Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized, parallel group, multi-center study of a fentanyl nasal spray compared with placebo nasal spray for postoperative pain management and prolonged open treatment over up to 120 hours postoperatively compared with intravenous patient-controlled analgesia using morphine

This study is looking at new ways to manage pain after surgery. Researchers are comparing a nasal spray that contains a medicine called fentanyl with the standard treatment, which is morphine given through a drip that patients control themselves. The main goal is to find out if the fentanyl nasal spray is as good as, or better than, morphine at relieving pain in the first 24 hours after an operation. They also want to see how long the pain relief lasts for up to five days and how easy the nasal spray is for patients to use. This is a large, important study (Phase III) that helps decide if a new treatment should become more widely available to patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, 5med GmbH

Enrolment target

160

Start

28 Jan 2025

Postoperative pain relief

What is this study about?

When you have surgery, managing pain afterwards is really important. Strong painkillers are used to help you feel comfortable while you recover. This study is exploring a new way to give pain relief: a nasal spray containing a medicine called fentanyl. Fentanyl is a strong painkiller that is already used in hospitals.

Currently, many patients use a method called 'patient-controlled analgesia' (PCA) where they can press a button to give themselves small doses of morphine through a drip when they need it. This study wants to see if the fentanyl nasal spray could be a good alternative to this traditional method. They're comparing it directly to morphine PCA to understand how well it works and if it's easier or more convenient for patients.

This type of study is called a 'Phase III' trial. These are the final big studies done before a new medicine or treatment can be approved for wider use. By comparing the new nasal spray to a standard treatment, the researchers hope to gather strong evidence that will help doctors and patients make informed choices about pain relief after surgery in the future.

Key takeaways

This study compares a fentanyl nasal spray for pain after surgery with standard morphine treatment.
It aims to see if the nasal spray works as well as, or better than, morphine pain control.
The study also checks how easy the nasal spray is to use for patients and healthcare staff.
This is a Phase III trial, a critical step before a new treatment can be approved.
You would be observed for up to five days after surgery, with regular pain checks.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part.

Both men and women are welcome to participate in this research. The study aims to gather information from a broad range of patients to ensure the results are widely applicable.

Specific details about your health condition, other medicines you might be taking, or the type of surgery you are having would also be important. These will be checked by the study team to make sure it's safe and appropriate for you to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having surgery that will require pain relief afterwards?
Are you comfortable with the idea of possibly receiving a nasal spray, a dummy nasal spray, or standard morphine for pain?
Can you understand and answer questions about your pain levels?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of three groups: either the fentanyl nasal spray, a 'dummy' nasal spray (placebo) that looks and feels the same but contains no medicine, or the standard morphine pain relief through a drip. The study treatment would start after your surgery as soon as you need pain relief.

For up to five days (120 hours) after surgery, the study team would regularly check on your pain levels using a simple number scale. You would be asked how much pain you feel at specific times, for example, 1 hour, 2 hours, 3 hours, and up to 24 hours after starting the treatment, and then at longer intervals for the rest of the five days. The team will be looking at how long it takes for a treatment to stop working well enough, or if you need to stop it for any reason.

During your time in the study, the team would also ask you about how easy it was to use your pain relief and how well you felt it worked. Nurses and physiotherapists might also give their feedback on ease of care. The overall duration you'd be actively involved in the study's assessments would be up to 120 hours (five days) after your surgery.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from careful monitoring of your pain and overall care. If you receive the fentanyl nasal spray, it could offer a new way to manage your pain effectively. However, like all medicines, fentanyl and morphine can have side effects, and some patients might find the treatment doesn't relieve their pain as well as they hoped. You would be fully informed about known side effects before consenting, and the study team would closely monitor you for any concerns. Most importantly, you are always free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Bulgaria

Common questions

What is a Phase III study?

A Phase III study is a large, important trial that compares a new treatment with a standard one to see if it's safe and effective before it can be widely available.

Will I know which treatment I'm getting?

No, in this type of study, you won't know if you're getting the active nasal spray or the placebo, or if you're in the morphine group. This is to ensure fair and unbiased results.

What if my pain isn't well controlled?

If your pain isn't managed well by the study treatment, the team will ensure you receive appropriate alternative pain relief, and you might leave the study early.

How long will I be involved?

You will be actively involved in the study, with pain assessments and monitoring, for up to 120 hours (five days) starting right after your surgery.

What is a 'nasal spray placebo'?

A nasal spray placebo is a 'dummy' spray that looks and feels exactly like the fentanyl nasal spray but doesn't contain any active medicine. It helps researchers compare the real drug's effects.