Erector Spinae Plane Block Efficacy Versus Intravenous Morphine for Postoperative Pain Control Following Vertebral Fixation Surgery Via Posterior Approach: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Postoperative morphine consumption
研究概览
简要总结
The study aims to shed light about the potential role of Erector Spinae Block in the management of postoperative pain following vertebral fixation surgery via posterior approach. Patients will be randomized, the block will be performed before inducing general anesthesia, intraoperative management will be uniformed, while postoperative analgesia will compare cases (patients who received the block) versus controls (usual care with endovenous morphine infusion only).
详细描述
The study is a single-centre, interventional, prospective, case-control study. After being informed about the study and potential risks during preoperative anaesthetic evaluation, all patients giving written informed consent will be enrolled in the study.
Inclusion criteria will be: patients undergoing vertebral fixation via posterior approach both for degenerative or traumatic causes, age 18-85, American Society of Anesthesiologists (ASA) I-III, written informed consent signed. Exclusion criteria will be: patients outside the 18-85 year old range, allergies or contraindications to the use of local anaesthetics and erector spinae block, skin infections at the puncture site, body-mass index above 40.
The initial estimate of patients needed to detect statistically significant results has been estimated in 30 (15 cases versus 15 controls). Considering the surgical activity in the organising centre, the study should be completed before the end of 2021. Randomization will be made with a random sequence informatically produced. The study will be double-blinded, with the patient, the nurse doing the postoperative pain assessment and the statisticians not knowing the type of anaesthesia performed (only the anesthesist in the operating theatre is unblinded).
Erector spine plane (ESP) block will be performed after general anaesthesia (GA) induction, with the patient already in prone position. It will be made at the vertebral level of surgical fixation, bilaterally, with Ropivacaine 0.4% and dexamethasone 4 mg in 20 mL of sodium chloride (NaCl) 0.9% per side. GA will be induced with propofol, fentanyl and rocuronium to all patients, while GA maintenance will be performed with total-intravenous anaesthesia (TIVA) with propofol and boluses of fentanyl as required. Basic blood pressure, pulse-oximetry, electrocardiogram, train-of-four, body temperature and bispectral index monitoring will be applied to every patient. At the end of the surgery all the patients will receive a bolus of acetaminophen 1 g and morphine 4 mg.
Post-operative analgesia in controls will be performed by patient-controlled analgesia (PCA) pumps infusing boluses-at-request of morphine 1 mg (maximum once every 15 minutes) with no background infusion, plus acetaminophen 1 g every 8 hours for the first 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Care provider (anaesthetist) will know the type of anaesthesia performed. Outcome assessor (physician visiting the patient postoperatively) and investigator (study design and data analysis) will not know the type of anaesthesia performed.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II-III
- •written informed consent signed
- •traumatic or degenerative disease
- •adult age (18-65 year old)
排除标准
- •allergies to local anesthetics
- •contraindications to ESP block execution
- •congenital or drug-induced coagulopathies
- •infections at the puncture site
- •BMI > 40
研究组 & 干预措施
Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphine
Preoperative bilateral ESP block with ropivacaine 0,4% + dexamethasone 4 mg, 20 mL per side, at the median spinal level of intervention.
End-surgery: acetaminophen 1 g ev + 4 mg morphine ev before the end of the intervention.
PCA: morphine 1 mg, max every 30 minutes. Rescue: ketoprofen 100 mg ev, max three times per day.
干预措施: Erector Spinae plane Block (Procedure)
Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphine
Preoperative bilateral ESP block with ropivacaine 0,4% + dexamethasone 4 mg, 20 mL per side, at the median spinal level of intervention.
End-surgery: acetaminophen 1 g ev + 4 mg morphine ev before the end of the intervention.
PCA: morphine 1 mg, max every 30 minutes. Rescue: ketoprofen 100 mg ev, max three times per day.
干预措施: Patient controlled analgesia with intravenous morphine (Drug)
Patient controlled analgesia (PCA) with intravenous morphine
End-surgery: acetaminophen 1 g ev + 4 mg morphine ev before the end of the intervention.
PCA: morphine 1 mg, max every 30 minutes. Rescue: ketoprofen 100 mg ev, max three times per day.
干预措施: Patient controlled analgesia with intravenous morphine (Drug)
结局指标
主要结局
Postoperative morphine consumption
时间窗: 48 hours
Milligrams of morphine used to control postoperative pain
次要结局
- In-hospital length-of-stay(2-6-12-24-36-48 postoperative hours)
- Postoperative agitation-sedation-delirium(2-6-12-24-36-48 postoperative hours)
- Postoperative pain control(2-6-12-24-36-48 postoperative hours)
- Intraoperative opioid use(Intraoperative)
- Patients satisfaction(at 48 postoperative hours)