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ClinicalTrials.gov ID

NCT07110857

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

346Estimated

Last Update Posted

Aug 8, 2025Actual

Start Date

Sep 2025Estimated

Primary Completion Date

Jun 2027Estimated

Completion Date

Sep 2027Estimated

Official Title

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

Brief Summary

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.

Detailed 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.

• ENT Cancers

• Cervical plexus block with 0.2 % Naropeine
• Cervical plexus block with saline placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Ministry of Health, FranceOTHER_GOV

laetitia.desplanque@aphp.fr