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临床试验/NCT02744352
NCT02744352终止不适用

Comparison Between Single Shot Versus Continuous Infraclavicular Brachial Plexus Block for Postoperative Analgesia After Distal Radius Fracture: A Prospective Randomized Open Label Study

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Participants Need for Pain Relief as Measured by Opiate Consumption

研究概览

简要总结

The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to continuous catheter nerve block done in adult patients who have under gone surgery to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.

详细描述

If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:

  1. Single shot block
  2. Continuous catheter

In the institution investigators usually advocate for regional anesthesia and intravenous sedation for the repair of open fracture of the distal radius.

Patients will be monitored during block performance with standard ASA monitors. All patients will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.

Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite S nerve machine will be used with a low frequency curvilinear (C5) US probe with 2-5 MHZ frequency. Both single shot and continuous ICB will be performed according to the SOP in the department. Ultrasound survey of the deltopectoral groove below the clavicle will take place. The axillary artery and the three cords (posterior, medial and lateral) of the brachial plexus will be identified in short axis view deeper to the pectoralis minor muscle.

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
None

入排标准

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

入选标准

  • Patients scheduled for open reduction and internal fixation of a distal radius fracture
  • American Society of Anesthesiologists (ASA) physical status I -III
  • Mentally competent and able to give consent for enrollment in the study

排除标准

  • Patient younger than 18 years old
  • Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone and any of the drugs included in the standard of care
  • Patients opting to go under general anesthesia and those refusing the block
  • Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 6 months prior to the surgery
  • BMI of 40 or more

研究组 & 干预措施

continuous IBP block

Active Comparator

Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain

干预措施: 20ml bolus of 0.5% ropivicaine (Drug)

continuous IBP block

Active Comparator

Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain

干预措施: 0.2% of ropivacaine at 8 milliliter/hour (Drug)

single shot IBP block

Active Comparator

Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain

干预措施: 20ml bolus of 0.5% ropivicaine (Drug)

结局指标

主要结局

Participants Need for Pain Relief as Measured by Opiate Consumption

时间窗: 72 hours

Amount of opiate consumption

Pain Scores as Measured by the Visual Analog Scale

时间窗: 72 hours

Pain scores at rest and with movement.

次要结局

  • Quality of Recovery Score(72 hours)
  • Range of Motion as Measured by the Disability Assessment of Shoulder and Hand Questionnaire(3 months)
  • Number of Subjects With Insomnia as Measured by Sleep Questionnaire(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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