Evaluation of Superficial Cervical Plexus Block with Ropivacaine and Sodium Chloride in Oncological Throat and Neck Surgery

The primary objective of this study is to evaluate the **reduction** in the quantity of intravenous (IV) morphine, including titration and patient-controlled analgesia (PCA) morphine, during the first 24 postoperative hours. This is achieved through the use of a locoregional anesthesia technique in patients undergoing throat and neck cancer surgery. The clinical relevance of this objective lies in potentially minimizing opioid consumption, thereby reducing opioid-related side effects and improving postoperative recovery.

Secondary objectives include:

• Reduction in intraoperative remifentanil consumption per unit of time (in µg/kg/min).
• Reduction in consumption of morphine equivalent IV or PO in the first 72 hours postoperatively.
• Reduction in VAS-cervical scores on arrival, at H+1, H+2, and H+4.
• Reduction in cervical VAS scores at rest on D1, D15, hospital discharge, 1 and 3 months.
• Reduction in VAS scores on mobilization on D1, D15, and discharge from hospital.
• Reduction in DN4 scores on D1, D15, hospital discharge, 1 and 3 months.
• Evaluation of adverse effects attributable to locoregional anesthesia (LRA).
• Evaluation of adverse effects attributable to morphine consumption, such as desaturation and nausea-vomiting, on D1, D15, and discharge from hospital.
• Evaluation of the rate of patients with early rehabilitation, including verticalization, chair use, and physiotherapy, initiated on D1.
• Record of length of hospitalization.
• Statement of Esatis MCO HAS score (item: "care") upon discharge from hospital.
• Record of the Mc Gill Pain score (SF-MPQ-2) on D1, on discharge from hospital, 1 and 3 months.

The clinical trial involves **adult patients** undergoing throat and neck cancer surgery, specifically those requiring cervicotomy. The study population includes both male and female participants, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not focus on a vulnerable population. Participants were selected based on their scheduled **ENT cancer surgery** and their ability to provide informed consent, as well as their affiliation with a social security scheme or Universal Medical Coverage (CMU). The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data. Key inclusion criteria include being an adult patient undergoing the specified surgery and having received oral information from a doctor, followed by signing written consent. The trial aims to evaluate the reduction in the quantity of IV morphine used during the first 24 postoperative hours through a locoregional anesthesia technique.

The clinical trial is designed to evaluate the efficacy of a **superficial cervical plexus block** in reducing the quantity of intravenous morphine required during the first 24 postoperative hours in patients undergoing throat and neck cancer surgery. This study employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The trial is expected to commence recruitment on April 1, 2025, and conclude by June 30, 2027. Participants will be involved in the study for a maximum treatment period of one day, with the primary endpoint being the quantity of morphine consumed postoperatively.

Study visits are structured to include an initial inclusion (screening) visit, where eligibility is confirmed based on criteria such as being an adult patient undergoing ENT cancer surgery with cervicotomy, having received oral information from a doctor, and having signed written consent. Follow-up visits will monitor the administration of the investigational products, **sodium chloride** and **ropivacaine**, both delivered via injection. The end-of-study visit will assess the primary endpoint and ensure the safety and well-being of the participants.

Participants are expected to remain in the study for the duration of the treatment period unless conditions arise that necessitate early termination, such as adverse reactions or withdrawal of consent. The trial's methodology ensures that all procedures adhere to ethical standards and regulatory requirements, with the primary focus on patient safety and the scientific integrity of the data collected.

The clinical trial involves the administration of **SODIUM CHLORIDE** as a **solution for injection**. This experimental medication is utilized in the study as a placebo. The **sodium chloride** solution is administered via injection, with a maximum daily dose of 50 ml. The total dose is also limited to 50 ml, and the treatment period is restricted to one day. The solution is of chemical origin and is not formulated for pediatric use. Compliance with the dosing schedule is monitored to ensure adherence to the protocol.

**ROPIVACAINE** is the primary experimental medication used in this clinical trial. It is also provided as a **solution for injection**. The administration route is via injection, with a maximum daily dose of 100 mg. The total dose is similarly capped at 100 mg, and the treatment duration is limited to one day. **Ropivacaine** is a chemically derived substance and is not intended for pediatric formulations. Participant compliance with the dosing regimen is closely monitored to maintain the integrity of the study.

The efficacy of the clinical trial titled "BCS-ORL - Evaluation of the superficial cervical plexus block in oncological throat and neck surgery" will be assessed primarily through the measurement of the quantity of intravenous (IV) morphine consumed postoperatively. This includes the total amount of morphine titrated in the postoperative room and administered by the patient-controlled analgesia (PCA) device, expressed in milligrams (mg) and milligrams per kilogram per day (mg/kg/d). The main objective of the study is to evaluate the reduction in the quantity of IV morphine required during the first 24 postoperative hours through the use of a locoregional anesthesia technique in patients undergoing throat and neck cancer surgery.