Regional Anesthesia in Hip Arthroplasty- Comparison Between Two Techniques for Erector Spinae Plane Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- sensory block
研究概览
简要总结
Diffusion of local anesthetics after a lumbar ESPB within fascial planes towards nerve structures is a matter of debate.
The main objective of the study is to compare the incidence of sensory block between two techniques of needle placement (superficial or translaminar) during lumbar ESPB block.
Patients are treated with lumbar ESPB (randomized to superficial or translaminar), spinal anesthesia and multimodal analgesia.
The primary endpoint will be the incidence of numbness/reduced skin sensitivity to cold (ice test) in the area innervated by the lumbar plexus. Secondary outcomes are pain and analgesic's consumption, motor block, quality of recovery and discharge ability.
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
- Single (Outcomes Assessor)
盲法说明
outcome assessor will not be aware of the technique used in the OR
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
- •primary total hip replacement
- •informed consent
排除标准
- •allergies to study drugs
- •spinal anesthesia contraindicated
- •kidney failure (GFR<30)
- •epilepsy, psychiatric disease, neurologic deficits
- •revision surgery
- •neuropathies in the lumbar area (tingling, hypoestesia, numbness, motor deficit)
- •no informed consent
- •pregnancy
- •alcohol/opioid abuse
- •emergency surgery/intensive care
研究组 & 干预措施
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
干预措施: spinal anesthesia (Procedure)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
干预措施: Ibuprofen 400 mg (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
干预措施: Dexamethasone (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
干预措施: Ibuprofen 400 mg (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
干预措施: Paracetamol (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
干预措施: Morphine (Drug)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
干预措施: deep (inter laminar) erector spinal plane block (ESPB) (Procedure)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
干预措施: Dexamethasone (Drug)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
干预措施: Paracetamol (Drug)
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
干预措施: Morphine (Drug)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
干预措施: spinal anesthesia (Procedure)
superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
干预措施: superficial erector spinal plane block (ESPB) (Procedure)
结局指标
主要结局
sensory block
时间窗: 24 hours
incidence of reduced or abolished cold sensation on the skin in the territory of lumbar plexus (anterior, medial and lateral thigh)
次要结局
- motor block(24 hours)
- postoperative pain(48 hours)
- morphine consumption(24 hours)
- quality of recovery(48 hours)
- complications(48 hours)
- discharge ability(48 hours)
- motor block(24 hours)
- postoperative pain(48 hours)
- morphine consumption(24 hours)
- quality of recovery(48 hours)
- complications(48 hours)
- discharge ability(48 hours)
研究者
Dario Bugada
MD
Papa Giovanni XXIII Hospital