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Study on Fentanyl Nasal Spray and Morphine for Managing Postoperative Pain in Patients After Surgery

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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 managing postoperative pain, which is the discomfort experienced after surgery. The study will compare the effectiveness of a Fentanyl Nasal Spray with a placebo nasal spray. Fentanyl is a strong pain reliever often used in medical settings. The trial will also compare these sprays to the standard method of pain relief using morphine, which is administered through an injection.

The purpose of the study is to assess how well the Fentanyl Nasal Spray works in reducing pain after surgery. Participants will use the nasal spray after undergoing orthopedic surgery, which involves procedures like knee joint replacement or fixing broken bones. The study will last up to 120 hours, during which the participants' pain levels will be monitored and compared to those using the placebo spray and morphine injections.

Throughout the study, participants will be asked to rate their pain at various times to help researchers understand the effectiveness of the treatments. The study aims to provide insights into whether the Fentanyl Nasal Spray can be a reliable option for managing pain after surgery, potentially offering a more convenient alternative to traditional methods like morphine injections.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, expected postoperative pain, and ability to use the administration device.

    Informed consent is required to participate in the study.

  2. Step 2

    Post-surgery recovery

    After orthopedic surgery, recovery takes place in a post-anesthesia care unit for at least 120 minutes.

    The study focuses on managing pain expected to require opioid treatment for at least 24 hours.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of either fentanyl nasal spray or a placebo nasal spray for pain management.

    The nasal spray is used intranasally, meaning it is sprayed into the nose.

  4. Step 4

    Pain management

    Pain intensity is monitored using a numeric rating scale at specific times: 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours after treatment begins.

    The effectiveness of the treatment is assessed by comparing pain ratings before and after treatment.

  5. Step 5

    Extended treatment

    If necessary, treatment may continue for up to 120 hours postoperatively.

    During this period, pain intensity is further monitored at additional time points: 36, 48, 60, 72, 84, 96, 108, and 120 hours.

  6. Step 6

    Alternative pain management

    If the nasal spray is not effective, morphine sulfate pentahydrate may be administered intravenously.

    This involves using a patient-controlled analgesia device, allowing self-administration of the medication.

  7. Step 7

    Study completion

    The study concludes when the treatment period ends or if the patient decides to terminate due to inadequate pain relief.

    Feedback on the usability and effectiveness of the treatment is collected from both patients and investigators.

Who can join the trial?

6 criteria

  • Must be a male or female who is **18 years or older**.
  • Must plan to stay in a **Post Anesthesia Care Unit (PACU)** or recovery room for at least **120 minutes** after having orthopedic surgery. This surgery should be done using **general anesthesia** and can include procedures like knee joint replacement or fixing certain types of bone fractures.
  • Must have an **American Society of Anesthesiology (ASA) physical status** of **I, II, or III**. This is a way to classify how healthy a person is before surgery, with I being the healthiest and III having more health issues.
  • Must be expected to have **moderate to severe pain** after surgery that will likely need treatment with strong pain medicine given through a vein for at least **24 hours**.
  • Must be able to use the device that controls how the medicine is given.
  • Must be willing and able to take part in all parts of the study, which includes signing a form to show they understand and agree to participate.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing postoperative pain after surgery cannot participate. Postoperative pain is the pain that occurs after a surgical procedure.
  • Individuals who are not undergoing orthopedic surgery are excluded. Orthopedic surgery involves operations on bones, joints, or muscles.
  • Participants who are not within the specified age range are excluded. The age range for this trial is not specified here, but it is important for eligibility.
  • Both male and female participants are eligible, so exclusion is not based on gender.
  • Individuals who are part of a vulnerable population are not included. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • Fentanyl Nasal Spray

    is a medication used in this trial to manage postoperative pain. It is administered through the nose using a special applicator. This form of fentanyl is designed to provide quick pain relief after surgery, especially for pain resulting from orthopedic procedures. The study aims to evaluate how effective this nasal spray is in reducing pain compared to other methods.

  • Morphine

    is another medication used in the trial for pain management. It is administered intravenously, meaning it is given directly into a vein. Patients can control the amount of morphine they receive through a patient-controlled analgesia device, allowing them to manage their pain levels after surgery. The trial compares the effectiveness of morphine with the fentanyl nasal spray in managing postoperative pain.

What is already known about the treatment

Fentanyl Nasal Spray – This medication is administered through the nose using a spray applicator. It is currently being studied in clinical trials for its effectiveness in managing postoperative pain, particularly following orthopedic surgery. Fentanyl is a well-known opioid used for pain relief, and its nasal spray form is being compared to a placebo and traditional intravenous morphine. The medication works by binding to opioid receptors in the brain, reducing the perception of pain. It is classified as an opioid analgesic.

Investigated diseases

Postoperative Pain – This condition occurs after surgical procedures and is characterized by discomfort and pain in the area where the surgery was performed. It is a common experience for patients following surgery, as the body responds to the trauma of the operation. The pain can vary in intensity and duration, often starting immediately after the procedure and gradually decreasing as the body heals. It is typically caused by the activation of pain receptors in response to tissue damage. The pain may be acute and sharp initially, but it can become more dull and throbbing as healing progresses. Managing this pain is crucial for patient comfort and recovery.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519625-38-00Protocol codeCWL15001Estimated enrolment160 patientsSponsor5med GmbH

sourced from the EU Clinical Trials Register and site verification

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