Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 346
- 试验地点
- 7
- 主要终点
- Amount of morphine
研究概览
简要总结
This national, prospective, multicenter, randomized study aims to reduce the amount of intravenous morphine (titration + PCA morphine) during the first 24 postoperative hours via a locoregional anesthesia technique in patients undergoing throat and neck cancer surgery.
详细描述
The incidence of throat and neck (ENT) cancers is 15000 new cases/year in France. Nowadays, there are no studies with a sufficient level of evidence to establish formal recommendations on analgesic treatments to be applied in the context of ENT cancer surgery.
As cancer surgery causes severe acute postoperative pain and chronic pain, loco-regional anesthesia (LRA) plays an increasingly role in the prevention of this type of pain.
However, nowadays there is no data in the literature highlighting the interest of LRA in the context of ENT cancer surgery, despite a significant theoretical benefit.
The superficial cervical block, already used in carotid or thyroid surgery, has already shown its value. It seems logical to propose this block in throat and neck cancer surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient undergoing ENT cancer surgery with cervicotomy
- •Adult patient having received oral information from a doctor and signed written consent
- •Affiliation to a social security scheme, Universal Medical Coverage (CMU)
排除标准
- •Patient refusal
- •Altered mental faculties or patient unable to give consent
- •Allergy to local anesthetics
- •Severe respiratory pathology (altered respiratory function tests with 50% < FEV1 < 80%, FEV1/FVC < 70%, COPD stage 2 or more)
- •Preoperative SpO2 less than 92% in ambient air
- •Left heart failure NYHA 3 or more, impaired LVEF < 30% or less
- •Lower respiratory infection in the month preceding surgery
- •History of ENT cancer surgery with cervical lymph node dissection
- •Pregnant or breastfeeding woman
- •Patient under AME
- •Patient under guardianship or reinforced curatorship
- •Participation in other interventional research
研究组 & 干预措施
Naropeine Arm
Superficial cervical plexus block with 0.2 % ropivacaine (Naropeine)
干预措施: Cervical plexus block with 0.2 % Naropeine (Procedure)
Placebo Arm
Superficial cervical plexus block with 0.9 % saline placebo
干预措施: Cervical plexus block with saline placebo (Procedure)
结局指标
主要结局
Amount of morphine
时间窗: The first 24 hours postoperatively
The analysis metric is the cumulative amount of IV morphine (amount of morphine titrated in SSPI + administered by PCA in mg and mg/kg/day) during the first 24 hours postoperatively.
次要结局
- Evaluation in cervical VAS and flap site VAS score(On arrival, 1 hour later, 2 hours later, 4 hours later)
- The length of time spent in hospital(Duration of hospital stay assessed up to 15 days or hospital discharge)
- Evaluation of the E Satis MSO FNAH score(Day 15 (or hospital discharge))
- Remifentanil consumption(Intraoperative)
- Consumption of morphine(In the first 72 hours postoperatively)
- Evaluation in cervical VAS in dynamic conditions and flap site VAS score(Day 1, day 15 (or hospital discharge), 1 month and 3 months)
- Evaluation of adverse effects attributable to morphine consumption(Day 1, Day 15 (or hospital discharge))
- Evaluation of the rate of patients with early rehabilitation(Initiated on Day 1)
- DN4 score assessment(Day 1, Day 15 (or hospital discharge), 1 month and 3 month)
- Evaluation of the Mc Gill Pain score (SF-MPQ-2)(Day 1, day 15 (or hospital discharge), 1 month and 3 months)