Evaluation of the PENG Block vs Placebo for Preoperative Pain Control in Hip Fractures in the Elderly - a Double-blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dynamic pain scores (Numerical pain score (NRS) at 15 degrees leg lift)
研究概览
简要总结
Hip fracture pain is often severe and traditionally managed by systemic opioids which have increased risk of side effects in frail elderly patients. Inadequately controlled pain may lead to delirium which increases mortality and morbidity. The overall aim of this RCT is to investigate the potential for improved pain relief accomplished by the addition of the PENG block to current standard practice of pre-operative analgesia (systemic morphine), compared to the control group, which involves no block (operator will still go through the motion as if performing a block) plus standard pre-operative analgesia.
The investigator hypothesize that the addition of a single shot PENG block at the side of hip fracture in addition to traditional systemic morphine provides good preoperative pain relief on movement and reduces the need for breakthrough opioid requirements. The investigator hypothesize that the interventional group dynamic pain score assessed at 30 minutes after the block compared to control group dynamic pain score at 30 minutes after the "block" will be at least a 3 point difference between the 2 groups .
详细描述
Specific Aim1: To determine difference in pain scores on movement (dynamic pain scores) in patients who receive the PENG block in the intervention group compared to no block in the control group at 30 minutes after performance of the block.
Specific Aim2: To determine if there is any difference in pain at rest between the intervention group and the control group, and if so, the magnitude of the difference in pain scores.
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, Outcomes Assessor)
盲法说明
Patient, nurses and CRC will be blinded. Rest of study team is not blinded.
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years old and above
- •Provided consent for the study
- •Patients with solitary hip fracture (no other fracture) - intracapsular neck of femur fracture, intertrochanteric fracture
- •Either awaiting hip fracture surgery or no plans for hip fracture surgery within the next 24 hours
排除标准
- •Patients with cognitive impairment or inability to give consent, or refusal to give consent
- •Multiple fracture cases
- •Peri-prosthetic fractures and revisions
- •Subclinical vertebral fractures
- •Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters
- •Multiple trauma
- •Pathological fractures secondary to metastases
- •Patients with contraindications to block performance
- •Coagulopathy as demonstrated by PT/PTT/INR
- •On antiplatelets or anticoagulation
- •Infection/ compromised skin integrity at site of block performance
- •Allergy to local anaesthetics and opioids
研究组 & 干预措施
Control
Only standard care
干预措施: Placebo (Drug)
Intervention group
The PENG block was performed for intervention group with local anaesthetic solution composed of 20 ml of ropivacaine 0.5%.
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
结局指标
主要结局
Dynamic pain scores (Numerical pain score (NRS) at 15 degrees leg lift)
时间窗: 30 minutes after receiving intervention
The difference in dynamic pain scores (NRS at 15 degrees leg lift) at 30 minutes post block performance in the intervention group vs the control group. Assessment of the dynamic pain score is done prior to discharge from recovery at SGH Pain Management Centre.
次要结局
- Total opioid use over 24 hours as a surrogate measure(Up to 24 hours from performance of block)
- Pain scores (NRS) at rest (static pain) and on movement (dynamic pain)(Up to 24 hours from performance of block)
- Pain scores collected to estimate the onset and duration of block Pain scores to estimate the onset and duration of block(Up to 24 hours from performance of block)