Comparing Fascia Iliaca Compartment Block With Pericapsular Nerve Group Block for Hip Fracture Pain Control Before Operation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain measurement at rest
研究概览
简要总结
The aim of the study is to compare the analgesic effect of fascia iliaca compartment block (FIC) block and pericapsular nerve group (PENG) block in hip fracture pain control. The participants, caregivers, and assessors will be blinded to the type of block the participants receive. Patients aged 20 years or older with hip fracture scheduled for surgical treatment will be assessed for eligibility to participate the study. One hundred eligible patients will be included in the study after informed consents are obtained, and then randomly allocated into either FIC block or PENG block, with 50 patients in each group. Both blocks will performed under ultrasound guidance.
The followings will be assessed: the numerical rating pain scale (NRS 0-10, 0: no pain, 10: worst pain imaginable) at before and after nerve block at different time points during rest and passive internal rotation of the fractured lower limb to neutral position from its typical external rotation deformity 30 mins after block (primary outcome). The degree of patient's satisfaction regarding nerve blocks and anesthesiologist's satisfaction regarding patient position during spinal anesthesia will also be assessed. The pain and use of rescue analgesics in the first 24 hours after operation will be recorded.
详细描述
The aim of this study is to compare the analgesic effect of fascia iliaca compartment block (FIC) block and pericapsular nerve group (PENG) block in hip fracture pain control before operation.
Methods This will be a randomized, assessor and participant-blinded study. After the patients give his /her informed consents, his/her baseline demographic data (gender, age, height, and body weight) and types of hip fracture will be recorded. Participants will be randomly allocated into either FIC block or PENG block by using the website RESEARCH RANDOMIZER (https://www.randomizer.org). One of the two anesthesiologists experienced in performed the FIC and PENG blocks will perform the nerve blocks. Only the anesthesiologist performing the nerve block and his assistant will be aware of which nerve block the participant receives immediately before performing nerve block by opening a sealed envelope. The assessors, in-charge anesthesiologists and nurse anesthetists, operation room personnel, surgeons and study participants will be all blinded to the randomization.
On arrival of the operating theater, all participants will be sent to the nerve block area, where continuous electrocardiogram, pulse oximetry, and non-invasive intermittent blood pressure monitoring will be applied and an intravenous line will be established. Before any intervention, pain at rest and during the fractured lower limb being passively internal rotated in extension to neutral position from its usual externally rotated deformity by assessors will assessed using NRS. If the participant cannot tolerate passive internal rotation of his/her fractured limb due to pain, impossibility to perform the test will be recorded as well as the worst NRS score during these attempts. The same assessment will be performed every 10 mins for until 30 mins after completion of the nerve block. Then the patient will be sent to the operation room, where spinal anesthesia will be performed for the surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for surgical treatment for hip fracture
- •American Society of Anesthesiologists (ASA) physical status I-III
排除标准
- •allergy to local anesthetics
- •pregnancy
- •inability to understand and use the numerical rating scale (NRS 0-10, 0: no pain, 10: worst pain imaginable) after instruction
- •chronic use of opioids
- •coagulopathy
- •neuropathy
- •severe diabetic mellitus
研究组 & 干预措施
Fascia iliaca compartment block
Participants will receive fascia iliaca compartment block before spinal anesthesia and operation
干预措施: Fascia iliaca compartment block (Procedure)
Pericapsular nerve group block group
Participants will receive pericapsular nerve group block before spinal anesthesia and operation
干预措施: Pericapsular nerve group block (Procedure)
结局指标
主要结局
Pain measurement at rest
时间窗: 30 minutes after nerve blocks
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) at rest
Pain measurement during internal rotation
时间窗: 30 minutes after nerve blocks
Numerical pain rating scale (0-10, 0: no pain, 10: worst pain imaginable) during the fractured limb being passively internally rotated to neutral position from usual externally rotated deformity
次要结局
- the time spending for nerve block(Before operation)
- Pain measurement at rest(20 minutes after nerve block)
- pain measurement during positioning for spinal anesthesia(Just before operation)
- the time spending for performing spinal anesthesia(Just before operation)
- Pain measurement during internal rotation(20 minutes after nerve block)
- pain measurement after operation(6, 12, and 24 hours after operation)
- the first time of pain perceived by the patient after operation(Within 48 hours after operation)
- the first time of ambulation after operation(Within 72 hours after operation)
- quality of position for spinal anesthesia(Just before operation)
- the time of first request for rescue analgesics after operation(Within 48 hours after operation)
- total consumption of rescue analgesics within 24 hours after the operation(Within 24 hours after the operation)
研究者
Sheng-Chin Kao
Attending physician, Department of Anesthesiology, Principal investigator,
Mackay Memorial Hospital