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Study on the Effectiveness of Sphenopalatine Ganglion Block vs. Scalp Block in Patients Undergoing Craniotomy for Supratentorial Mass Using Levobupivacaine and Drug Combination

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 a type of brain surgery called a craniotomy for a condition known as a supratentorial mass, which refers to a growth located in the upper part of the brain. The study aims to compare two different methods of pain management during this surgery: the Sphenopalatine Ganglion Block and the Scalp Block. These methods involve numbing specific areas to help manage pain and other responses during the procedure. The main goal is to observe changes in the body's responses, such as heart rate and blood pressure, when a special headrest is used during surgery.

Participants in the study will receive one of the two pain management methods, and their responses will be monitored throughout the surgery. The study will also look at other factors, such as the level of pain relief, the need for additional pain medication like morphine, and any side effects that may occur. The medications used in this study include morphine hydrochloride, methylprednisolone, sodium chloride, propofol, lidocaine hydrochloride monohydrate, remifentanil, paracetamol, etoricoxib, cisatracurium besilate, and levobupivacaine.

The trial is designed to ensure that neither the participants nor the researchers know which pain management method is being used, a process known as a double-blind study. This helps to ensure that the results are unbiased. The study will monitor participants' recovery, including their level of comfort and satisfaction, and any side effects they may experience during their hospital stay. The trial is expected to run until 2026, with recruitment starting in 2024.

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, the patient will be informed about the trial's purpose and procedures. The trial aims to evaluate the effectiveness of two types of nerve blocks during brain surgery.

    The patient will undergo a craniotomy, which is a surgical procedure to remove a part of the skull to access the brain.

  2. Step 2

    Pre-surgery preparation

    Before the surgery, the patient will receive a series of medications to prepare for the procedure. These include morphine hydrochloride for pain relief, methylprednisolone to reduce inflammation, and sodium chloride as a solvent for other medications.

    The medications will be administered through an intravenous (IV) injection or infusion, which means they will be delivered directly into the bloodstream.

  3. Step 3

    Anesthesia and nerve block

    During the surgery, the patient will receive propofol for sedation and lidocaine hydrochloride monohydrate for local anesthesia. These will help ensure the patient is comfortable and pain-free during the procedure.

    A nerve block will be performed using either the sphenopalatine ganglion block or the scalp block. This is a technique to numb specific areas to prevent pain during surgery.

  4. Step 4

    Surgery

    The surgery involves accessing the brain to address the supratentorial mass. The patient's vital signs, such as heart rate and blood pressure, will be closely monitored throughout the procedure.

    Additional medications like remifentanil and cisatracurium besilate may be used to manage pain and muscle relaxation.

  5. Step 5

    Post-surgery recovery

    After the surgery, the patient will be moved to the post-anesthesia care unit (PACU) for monitoring. Pain management will continue with medications such as paracetamol and etoricoxib.

    The patient's recovery will be assessed using various measures, including pain scores and the level of alertness.

  6. Step 6

    Hospital stay and discharge

    The patient will remain in the hospital for observation and further recovery. The length of stay will depend on the patient's condition and recovery progress.

    Before discharge, the patient's overall recovery and satisfaction will be evaluated using specific questionnaires.

Who can join the trial?

5 criteria

  • Patients who are having a **craniotomy**. This is a type of surgery where doctors open the skull to access the brain.
  • The surgery is for a **supratentorial mass**, which means a growth or tumor located in the upper part of the brain.
  • Patients must be classified as **ASA 1-2**. This is a scale used to assess the physical health of patients before surgery, where ASA 1 means a healthy patient and ASA 2 means a patient with mild health issues.
  • All genders are eligible to participate.
  • Participants must be between 18 and 85 years old.

Who cannot join the trial?

4 criteria

  • Patients who are not undergoing a craniotomy for a supratentorial mass. A craniotomy is a surgical procedure where a part of the skull is removed to access the brain. A supratentorial mass is a growth located in the upper part of the brain.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a clinical trial group that is not included in this study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Sphenopalatine Ganglion Block

    is a procedure used in this trial to manage pain during and after surgery. It involves applying a local anesthetic to a specific nerve cluster located behind the nose, which can help reduce pain and improve comfort for patients undergoing certain types of brain surgery.

  • Scalp Block

    is another pain management technique used in the trial. This involves injecting a local anesthetic into the scalp to numb the area and reduce pain during and after brain surgery. It is used to help control pain and minimize the need for additional pain medications.

What is already known about the treatment

Sphenopalatine Ganglion Block – This medication is administered through an injection near the sphenopalatine ganglion, a group of nerves located behind the nose. It is currently being studied in clinical trials for its effectiveness in managing pain during craniotomy procedures for patients with supratentorial masses. The main therapeutic indication is to provide pain relief and stabilize hemodynamic changes during surgery. At the molecular level, it works by blocking nerve signals that transmit pain, thereby reducing discomfort. It is classified as a local anesthetic technique.

Investigated diseases

Supratentorial Mass – A supratentorial mass refers to an abnormal growth located in the upper part of the brain, above the tentorium cerebelli. This area includes the cerebral hemispheres, which are responsible for higher brain functions such as thought, memory, and voluntary movement. The mass can be a tumor, cyst, or other lesion, and its presence can lead to increased intracranial pressure. Symptoms may include headaches, seizures, or neurological deficits depending on the mass's size and location. As the mass grows, it can compress surrounding brain tissue, potentially affecting various bodily functions. The progression of symptoms often depends on the nature and growth rate of the mass.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512112-22-01Estimated enrolment88 patientsSponsorCHU De Liege

sourced from the EU Clinical Trials Register and site verification

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