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Comparison of Two Ketamine Administration Methods for Perioperative Pain Relief in Patients Undergoing Spinal Fusion 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

The study involves patients who are having spinal fusion surgery, a procedure that joins two or more bones of the spine to make them more stable. During the operation, a medication called ketamine is given through a vein to help control pain.

The purpose is to find out which of three ways of giving the drug leads to the lowest amount of morphine needed after the operation. Morphine is a strong pain medicine that is often used after surgery.

Participants will be randomly placed into one of three groups, each receiving ketamine in a different style, including a method that uses a TCI model to keep drug levels steady. After the surgery, patients will stay in the PACU, where their pain relief and any additional pain medicines are recorded, and blood samples will be taken to see how the drug moves through the body. The study follows patients through their hospital stay to compare the total amount of morphine used.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and preparation

    After joining the study, you will be assigned to one of three groups that differ only in the way ketamine is given during surgery.

    The study team will explain the assigned method and prepare the medication for the operation.

  2. Step 2

    Intravenous ketamine administration

    During the spinal fusion operation, you will receive an intravenous (through a vein) dose of ketamine at a total amount of 400 mg per kilogram of body weight.

    The medication is supplied as a 50 mg/ml solution for injection and will be given according to the specific style assigned to your group (continuous infusion, bolus doses, or a target‑controlled infusion model).

    The administration lasts for the duration of the surgery.

  3. Step 3

    Post‑anesthesia care unit monitoring

    After surgery you will be moved to the post‑anesthesia care unit (pacu) where your pain level and the amount of morphine you need will be recorded.

    The primary aim is to compare how much morphine each group requires during this recovery period.

  4. Step 4

    Rescue analgesia if needed

    If pain is not controlled with the planned medication, additional pain relief (rescue analgesia) may be given.

    The use of any rescue medication will be documented as part of the study.

  5. Step 5

    Hospital stay pain management

    Throughout your hospital stay, the total amount of morphine you receive will continue to be measured.

    This data helps determine whether the different ketamine administration styles affect overall opioid use.

  6. Step 6

    Blood sampling for ketamine levels

    Blood samples will be taken at scheduled times to measure the concentration of ketamine in your plasma.

    These samples provide pharmacokinetic information and are collected without affecting your care.

  7. Step 7

    Study completion

    Once all pain medication usage and blood sample data have been collected, your participation in the trial will end.

    The study team will compile the information to compare the three administration methods.

Who can join the trial?

5 criteria

  • You are between 18 and 70 years old.
  • You are male or female.
  • You are scheduled for a planned (elective) spinal surgery that joins one level of the spine (one level spinal fusion surgery).
  • Your overall health is rated as ASA I‑III, meaning you are healthy or have only mild to moderate medical problems.
  • You can understand the study information and agree to take part (capable of giving informed consent).

Who cannot join the trial?

6 criteria

  • Being younger than 18 years old.
  • Having a body mass index (BMI) greater than 30, which means a level of obesity.
  • Being pregnant or breastfeeding.
  • Having an allergy (hypersensitivity) to ketamine or a medical reason that makes using ketamine unsafe (contraindication).
  • Having had multiple‑level spinal fusion surgery, meaning surgery that fused several sections of the spine.
  • Having had anterior spinal fusion surgery, which is a fusion performed from the front side of the spine.
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Investigated drugs

Ketamine is a medication given through an IV line during surgery. In this study it is used to help control pain after spinal fusion operations. By providing pain relief directly, it may lower the amount of morphine patients need in the recovery room and during their hospital stay, which can reduce side‑effects from opioids. The trial compares three different ways of giving the same ketamine medicine: a single dose given at the start of surgery (Style A), a continuous drip that runs throughout the operation (Style B), and a computer‑controlled infusion that adjusts the dose automatically (Style C). Each method is tested to see which one best reduces the need for additional pain medicines after the procedure.

What is already known about the treatment

Ketalar 50 mg/ml solution injectable - It is a sterile solution for injection that is given intravenously, usually as a short infusion. Ketamine is an approved anesthetic and is widely documented in medical literature for use during surgery and for pain control. It is mainly used to induce anesthesia and to provide analgesia around the time of an operation. It works by blocking NMDA receptors in the brain, which reduces pain signals and creates a mild dissociative state, and it is classified as a dissociative anesthetic (ATC code N01AX03).

Investigated diseases

Spinal fusion surgery - It is a procedure that joins two or more vertebrae to create a single, solid bone segment, aiming to stabilize the spine. After the operation, the bone graft gradually turns into solid bone over several weeks to months, making the fused area rigid. This loss of movement can reduce pain caused by unstable or degenerated spinal joints. Over time, the surrounding segments may experience increased stress, which can lead to additional changes in those areas. The fused segment remains stable for the rest of the person’s life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-527990-12-00Protocol codeKET-COMPASS TRIALEstimated enrolment27 patientsSponsorCHU Saint Pierre

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