed or partially effective block
  • Bilateral surgical intervention

结局指标

主要结局

Chronic Post Surgical Pain

时间窗: Upto six months

次要结局

未报告次要终点

研究者

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

Shalini Dhir

AssociateProfessor

Lawson Health Research Institute

研究点 (4)

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