Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- FQoR-15 score at 24 hours
研究概览
简要总结
Opioid-Free Anesthesia (OFA) is an anesthesia protocol that does not use morphine, and is increasingly used routinely. Indeed, this protocol would theoretically allow a better post-operative analgesic control, a lower incidence of post-operative complications (e.g. post-operative nausea and vomiting). In the end, it would also allow a better overall post-operative recovery and a decrease in the incidence of chronic post-operative pain.
Nevertheless, the literature is poor on this issue and no randomized controlled study has evaluated the effect of the use of this type of anesthesia protocol on postoperative recovery.
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 (Participant)
盲法说明
The arm allocation is open for the anesthesia team and caregivers but the patient is blind.
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
- •Age > 18 years
- •Surgery lasting more than 90 minutes with planned use of morphine analgesics during post-operative hospitalization (outside the PACU stay),
- •ENT surgery, plastic and reconstructive surgery, digestive and visceral surgery, urological surgery and gynecological surgery,
- •Surgery that does not involve any bone procedure,
- •Written consent of the patient,
- •French-speaking patient, able to understand and answer a questionnaire,
- •Social security affiliation
排除标准
- •Pregnant, breastfeeding or parturient woman,
- •Person deprived of liberty by judicial or administrative decision,
- •A person who is subject to a legal protection measure,
- •Person unable to express consent,
- •BMI < 18 and > 39 kg/m2,
- •Drug contraindications, in particular hypersensitivity to the active substances of one of the study drugs (in particular lidocaine hydrochloride or amide- or clonidine-linked local anaesthetics) or to one of the excipients,
- •Porphyria,
- •Heart failure or unstable coronary artery disease,
- •bradyarrhythmia due to sinus node disease or conduction clock, or Adam-Stock's syndrome, not fitted,
- •Hepatocellular insufficiency with TP < or =50%,
- •Chronic renal failure with glomerular filtration < 60 ml/min.
- •Long-term treatment with Imipraminics, Neuroleptics, Baclofen, and all other molecules at risk of QT prolongation,
- •Uncontrolled epilepsy,
- •Chronic treatment with beta-blockers,
- •Need for induction in fast sequence,
- •Severe psychiatric or cognitive disorder that interferes with the evaluation through questionnaires.
研究组 & 干预措施
Opioid free anesthesia (OFA) protocol
干预措施: Opioid Free Anaesthesia protocol (Drug)
standard practice protocol based on the use of opioids (sufentanil or remifentanil)
干预措施: standard practice protocol based on the use of opioids (sufentanil or remifentanil) (Drug)
结局指标
主要结局
FQoR-15 score at 24 hours
时间窗: 24 hours after surgery
Value of the French Quality of Recovery-15 score (minimum value of 0 and maximum value of 150, with a higher score for a better outcome). The QoR-15 questionnaires will be completed by the patient himself whenever possible, who could be helped by a nurse blinded to the assignment group, or by phone if the patient has returned home.
次要结局
- Proportion of patients with chronic pain at 3 months(3 months)
- FQoR-15 score at 48 and 72 hours(48 and 72 hours after surgery)
- Pain on effort at 6, 12, 24, 48 and 72 hours(6, 12, 24, 48 and 72 hours after surgery)
- Opioid consumption(7 days)
- anesthesiologist satisfaction at day 1(day 1)
- Proportion of patient with at least one POMS complication at 24, 48 and 72 hours(24, 48 and 72 hours)
- Incidence of hemodynamic, rhythmic and allergic complications at day 1(day 1)
- Surgeon satisfaction at day 1(day 1)
- Quality of life measured from EQ VAS (EQ-5D-3L)(3 months)
- Proportion of neuropathic pain at 3 months(3 months)
- Proportion of respect of the allocated anesthesia protocol(24 hours after surgery)