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Study on Reducing Postoperative Pain in Brain Surgery Patients Using Ropivacaine, Lidocaine, and Epinephrine

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 supratentorial intracranial surgery, which is a type of brain surgery involving the upper part of the brain. The study aims to explore the effectiveness of a technique called echo-guided scalp blocks in reducing severe pain after surgery. This technique involves using ultrasound to guide the administration of pain relief medications directly to the scalp area to help manage pain after the operation.

The medications being studied include XYLOCAINE (which contains epinephrine bitartrate and lidocaine hydrochloride), ROPIVACAINE KABI (containing ropivacaine hydrochloride), MORPHINE, and PARACETAMOL B. BRAUN (containing paracetamol). These medications are used to manage pain and are administered in different forms, such as injections or infusions. Some patients may receive a placebo as part of the study to compare the effects of the actual medications.

The study will monitor patients for pain levels and the need for additional pain relief, such as morphine, in the hours and days following surgery. It will also track any side effects like nausea or vomiting and check for any signs of infection at the surgical site. The study will last until 2027, with patient recruitment starting in 2025. The goal is to determine if the echo-guided scalp blocks can effectively reduce the need for strong pain medications and improve recovery after brain surgery.

The research process

The trial runs in 6 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, a consent form is signed. This form confirms understanding and agreement to participate in the research. It is important to ensure that all questions are answered before signing.

  2. Step 2

    Pre-surgery preparation

    Before the surgery, an echo-guided scalp block is performed. This involves using ultrasound to guide the administration of local anesthetics to specific nerves in the scalp. The medications used include epinephrine bitartrate and lidocaine hydrochloride, administered as a solution for injection.

  3. Step 3

    Surgery

    During the surgery, the medical team monitors vital signs and administers necessary medications. The focus is on ensuring comfort and safety throughout the procedure.

  4. Step 4

    Immediate post-surgery care

    After surgery, pain levels are closely monitored. If severe pain occurs, morphine may be administered at a dosage greater than 0.05 mg per kg of body weight. Pain is assessed using a numerical scale, and any score above 4 is considered severe.

    The amount of morphine used is recorded hourly for up to 6 hours after waking from anesthesia.

  5. Step 5

    Post-surgery monitoring

    Pain levels are checked every hour for the first 6 hours after surgery and again at 24 hours post-surgery. Paracetamol may be administered as a solution for infusion to help manage pain.

    The occurrence of nausea and vomiting is also monitored at 6 and 24 hours after surgery. If needed, anti-nausea medication is provided.

  6. Step 6

    Follow-up

    Three months after surgery, a follow-up is conducted via telephone to check for any persistent headaches or surgical site infections. Pain levels and the need for additional pain medication are assessed.

Who can join the trial?

4 criteria

  • Must be over 18 years old.
  • Must be a patient admitted to the neurosurgical unit for a specific type of brain surgery called intracranial supratentorial surgery with a flap.
  • Must be a person who is affiliated with or benefiting from a social security scheme.
  • Must provide free, informed, and written consent signed by both the participant and the investigating doctor. This must be done no later than the day of joining the study and before any study-related examinations.

Who cannot join the trial?

3 criteria

  • Patients who have had supratentorial intracranial surgery with flap creation cannot participate. This means surgery on the upper part of the brain where a piece of the skull is temporarily removed.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who belong to vulnerable populations are not eligible. Vulnerable populations include groups that may need special protection or care.
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Investigated drugs

Echo-guided scalp blocks are a type of pain management technique used during and after surgery. In this trial, they are used to help reduce severe pain following brain surgery. The procedure involves using ultrasound (or "echo") technology to guide the precise delivery of anesthetic medication to specific nerves in the scalp. This helps to block pain signals from reaching the brain, making the recovery period more comfortable for patients.

What is already known about the treatment

Echo-guided scalp blocks – This technique involves the administration of local anesthetics to specific nerves in the scalp using ultrasound guidance, primarily to manage pain after brain surgeries that involve opening the skull. Currently, this method is being studied for its effectiveness in reducing severe pain following such surgeries, as highlighted in medical research. The main therapeutic use is to provide pain relief after brain surgery, specifically when the surgery involves creating a flap in the skull. The mechanism of action involves blocking nerve signals that transmit pain from the scalp to the brain. This technique falls under the pharmacological classification of local anesthesia.

Investigated diseases

Supratentorial Intracranial Surgery with Flap Creation – This procedure involves surgical intervention in the brain above the tentorium cerebelli, which is a membrane separating the cerebrum from the cerebellum. During the surgery, a flap of bone is temporarily removed to access the brain tissue. The progression of this condition involves the initial surgical intervention, followed by a recovery period where the bone flap is replaced and the scalp is closed. Postoperative recovery includes monitoring for complications such as pain, infection, and neurological changes. The healing process involves the gradual resolution of surgical trauma and restoration of normal brain function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-520320-28-00Protocol codeCHUBX 2023/42Estimated enrolment230 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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