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Study on the Effect of Esketamine and Sodium Chloride on Post-Craniotomy Headache in Patients with Drug-Resistant Temporal Lobe Epilepsy

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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 studying the effects of a medication called Esketamine on pain experienced after a type of brain surgery known as a craniotomy. The surgery is performed on patients with a condition called drug-resistant temporal lobe epilepsy, which means that their seizures do not respond to typical medications. The study aims to see if adding Esketamine to the usual pain management plan, which includes medications like acetaminophen and opioids, can reduce the need for opioids after surgery.

Participants in the study will receive either Esketamine or a placebo, both given through an intravenous infusion, which means the medication is delivered directly into the bloodstream. Another substance used in the study is Sodium Chloride, commonly known as salt water, which is often used in medical settings as a fluid for injections. The study will monitor the total amount of opioids used by patients in the first week after their surgery to see if Esketamine makes a difference.

In addition to tracking opioid use, the study will also look at other factors such as how long patients stay in the hospital, their quality of life, and any side effects they experience. Pain levels will be assessed using standard pain rating scales. The goal is to find out if Esketamine can help manage pain more effectively and improve recovery after surgery for those with drug-resistant temporal lobe epilepsy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be asked to provide your signed informed consent. This confirms your understanding and agreement to participate in the study.

  2. Step 2

    Pre-surgery preparation

    Before your surgery, you will undergo a series of assessments to ensure you meet the criteria for participation. This includes confirming your age is over 18 and that you are scheduled for elective surgery for drug-resistant temporal lobe epilepsy.

  3. Step 3

    Surgery and medication administration

    During your surgery, you will receive an intravenous infusion of esketamine or a placebo, along with a standard pain management approach that includes acetaminophen and opioids. The specific dosage and frequency will be determined by the medical team based on your individual needs.

  4. Step 4

    Postoperative monitoring

    After your surgery, your total opioid consumption will be measured at 24, 48, 72, and 96 hours, and again on the 7th day post-surgery. This helps assess the effectiveness of the pain management strategy.

  5. Step 5

    Secondary assessments

    Throughout the first 7 days after your surgery, additional assessments will be conducted. These include evaluating your length of hospital stay, quality of life through a questionnaire, psychological parameters, any adverse events, and your pain levels using specific scales.

Who can join the trial?

6 criteria

  • Must be older than 18 years.
  • Scheduled for planned surgery to remove part of the brain to treat drug-resistant temporal lobe epilepsy. This means epilepsy that does not get better with medication.
  • Has drug-resistant epilepsy, which means:
    • Long-term, focused seizures that do not stop with medication.
    • Cannot become seizure-free with current epilepsy medication.
    • No other medication options available due to side effects.
    • Must have signed a form agreeing to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who have a **serious allergy** to any of the study medications cannot participate. A serious allergy is a strong reaction that can cause symptoms like difficulty breathing or a rash.
  • Patients who are **pregnant** or **breastfeeding** are not allowed to join the study.
  • Patients with a history of **substance abuse** or **addiction** to drugs or alcohol cannot take part. Substance abuse means using drugs or alcohol in a way that is harmful.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Patients with **severe liver or kidney disease** cannot participate. These are conditions where the liver or kidneys do not work properly.
  • Patients with **uncontrolled high blood pressure** are excluded. This means their blood pressure is too high and not managed by medication or lifestyle changes.
  • Patients with a history of **severe mental health disorders** such as schizophrenia or bipolar disorder cannot join. These are serious conditions that affect mood and thinking.
  • Patients who have had a **stroke** or **heart attack** in the past 6 months are not eligible. A stroke is when blood flow to the brain is blocked, and a heart attack is when blood flow to the heart is blocked.
  • Patients with **active infections** that require treatment with antibiotics are excluded. An active infection is when germs are causing illness in the body.
  • Patients who are unable to follow the study procedures or attend follow-up visits cannot participate.
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Investigated drugs

  • S-ketamine

    is a medication used in this trial to help manage pain after surgery. It is given through an IV, which means it goes directly into your bloodstream. In this study, it is being tested to see if it can reduce the amount of other pain medications, like opioids, that patients need after having brain surgery. S-ketamine is known for its ability to relieve pain and is being added to a combination of other pain treatments to see if it can improve pain control.

  • Acetaminophen

    is a common pain reliever that is often used to reduce fever and relieve mild to moderate pain. In this trial, it is part of a combination of treatments given to patients to help manage pain after brain surgery. Acetaminophen is usually taken by mouth, but it can also be given through an IV. It works by blocking certain chemicals in the brain that cause pain and fever.

  • Opioids

    are a group of strong pain-relieving medications that are often used to treat severe pain, such as the kind that can occur after surgery. In this study, opioids are part of the standard pain management approach. They work by binding to specific receptors in the brain and spinal cord to reduce the perception of pain. The trial is looking at whether adding s-ketamine can help reduce the amount of opioids needed after surgery.

What is already known about the treatment

S-ketamine – S-ketamine is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials to assess its effectiveness in reducing pain after brain surgery, specifically for patients with drug-resistant temporal lobe epilepsy. The main therapeutic use being investigated is its ability to decrease the need for opioids, which are strong painkillers, after surgery. At the molecular level, S-ketamine works by blocking certain receptors in the brain that are involved in pain perception, which can help reduce pain. It is classified pharmacologically as an anesthetic and is known for its pain-relieving properties.

Investigated diseases

Post-craniotomy headache – This condition occurs after a surgical procedure known as a craniotomy, where a part of the skull is removed to access the brain. The headache typically arises due to the surgical intervention and can vary in intensity and duration. It may be influenced by factors such as the size and location of the craniotomy, as well as individual patient characteristics. The pain is often described as a throbbing or pressure-like sensation around the surgical site. It can be accompanied by other symptoms such as nausea or sensitivity to light and sound. The headache usually progresses over the days following surgery and may gradually decrease in intensity as the healing process continues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514020-16-00Estimated enrolment62 patientsSponsorAcademisch Ziekenhuis Maastricht

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