Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Comparative analysis of the effectiveness and security of the blockade Erectus Spinae Plane Lumbar (ESP-L) versus the absence of locoregional block in hip surgery

This research study is comparing two ways to manage pain after hip or upper leg bone (femur) surgery. One group of patients will receive a special pain-relief injection in their back called an Erectus Spinae Plane Lumbar (ESP-L) block. The other group will have their pain managed without this specific injection. The main goal is to see if the ESP-L block helps reduce pain more effectively in the hours after surgery, using a pain scale. Researchers will also look at how much other pain medication people need, how easy the ESP-L injection is to perform, if there are any side effects, and how happy patients are with their pain relief. This study is for all adult patients having these types of surgeries.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Asociacion Gallega De Anestesiologia Reanimacion Y Dolor

Enrolment target

170

Start

27 May 2024

Hip fracture

What is this study about?

This study is focused on improving pain relief for patients undergoing hip or upper leg bone (femur) surgery. When you have an operation like this, managing pain afterwards is really important for your comfort and recovery. This study is looking at whether a specific type of pain-relief injection, called an ESP-L block, can make a difference.

An ESP-L block is an injection given in a specific area of the back. The idea is that it can help reduce pain in the hip area after surgery. In this study, some patients will receive this injection, while others will not have this specific block. The doctors will then compare how much pain both groups experience and how much other pain medication they need. They'll use a simple pain scale to measure this.

The main aim is to see if the ESP-L block is better at reducing pain in the first few hours after surgery. They also want to check if it's safe, how easy it is for doctors to give the injection, and if patients feel more satisfied with their pain relief. By comparing these two approaches, doctors hope to find the best ways to help patients recover more comfortably after hip surgery.

Key takeaways

This study compares different pain relief methods for hip surgery.
It aims to see if an ESP-L injection in the back helps reduce pain better.
You would be an adult patient having hip or upper leg bone surgery.
Pain levels and medication use will be carefully monitored after the operation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To take part in this study, you need to be an adult of 18 years or older. There is no upper age limit, meaning people of all adult ages can be considered.

Both men and women who are having surgery on their hip or the top part of their thigh bone (femur) might be suitable for this study.

The study will look at patients undergoing these specific types of operations to understand how the pain-relief methods work in this group.

Quick self-check

Are you 18 years old or older?
Are you having surgery on your hip or the top part of your thigh bone?
Are you a man or a woman?
Are you generally well enough to undergo standard medical care for your surgery?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first undergo your planned hip or upper thigh bone surgery. During this time, you would either receive the ESP-L pain-relief injection or have your pain managed without it, as decided by the study doctors. After your surgery, doctors would regularly ask you about your pain levels using a simple pain scale over a period of time. They would also keep track of any other pain medication you take. The study would also involve checking for any unexpected effects and asking about your overall satisfaction with your pain relief. The total duration of your participation would mainly focus on your immediate recovery period after surgery, likely a few days, during which your pain and medication use would be closely monitored.

Potential risks and benefits

Participating in this study might offer the potential benefit of better pain relief after hip surgery if you receive the ESP-L block, which could lead to a more comfortable recovery. As with any medical procedure, there are potential risks associated with the ESP-L injection, though these are generally considered small and will be explained by your doctor. You will be closely monitored for any side effects regardless of which group you are in. It's really important to remember that joining a study is always your choice, and you are free to withdraw at any time without affecting your medical care.

Locations (1)

—
Spain

Common questions

What is an ESP-L block?

It's a special pain-relief injection given in your back that aims to reduce pain in the hip area after surgery.

Why is this study being done?

Doctors want to find the best ways to manage pain after hip or upper leg surgery, specifically to see if the ESP-L block helps more than other pain relief methods.

Will I definitely get the injection if I join?

Not necessarily. The study compares getting the injection versus not getting it, so you might be in either group.

How will my pain be measured?

Doctors will use a simple pain scale (like a number from 0 to 10) to ask you about your pain levels after surgery.

What happens if I change my mind?

You are free to leave the study at any time, and it will not affect the medical care you receive.