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Study on Reducing Morphine Use After Throat and Neck Cancer Surgery Using Ropivacaine and Sodium Chloride for Patients Undergoing Cancer Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing surgery for throat and neck cancer. The study aims to evaluate a specific anesthesia technique called the superficial cervical plexus block. This technique is used to reduce the amount of morphine, a pain medication, needed after surgery. The trial involves the use of two medications: sodium chloride, which is a common salt solution used in medical settings, and ropivacaine, a local anesthetic that numbs a specific area of the body.

The purpose of the study is to see if this anesthesia technique can help decrease the need for morphine during the first 24 hours after surgery. Patients participating in the study will receive either the anesthesia technique or a placebo, and their morphine use will be monitored. The study will help determine if this method is effective in managing pain after cancer surgery.

Participants will be closely monitored throughout the study to ensure their safety and well-being. The trial will provide valuable information on whether this anesthesia technique can improve pain management for patients undergoing cancer surgery in the throat and neck area.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will have received oral information from a doctor and signed a written consent form. This confirms your understanding and agreement to participate in the study.

    You must be an adult patient undergoing ear, nose, and throat (ENT) cancer surgery with a procedure called cervicotomy. Additionally, you should be affiliated with a social security scheme or have Universal Medical Coverage (CMU).

  2. Step 2

    Pre-surgery preparation

    Before the surgery, you will be prepared for the procedure. This includes receiving a local anesthesia technique known as the superficial cervical plexus block.

    The anesthesia involves the use of two substances: sodium chloride and ropivacaine, both administered through an injection. This is intended to help reduce the amount of morphine needed after surgery.

  3. Step 3

    Surgery

    You will undergo throat and neck cancer surgery. The anesthesia provided aims to minimize discomfort during and after the procedure.

  4. Step 4

    Post-surgery care

    After the surgery, you will be monitored in the postoperative room. The main goal is to reduce the amount of intravenous (IV) morphine needed for pain management during the first 24 hours after surgery.

    The amount of morphine you consume will be measured, including both the morphine titrated in the postoperative room and the amount administered by the patient-controlled analgesia (PCA) device.

Who can join the trial?

5 criteria

  • Must be an adult patient.
  • Undergoing ENT cancer surgery with cervicotomy (surgery related to the ear, nose, and throat, involving an incision in the neck).
  • Must have received oral information from a doctor and signed a written consent form.
  • Must be affiliated with a social security scheme or have Universal Medical Coverage (CMU).
  • Both male and female patients can participate.

Who cannot join the trial?

4 criteria

  • Patients who have not undergone cancer surgery cannot participate. This means the study is only for those who have had surgery to remove cancer.
  • Patients who are not within the specified age range cannot participate. The study is for adults, so children and very elderly individuals are excluded.
  • Patients who are not able to understand or follow the study procedures cannot participate. This means that participants need to be able to understand what the study involves and follow instructions.
  • Patients who are part of a vulnerable population cannot participate. This includes groups of people who might be at higher risk of harm or exploitation.
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Investigated drugs

Morphine is a strong painkiller used to relieve severe pain. In this clinical trial, it is used to manage pain after throat and neck cancer surgery. The goal is to reduce the amount of morphine needed by using a special anesthesia technique. Morphine works by changing the way the brain and nervous system respond to pain, providing relief to patients during their recovery period.

What is already known about the treatment

Superficial Cervical Plexus Block – This medication is administered through a local anesthesia technique, specifically targeting the superficial cervical plexus, to help manage pain during and after cancer surgery in the throat and neck area. Currently, it is being evaluated in clinical trials to determine its effectiveness in reducing the need for intravenous morphine in the first 24 hours after surgery. The main therapeutic indication is to provide pain relief for patients undergoing oncological surgery in the neck and throat. The mechanism of action involves blocking nerve signals in the cervical plexus, which helps to reduce pain sensation in the targeted area. This technique falls under the pharmacological classification of local anesthetics.

Investigated diseases

Throat Cancer – Throat cancer refers to malignant tumors that develop in the throat, which includes the pharynx and larynx. It typically begins with abnormal cell growth in the lining of the throat, which can form a mass or tumor. As the disease progresses, these cancerous cells can invade nearby tissues and spread to other parts of the body. Symptoms often include a persistent sore throat, difficulty swallowing, and changes in the voice. The progression of throat cancer can lead to more severe symptoms, such as breathing difficulties and significant weight loss. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510942-15-00Protocol codeAPHP230866Estimated enrolment346 patientsSponsorAssistance Publique Hopitaux De Paris

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