2023-504204-28-00招募中4 期
Evaluation of the postoperative analgesic efficacy of erector spinae plane block in lumbar spinal surgery: a prospective randomized double-blind study
CHU De Liege2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年9月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- The primary objective will define wether or not ESPB is effective at reducing opioid consumption, in morphine oral equivalent, during the first 24 hours postoperatively
研究概览
简要总结
Post-operative morphine consumption after lumbar arthrodesis with and without erector spinae plane block
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •All genders aged from 18 to 85 years old
- •Scheduled for lumbar arthrodesis surgery 1 to 3 levels
排除标准
- •A BMI <18 or > 35 or weight < 50kg
- •Kidney or liver failure
- •Uncontrolled hypertension at home or requiring more than 2 anti-hypertensive treatments
- •Minimally invasive surgery with unilateral approach, percutaneous or without laminectomy
- •Allergy to one or more of the medications used in the study
- •Chronic pain (chronic medication and/or presence of a neurostimulator), fibromyalgia, psychiatric disorders, alcoholism and/or chronic use of strong opioids (considered chronic if taking a strong opioid on a daily basis for > 1 week) preoperatively
- •A contraindication to a loco-regional anesthesia technique
- •Refusal of consent by the patient
结局指标
主要结局
The primary objective will define wether or not ESPB is effective at reducing opioid consumption, in morphine oral equivalent, during the first 24 hours postoperatively
The primary objective will define wether or not ESPB is effective at reducing opioid consumption, in morphine oral equivalent, during the first 24 hours postoperatively
次要结局
- Analysis of intraoperative parameters (blood pressure, heart rate, Response and State Entropy (RE/SE), Surgical Plethysmographic Index (SPI) at the time of the block, during incision and at extubation.
- Absence of complications related to the block
- Opioid use in the PACU
- Level of drowsiness in PACU (RASS score)
- Pain scores at different time intervals from PACU to hospital discharge
- Length of hospitalization
- Assessment of the quality of postoperative recovery using the QoR-15 score at PCA withdrawal
- Presence of PONV, constipation, pruritus
研究者
Dr TRAN Gabriel
Scientific
CHU De Liege
研究点 (2)
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