AuthorisedPhase III and phase IV (Integrated)Interventional

Echo-guided scalp blocks and incidence of postoperative pain in scheduled supratentorial intracranial surgery - ULTRASCALP

The ULTRASCALP study is investigating new ways to reduce pain after brain surgery (supratentorial intracranial surgery) where the scalp is opened. Doctors are using ultrasound to guide injections that numb specific nerves in the scalp before the operation. The main goal is to find out if this method helps patients experience less severe pain and reduces how much strong pain medication, like morphine, they need in the first six hours after surgery. Researchers will also be checking for other things like sickness, vomiting, and any lasting headaches. This study is for adults and aims to improve comfort for patients recovering from this type of surgery.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Centre Hospitalier Universitaire De Bordeaux

Enrolment target

230

Start

11 Jun 2025

supratentorial intracranial surgery with flap creation

What is this study about?

Imagine you're having brain surgery, which can sometimes lead to discomfort afterwards. This study, called ULTRASCALP, is looking into a new way to reduce that pain right from the start. Before your surgery, doctors are trying out a special technique where they use an ultrasound machine to help them precisely numb certain nerves in your scalp. This is a bit like getting a local anaesthetic at the dentist, but for your head.

The main aim of this research is to see if numbing these nerves before surgery using ultrasound guidance can make a real difference to how much pain you feel. They want to know if it helps people avoid severe pain and need less strong pain medication, such as morphine, in the first six hours after their operation. This could potentially make your recovery much more comfortable.

Along with checking pain levels, the researchers will also be keeping an eye on other important things. This includes whether you feel sick or vomit, how much pain medication you use in total, and if you develop any headaches that last for a few months after surgery. All of this information will help them understand the full picture of how well this new pain relief method works and if it can improve the experience for patients undergoing this type of brain surgery in the future.

Key takeaways

A study looking at new ways to manage pain after brain surgery.
Uses ultrasound-guided injections to numb scalp nerves before surgery.
Aims to reduce severe pain and the need for strong painkillers.
Monitors patients for pain, sickness, and lasting headaches.
Involves adults having specific brain surgery types.
Could help make recovery more comfortable for patients.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older, and male or female. The study is specifically for people who are scheduled to have a type of brain surgery called 'supratentorial intracranial surgery', which involves an opening in the skull and scalp.

There may be other reasons why someone might not be able to join, but the doctors overseeing the study will be able to explain all the details if you are interested. It's always a good idea to discuss your suitability with your medical team.

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 scheduled for 'supratentorial intracranial surgery'?
Is your surgery planned to include an opening of the scalp?
Are you able to follow study instructions and attend follow-up calls?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first thing is that you'll be having brain surgery as planned. Before your surgery, a doctor will use an ultrasound machine to guide injections that numb specific nerves in your scalp. During your surgery and in the first few hours afterwards, the medical team will closely monitor your pain levels and how much pain medication you need. They will use a simple pain scale, where you score your pain, and record how much strong pain relief you are given.

Nurses will continue to check your pain and any sickness or vomiting for up to 24 hours after your surgery. They will also record how much pain medication you use during this time. Finally, about three months after your surgery, a researcher will call you to ask if you've had any lasting headaches or if there have been any issues with the surgical wound. The total duration of your active involvement in the study is until that phone call three months later.

Potential risks and benefits

Taking part in this study might benefit you by potentially improving your pain relief after brain surgery, leading to a more comfortable recovery and possibly less need for strong painkillers. As with any medical procedure, there are potential risks, mainly related to the nerve block procedure itself, such as bruising or infection at the injection site, though these are usually minor. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What kind of surgery is this study about?

It's for a type of brain surgery called 'supratentorial intracranial surgery', which means surgery on the top part of the brain that involves opening the scalp.

What is the main goal of the study?

The main goal is to see if numbing nerves in the scalp before surgery, using ultrasound guidance, reduces pain and the need for strong painkillers like morphine after the operation.

What pain relief are they using?

They're using a mix of local anaesthetics like Xylocaine (with adrenaline) and Ropivacaine, similar to what a dentist might use, to numb the nerves.

Will I be monitored closely during the study?

Yes, your pain levels, medication use, and any sickness will be closely monitored by nurses and doctors for at least 24 hours after surgery.

What happens after the first day of my recovery?

About three months after your surgery, someone will call you to check on any lasting headaches or wound issues. This is the last part of the study monitoring.