RecruitingNAINTERVENTIONAL

Guiding Opioid Administration by Nociception Level Index (NOL) in Patients With Regional Anesthesia

This study is investigating a new device called the Nociception Level Index (NOL) which helps doctors understand how much pain a patient might be feeling during surgery, even when they are unconscious. The trial focuses on patients undergoing trauma or orthopaedic surgery who receive both general anaesthesia (putting them to sleep) and regional anaesthesia (numbing a specific body part). The main goal is to find out if using the NOL device to guide how much pain medication (opioids) is given during the operation can lead to less pain after surgery, reduce the total amount of opioids needed, and help patients recover better compared to standard care where doctors use their judgment for pain medication dosage. It's about finding the lowest possible dose of opioids while still keeping pain in check, to avoid side effects.

At a glance

Status

Recruiting

Phase

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

240

Start

12 May 2025

Estimated completion

01 Jan 2026

Nociceptive Pain Pain, Postoperative Analgesia, Postoperative Anesthesia Recovery Period Opioid Use

What is this study about?

When you have an operation, doctors use anaesthesia to make sure you don't feel pain. This often involves a combination of medicines to put you to sleep (general anaesthesia) and strong pain relievers called opioids. However, giving too many opioids can cause unwanted side effects like feeling sick or dizzy, and even make your recovery longer. Giving too few can mean you might still be experiencing some pain signals during surgery, which isn't ideal.

This study is looking at a new tool called the Nociception Level Index (NOL) which helps anaesthetists (doctors who give anaesthesia) work out the right amount of pain medicine to give during surgery. While you're unconscious, it's hard for doctors to know exactly how much pain relief you're getting. The NOL monitor gives them a better idea in real-time. By combining general anaesthesia with regional anaesthesia (which numbs a specific part of your body), doctors hope to reduce the overall need for strong opioid painkillers.

The main question this study wants to answer is whether using the NOL monitor during surgery, which helps guide how much pain relief is given, can lead to less pain for you when you wake up, and whether you'll need fewer strong painkillers both immediately after surgery and in the first 24 hours. The hope is that by fine-tuning the pain medication, patients will have a smoother recovery with fewer side effects.

Key takeaways

The study assesses a new monitor (NOL) to guide pain relief during surgery.
It's for people having trauma or orthopaedic surgery with general and regional anaesthesia.
Aims to reduce pain after surgery and the amount of strong pain medication (opioids) needed.
Hopes to improve recovery and lessen side effects from pain medications.
Compares guiding pain relief with NOL to standard doctor's judgment.

Who may be eligible?

This study is looking for adults aged 18 or older who are having planned surgery for injuries (trauma) or bone/joint problems (orthopaedic surgery). You must also be receiving both general anaesthesia (being put to sleep) and regional anaesthesia (numbing a specific body part) for your operation.

There are certain reasons why you might not be able to join. For example, if you have certain heart conditions like an irregular heartbeat, or if you're taking specific heart medications. Also if you have a history of misusing strong pain medication (opioids) or if you have certain nerve problems, you wouldn't be able to take part.

It's important that you would be able to describe your pain levels after surgery. If you need to go to intensive care straight after your operation, you also wouldn't be able to participate.

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 planned trauma or orthopaedic surgery?
Will you receive both general and regional anaesthesia for your operation?
Do you not have a history of misusing strong pain medications?
Do you not have certain serious heart conditions or nerve problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have your surgery as planned, receiving both general and regional anaesthesia. During your operation, one group of patients will have their pain medication guided by the NOL monitor, while the other group will receive standard care. Your anaesthetist will assess your pain levels and give you pain relief as needed. After your surgery, doctors will keep track of your pain levels and how much pain medication you use while you are recovering in the hospital, and for the first 24 hours after the operation. You will be asked about your comfort and recovery. The study doesn't involve any extra visits beyond your routine hospital stay.

Potential risks and benefits

Participating in this study might help doctors understand how to better manage pain during surgery, potentially leading to less pain and fewer side effects from pain medication for future patients. For you personally, there's a chance that using the NOL monitor could lead to a more tailored approach to your pain relief, which might reduce immediate pain or the overall amount of strong painkillers you need. However, like any medical procedure, there are no guarantees, and you might not experience a direct benefit. The risks involved are generally those associated with your surgery and anaesthesia, as the NOL monitor is just a monitoring device. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg Eppendorf
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is 'Nociception Level Index (NOL)'?

NOL is a special monitor that helps doctors understand how much pain a patient might be feeling during surgery, even when they are sleeping deeply under general anaesthesia.

What are opioids and why are doctors watching how much is used?

Opioids are strong pain medications. Doctors want to give just enough to control pain without giving too much, which can cause side effects like sickness or slow recovery.

What is the difference between general and regional anaesthesia?

General anaesthesia puts you completely to sleep for surgery. Regional anaesthesia numbs only a specific part of your body while you might stay awake or be lightly sedated.

Will I know if I'm in the group using the NOL monitor or the standard care group?

Because this study is about comparing approaches, you likely won't know which group you're in during the study. This helps ensure fair results.

Will my regular pain relief be affected if I join the study?

No, your doctors will always make sure you receive appropriate pain relief. This study aims to find the best way to do that.

How to find out more

Rainer Nitzschke, MD

r.nitzschke@uke.de +4915222815884 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.