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Clinical Trials in France / NCT07110857
Starting soon Not applicable

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

NCT07110857 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2025-09
Last updated
2025-08-08

Condition(s) studied

ENT Cancers

Investigational drug(s) / intervention(s)

Cervical plexus block with 0.2 % NaropeineCervical plexus block with saline placebo

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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 outcome measure(s)

  • Amount of morphine — 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.

Trial sites (7)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07110857 on ClinicalTrials.gov ↗ ← All trials in France