Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Efficacy of Intrathecal Morphine for Postoperative Analgesia with or without Suprainguinal Fascia Iliaca Block After Total Hip Arthroplasty: A Double-Blind Randomized Clinical Trial

This research is investigating the best ways to manage pain after a total hip replacement operation. Specifically, it's comparing a powerful painkiller given into the fluid around the spinal cord (called intrathecal morphine) with or without another pain-blocking injection given in the groin area. The main goal is to see how much pain people experience eight hours after surgery when moving their leg. Researchers will also track how much pain medicine is needed in total, pain levels at different times, and any side effects like sickness or dizziness. They'll also look at how quickly people recover and their overall experience with pain. This study is for adults having hip replacement surgery and aims to improve pain control and recovery for future patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Centre hospitalier universitaire de Liege

Enrolment target

114

Start

08 May 2024

Total hip arthroplasty under spinal anesthesia

What is this study about?

Imagine you're having a hip replacement. After such a big operation, managing your pain is really important for a good recovery. This study is looking into the best ways to do just that. It's comparing two main approaches to pain relief given during or immediately after the surgery. One involves a strong painkiller called morphine, which is given as a single injection into the fluid surrounding your spinal cord, often called a 'spinal'. The study is looking at whether this spinal morphine works best on its own, or if adding another type of pain-blocking injection, given in the upper thigh area, makes a difference.

The main thing researchers want to find out is how well these treatments control your pain when you gently move your leg, specifically eight hours after your surgery. They will ask you to rate your pain on a simple scale. But they're also interested in many other things. For example, they'll check how much pain relief you need in total over the first two days, how your pain levels change at different times, and if you experience any common side effects like feeling sick, dizzy, or constipated.

Ultimately, the goal of this study is to help doctors understand the most effective ways to manage pain after hip replacement surgery. By finding out which pain relief methods work best with the fewest side effects, they can improve the recovery experience for many people in the future, helping them get back on their feet more comfortably and quickly.

Key takeaways

This study evaluates different pain relief strategies after hip replacement surgery.
It compares a spinal painkiller (morphine) alone or with another pain-blocking injection.
The main goal is to find the most effective pain control 8 hours after surgery.
Researchers will also track total pain medication used, side effects, and recovery.
Participation involves careful pain monitoring and answering questionnaires over about a month.
The findings aim to improve future pain management for hip replacement patients.

Who may be eligible?

This study is looking for adults who are scheduled to have a total hip replacement operation. Both men and women are welcome to take part. There isn't a specific upper age limit, so as long as you're over 18 years old and fit enough for the surgery, you might be able to join.

To be eligible, your surgery would need to be performed using spinal anaesthesia. This is a common way to numb the lower part of your body for the operation. If your doctor plans to use a different type of anaesthetic, this study might not be suitable for you.

Your medical team will check other details from your health history to make sure the study is a safe and good fit for you. They will explain everything clearly before you make any decisions.

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 a total hip replacement operation?
Will your surgery be under spinal anaesthesia?
Are you generally well enough for the surgery?
Are you willing to have your pain and recovery closely monitored?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process will be quite similar to a standard hip replacement journey, but with a few extra steps related to the research. You will receive your pain medication as planned for your surgery, which might include an injection around your spine and potentially another pain-blocking injection in your upper thigh. What exactly you receive will be decided by chance, like flipping a coin, so neither you nor your doctor will know which combination you've had. This is to make sure the results are fair.

After your surgery, your pain levels will be carefully monitored. You'll be asked to rate your pain at specific times, especially when moving your leg gently eight hours after the operation. You'll also use a special pump if you need extra pain relief, which helps researchers track how much medication you use. Nurses will check for any side effects like feeling sick, dizzy, or problems with constipation or going to the toilet.

You'll fill out some questionnaires about your pain experience and how well you're recovering. These will happen at different times: on the first and second days after surgery, and again at seven days and thirty days after your operation. This helps the researchers understand your recovery over time. The total duration of your active participation, including these follow-up questionnaires, will be about a month after your surgery.

Potential risks and benefits

Taking part in this study may offer some potential benefits. You will receive very careful monitoring of your pain and recovery after surgery, which could lead to better pain management. The information gathered will also help improve pain relief for future patients having hip replacements. As with any medical procedure or medication, there are always potential risks, such as side effects from the pain relief medications—these could include feeling sick, dizzy, sleepy, constipated, or difficulty passing urine. Your medical team will explain all known risks to you in detail. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without it affecting your 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
Belgium

Common questions

What is a 'hip replacement'?

A hip replacement is an operation where a damaged hip joint is replaced with an artificial one, to help reduce pain and improve movement.

What does 'spinal anaesthesia' mean?

Spinal anaesthesia is an injection given into your back to numb the lower half of your body for an operation, so you don't feel pain during surgery.

Will I know which pain relief I'm getting?

No, because it's a 'double-blind' study, neither you nor your doctor will know which specific treatment you're receiving. This ensures the results are unbiased and fair.

What are the main things the doctors are looking for?

The main thing is how much pain you have when you gently move your leg 8 hours after surgery. They'll also check other pain levels, any side effects, and how well you recover overall.

Will I have to do extra visits after leaving the hospital?

You'll be asked to complete questionnaires at home, 7 days and 30 days after your surgery, to track your recovery. These can often be done over the phone or by mail.