NCT05439005招募中3 期
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 3
- 主要终点
- comparison of Morphine consumption in the two groups
研究概览
简要总结
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 or older.
- •Patients with a French health insurance coverage (having a French social security number).
- •Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.
- •Patient who has given written consent to participate in accordance with the regulations.
- •Having a negative blood pregnancy test for patients of childbea ring age.
排除标准
- •Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).
- •Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
- •Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.
- •Treatment with ACEI/ARB.
- •Severe asthma.
- •Symptomatic gastric or duodenal ulcer with or without treatment.
- •Baseline systolic blood pressure < 100 mmHg.
- •Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.
- •Patient already included in another therapeutic trial evaluating an experimental molecule.
- •Persons deprived of liberty or under guardianship.
- •Patients with suspected difficulties in assessing pain on a scale.
- •Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.
研究组 & 干预措施
OFA group
Experimental
OFA (Opioid Free Anaesthesia) group:
干预措施: Dexmedetomidine (Drug)
CA control group
No Intervention
CA (Conventional Anaesthesia) control group:
结局指标
主要结局
comparison of Morphine consumption in the two groups
时间窗: during the first 48 hours postoperatively
次要结局
- Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2(in the PACU, at D0, D1 and D2)
- Pain management satisfaction scores (score from 0 to 10) at discharge(at discharge)
- Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary);(the first 48 hours postoperatively)
- Dose of morphine given in titration in the PACU (mg)(in the PACU)
- DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6(on D2, D4, M1, M3 and M6)
- Collection of serious adverse events between D0 (date of surgery) and D30(between D0 (date of surgery) and D30)
- Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate(at discharge)
- Dose of intraoperative rescue remifentanil in the OFA group (mcg)(at discharge)
- Assessment of vasopressor requirement and total intraoperative filling volume(end of surgery)
- Assessment of the state of consciousness on arrival in the PACU(on arrival in the PACU)
- Number of boluses demand on PCA during the first 48 hours postoperatively(the first 48 hours postoperatively)
- Assessment of the incidence of PONV in the PACU, at D0, D1 and D2(in the PACU, at D0, D1 and D2)
- Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)(at discharge)
研究者
研究点 (3)
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