Programmed Intermittent Bolus for Infusion of Local Anesthetic During Continuous Interscalene Nerve Blockade for Total Shoulder Arthroplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Pain score on 11 point (0 - 10) numeric rating scale
研究概览
简要总结
A new infusion strategy named the 'programmed intermittent bolus' (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion that delivers such dose over an hour. The PIB technique has demonstrated superior patient satisfaction and reduced local anesthetic consumption when utilized for pain control during labour and delivery. However, it is not known if the PIB technique gives any benefits during a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT) is to elucidate if PIB is better than (traditional) continuous infusion for postoperative analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with respect to pain control.
详细描述
Local anesthetics are often given in a continuous fashion to block specific nerves after an operation for pain control. A new infusion strategy named the 'programmed intermittent bolus' (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion that delivers such dose over an hour. The PIB technique has demonstrated superior patient satisfaction and reduced local anesthetic consumption when utilized for pain control during labour and delivery. However, it is not known if the PIB technique gives any benefits during a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT) is to elucidate if PIB is better than (traditional) continuous infusion for postoperative analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with respect to pain control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •American Society of Anesthesiologists (ASA) Physical Status I to III
排除标准
- •Body mass index (BMI) > 40
- •Not able to communicate in ENglish
- •Unable to obtain consent
- •Infection over site of placement
- •Severe respiratory disease
- •Cognitive or psychiatric history that would make it difficult to assess pain score
- •Complex regional pain syndrome
- •Chronic pain condition such as fibromyalgia, neuropathic pain
- •Preoperative opioid use greater than the equivalent of morphine 50 mg PO daily
- •Allergy to any of the study drug
- •Coagulopathy
结局指标
主要结局
Pain score on 11 point (0 - 10) numeric rating scale
时间窗: FIrst 24 hour since the operation
Postoperative pain score
次要结局
- Side effect(through to patient discharge, on average 48 hours)
- Local anesthetic consumption(36 hours (or until block discontinuation))
- Block complication(through to patient discharge, on average 48 hours)
- Opioid consumption(48 hours (or until discharge))
- patient satisfaction(through to patient discharge, on average 48 hours)
研究者
Shalini Dhir
Associate Professor
Lawson Health Research Institute