AuthorisedTherapeutic use (Phase IV)Interventional

Hip Infiltration in Hip Arthroplasty (HiHa) study – a randomized controlled trial

The 'HiHa' study is looking at how to best manage pain after a total hip replacement operation. When you have a new hip, pain can be a big concern for the first few hours and days. This research is testing if giving a specific injection directly into the hip joint during surgery can help reduce how much extra pain medication people need in the first six hours after the operation. They will also look at overall pain levels, any side effects from pain medication, and how happy patients are with their pain relief. The aim is to find better ways to keep patients comfortable after this common surgery.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Reinier Haga Groep Orthopedisch Centrum B.V.

Enrolment target

120

Start

24 Apr 2025

Total Hip Arthroplasty / THA

What is this study about?

When you have a hip replacement (also called total hip arthroplasty), managing pain afterwards is very important. Doctors want to make sure you're as comfortable as possible so you can start getting back on your feet and recovering well. This study, called ‘HiHa’, is looking at a specific way to help with this pain.

Imagine a special injection that goes directly into your hip joint during the surgery itself. This study is testing if this injection, which contains either a saltwater solution (sodium chloride) or a pain-numbing medicine (ropivacaine hydrochloride), can reduce how much extra pain medication you need in the very first hours after your operation. They're particularly interested in the first six hours.

By carefully comparing these different approaches, the researchers hope to find the most effective and safest way to manage pain immediately after a hip replacement. This could lead to better pain relief and a smoother recovery for future patients undergoing this surgery.

Key takeaways

Study aims to improve pain relief after hip replacement surgery.
Compares two types of injections given during surgery for pain control.
Focuses on reducing the need for extra pain medicine in the first 6 hours.
Also measures overall pain, side effects, and patient satisfaction.
Open to adults having total hip replacement, all genders.

Who may be eligible?

This study is open to adults aged 18 and over. There is no upper age limit, so people of all adult ages can potentially take part. Both men and women are welcome to participate in this research.

The main requirement is that you are scheduled to have a total hip replacement (THA) surgery. Your doctor will be able to confirm if you meet all the specific health criteria for this study, as some medical conditions might mean it's not the right study for you. Always discuss your full health history with your doctor.

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 to have a total hip replacement operation?
Are you looking for ways to help manage pain after surgery?
Are you willing to have an injection into your hip joint during surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive one of two types of injections directly into your hip joint during your hip replacement surgery. One injection is a simple saltwater solution, and the other is a pain-numbing medicine. You wouldn't know which one you received, as this is a 'blinded' study to keep the results fair.

After your surgery, the research team would closely monitor how much pain medication you need, especially in the first six hours. They would also keep track of your pain levels using a simple scale, check for any side effects from your pain medication, and ask about your overall satisfaction with your pain relief. They'll also record things like any blood loss during surgery and if you needed a blood transfusion. This monitoring would continue during your hospital stay until you are discharged. There are no extra hospital visits required beyond your usual care.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of hip pain management, which could improve care for future patients. You might also experience improved pain control yourself, depending on which injection you receive. As with any medical procedure, there are potential risks, though these injections are commonly used. You might experience usual side effects associated with hip replacement surgery and pain medicines. All participants have the right to withdraw from the study at any time without affecting their 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
Netherlands

Common questions

What is a 'total hip arthroplasty'?

It's the medical term for a total hip replacement operation, where a damaged hip joint is replaced with an artificial one.

What are 'escape pain medications'?

These are extra pain medicines given to you when your usual pain relief isn't enough to keep you comfortable. They are also known as 'rescue' or 'as needed' pain relief.

What exactly will be injected into my hip?

You will receive either a simple saltwater solution (sodium chloride) or a local anaesthetic medicine called ropivacaine hydrochloride, which helps numb pain.

Will I know which injection I received?

No, it's a 'blinded' study, meaning neither you nor your care team will know which substance was injected. This helps ensure the results are unbiased.

Will taking part affect my standard care for hip replacement?

No, your standard care for hip replacement surgery will not change. This study is simply looking at an additional pain management technique.