Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery (BCS-ORL)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: ENT Cancers

Treatments: Procedure: Cervical plexus block with saline placebo; Procedure: Cervical plexus block with 0.2 % Naropeine

Study type: Interventional

Funder types: Other

Identifiers

NCT07110857

2024-510942-15-00 (EU Trial (CTIS) Number)

PHRCI-2022-38 (Other Grant/Funding Number)

APHP230866

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 346 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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346 participants in 2 patient groups, including a placebo group

Naropeine Arm

Experimental group

Description:

Superficial cervical plexus block with 0.2 % ropivacaine (Naropeine)

Treatment:

Procedure: Cervical plexus block with 0.2 % Naropeine

Placebo Arm

Placebo Comparator group

Description:

Superficial cervical plexus block with 0.9 % saline placebo

Treatment:

Procedure: Cervical plexus block with saline placebo