Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Cervical plexus block with 0.2 % Naropeine
  Under ultrasound guidance, a superficial cervical plexus block is performed immediately after induction and before skin incision by injecting 15-25 mL of 0.2 % ropivacaine (Naropeine) uni- or bilateral depending on the surgical incision
• Процедура Cervical plexus block with saline placebo
  Under ultrasound guidance, a superficial cervical plexus block is performed immediately after induction and before skin incision by injecting 15-25 mL of 0.9 % saline uni- or bilateral depending on the surgical incision

Первичные конечные точки

• Amount of morphine [Срок оценки: The first 24 hours postoperatively]

Вторичные конечные точки (10)

• Remifentanil consumption [Срок оценки: Intraoperative]
• Consumption of morphine [Срок оценки: In the first 72 hours postoperatively]
• Evaluation in cervical VAS and flap site VAS score [Срок оценки: On arrival, 1 hour later, 2 hours later, 4 hours later]
• Evaluation in cervical VAS in dynamic conditions and flap site VAS score [Срок оценки: Day 1, day 15 (or hospital discharge), 1 month and 3 months]
• DN4 score assessment [Срок оценки: Day 1, Day 15 (or hospital discharge), 1 month and 3 month]
• Evaluation of adverse effects attributable to morphine consumption [Срок оценки: Day 1, Day 15 (or hospital discharge)]
• Evaluation of the rate of patients with early rehabilitation [Срок оценки: Initiated on Day 1]
• The length of time spent in hospital [Срок оценки: Duration of hospital stay assessed up to 15 days or hospital discharge]
• Evaluation of the E Satis MSO FNAH score [Срок оценки: Day 15 (or hospital discharge)]
• Evaluation of the Mc Gill Pain score (SF-MPQ-2) [Срок оценки: Day 1, day 15 (or hospital discharge), 1 month and 3 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 7 центров

• CHU de Lille- Hôpital Roger Salengro — Lille
• Assistance publique - Hôpitaux de Marseille — Marseille
• AP-HP - Hôpital Lariboisière — Paris
• Assistance publique - Hôpitaux de Paris — Paris
• CHU Charles Nicolle — Rouen
• hôpital Foch — Suresnes
• Institut Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT07110857 · APHP230866 · PHRCI-2022-38 · 2024-510942-15-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗