Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca (FIB) Block for Emergency Department Analgesia in Hip Fractures: A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID)
研究概览
简要总结
Pain management is a crucial aspect of the care of hip fracture patients. Patients with poorly controlled pain have an increased risk of delirium, long-term functional impairment, and remain hospitalized longer. Today, to relieve hip fracture pain, fascia iliaca block is routinely performed in the emergency department in addition to other pain medications administered by vein or by mouth. Several studies have questioned the analgesic efficacy of this block, suggesting the superiority of the newer PENG block. The purpose of this multicenter, randomized study is to compare the analgesic efficacy of PENG block versus fascia iliaca block, hypothesizing the superiority of the new approach over the gold standard. Participants will be blindly assigned in a 1:1 ratio to the study or control group, recruited from the Emergency Departments of IRCCS Policlinico San Matteo and Colchester Hospital (UK).
The main outcome is represented by the reduction of pain after the two blocks, measured as %SPID (percentage of "pain intensity difference"), a value derived from VAS scale measurements in the first hour post-procedure. Secondly, we will evaluate the proportion of patients with satisfactory pain control, the amount of opioids used and the safety profile of the two approaches.
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
- Double (Participant, Care Provider)
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
- •Capacity to understand the aim of the study, the potential benefits and side-effects of the procedures
- •Capacity to provide consent
- •Capacity to provide a self-assessment of pain using the written VAS Scale
- •Confirmed radiological diagnosis of hip fractures (including subcapitate, transcervical, intertrochanteric and perthrocanteric fractures)
- •Moderate or severe worst pain (visual analogue scale, VAS >40 mm) (at rest or dynamic)
排除标准
- •Known hypersensitivity to local anaesthetics
- •Confirmed radiological diagnosis of subtrochanteric or diaphyseal femur fractures
- •Hemodynamic instability
- •Known diagnosis of severe cognitive impairment
- •Dementia and/or delirium (defined by a 4AT score ≥ 2)
- •Lack of capacity to provide consent and to understand the aim of the study
- •Body weight < 40 Kg
- •Prior hip surgery on the same fracture side
- •Mild worst pain (visual analogue scale, VAS < 40 mm) (at rest or dynamic)
结局指标
主要结局
Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID)
时间窗: Outcome assessed within 60 minutes following the block (PENG or FIB)
Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID) (derived from V AS measurement at T0-T1- T2-T3-T4 as described above)
次要结局
- 33% SPID 33% (33%SPID)(Outcome assessed within 60 minutes following the block (PENG or FIB))
- Quantity of opioids(Outcome assessed within 60 minutes following the block (PENG or FIB))
- 50%SPID(Outcome assessed within 60 minutes following the block (PENG or FIB))
- Adverse events(Outcome assessed within 60 minutes following the block (PENG or FIB))
研究者
Santi Di Pietro
MD, PhD - Emergency Medicine Consultant
Fondazione IRCCS Policlinico San Matteo di Pavia