Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Oxycodone consumption
研究概览
简要总结
Spinal surgery is associated with intense pain and associated to a history of preoperative chronic pain. Pregabalin is licensed to treat chronic neuropathic pain, particularly when high dose of opioid are required. Preoperative pain is associated with high postoperative pain scores and opioid requirement promoting persistent hyperalgesic state. The investigators will evaluate the postoperative opioid consumption and pain scores in patients scheduled for lumbar surgery and taking pregabalin since more than 15 days and compare with preoperative pregabalin-free patient that will receive pregabalin only during surgery.
详细描述
Patients will be prospectively included and compared according their preoperative medication: pregabalin-treated patients (>more than 15 days) for neuropathic pain associated to spinal surgery and pregabalin-free patients for whom pregabalin will be prescribed for 48 hours. Patients will be included without randomization as an observational study. All the patients will receive multimodal analgesia and intraoperative management will be standardized. The main outcome will be the amount of oxycodone during the first 24h after surgery. Other outcomes include pain scores, the quantification of the neuropathic pain diagnostic questionnaire (DN4), nausea and vomiting, length of stay, side-effects of pregabalin and opioid. Patients were also evaluated at three months for pain scores and DN4 score. Postoperative evaluation will be performed in a single-blind manner with investigators not include in the recruitment or the peroperative period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •American Society Anesthesiologist Physical status (ASA) 1-3
- •Age ≥18 years old
- •Spinal surgery: discectomy, posterior or transforaminal lumbar interbody fusion limited to 2 levels, lumbar disk prosthesis
- •Able to participate personality, has given free and inform consent in French
- •Affiliated of beneficiary of a system of social security
排除标准
- •Age less than 18 years or higher than 85 years old
- •Refusal to participate or provide written consent
- •Surgery with a combined anterior and posterior approach
- •Emergency surgery, reintervention, spine fracture, metastasis
- •Tricyclic antidepressant use
- •Pregabalin use for other indication: other neuropathy, epilepsy, generalized anxiety disorder
- •Pregnancy
- •Lack of understanding of NRS and/or DN4 scores
- •Hypersensibility or contraindication to levobupivacaine, paracetamol, nefopam, ketoprofen and/or oxycodone
- •Participation in another clinical study
研究组 & 干预措施
Pregabalin patients
Same dose of preoperative pregabalin 1h after surgery associated to paracetamol 1g PO and ketoprofen 100mg PO Intraoperative: nefopam 20mg IV + ketamine 0.3mg/kg IV + dexamethasone 8mg IV Postoperative: morphine titration (PACU if NRS > 3) + paracetamol 1g/6h PO + ketoprofen 100mg/12h PO systematically, oxycodone 5-10mg/12h PO if NRS>3
干预措施: Pregabalin (Drug)
Naive patients
Pregabalin 150mg PO initiated 1h before surgery and associated to paracetamol 1g PO and ketoprofen 100mg PO Intraoperative: nefopam 20mg IV + ketamine 0.3mg/kg IV + dexamethasone 8mg IV Postoperative: morphine titration in PACU (NRS > 3) + paracetamol 1g/6h PO + ketoprofen 100mg/12h PO systematically, oxycodone 5-10mg/12h PO if NRS>3
干预措施: Naive patient (Other)
结局指标
主要结局
Oxycodone consumption
时间窗: 24h postoperatively
mg
次要结局
- remifentanil consumption(during surgery)
- Oxycodone requirement(0-48h after surgery)
- Numeric Rating Scale Pain (NRS) during walking(3 months ater surgery)
- Morphine titration(0-2h after surgery)
- Ondansetron requirement(0-48h after surgery)
- DN4 score(three months after surgery)
- length of stay(on postoperative day five)
- Post Opertive Nausea and vomiting (PONV)(0-48h after surgery)
- Numeric Rating Scale (NRS) Pain at rest(the day before surgery)
- Numeric Rating Scale (NRS) Pain during walking(the day before surgery)
- Numeric Rating Scale Pain (NRS) at rest(3 months after surgery)
- Pregabalin side-effects(0-48h after surgery)
- Sedation(0-48h after surgery)
研究者
Christophe Aveline, MD
Principal investigator: Christophe Aveline, Department of anesthesia and surgical intensive care unit, Private Hospital
Private Hospital Sevigne