Hemodynamic safety of isobaric levobupivacaine versus isobaric bupivacaine for subarachnoid anesthesia in patients over 65 years old undergoing hip fracture surgery
When an older adult breaks a hip, surgery is almost always needed to repair it. Anaesthetists often use a spinal injection to numb the lower body so the patient does not feel pain during the operation. This is often safer than general anaesthesia, but the numbing medicines can sometimes cause blood pressure or heart rate to drop. This trial compares two well-known, widely used numbing drugs: bupivacaine and levobupivacaine. Both are safe and already approved for surgery. Researchers want to find out which of the two is gentler on the heart and blood vessels in patients aged 65 and older. During surgery and for 48 hours afterwards, the medical team will closely monitor patients' blood pressure, oxygen levels, and heart function. The goal is to discover which medicine provides the smoothest and safest recovery.
At a glance
What is this study about?
A broken hip is a painful and serious injury that usually requires urgent surgery. To perform the operation safely, doctors often choose a spinal anaesthetic rather than putting the patient completely to sleep. With a spinal anaesthetic, medicine is injected into the fluid around the spinal nerves in the lower back. This completely numbs the lower body while keeping the patient comfortable and breathing naturally.
While spinal anaesthesia is very effective, it can cause a temporary drop in blood pressure and heart rate. For people aged 65 and older, who may already have high blood pressure or heart conditions, these sudden changes can place unwanted stress on the body. Doctors want to minimise these drops as much as possible to make surgery as gentle as it can be.
In this clinical trial, researchers are comparing two standard local anaesthetics: bupivacaine and levobupivacaine. Both drugs have been used for many years in hospitals. However, laboratory tests and earlier research suggest that levobupivacaine might be slightly gentler on the heart and circulation than standard bupivacaine.
By comparing the two medicines directly during hip fracture operations, doctors hope to gather clear evidence on how each one affects heart rhythm, blood flow, and oxygen levels. The findings will help anaesthetists make the safest choices for older patients having hip surgery in the future.
Key takeaways
- The trial compares two approved numbing medicines (bupivacaine and levobupivacaine) for hip fracture surgery.
- It aims to find out which drug is better at keeping blood pressure and heart rate stable in people aged 65 and over.
- Everything takes place during your normal hospital stay, with no extra visits required after you go home.
- Monitoring continues for 48 hours after surgery to track your recovery and check for any side effects.
- Joining is completely optional and will not delay your operation or affect your standard care.
Who may be eligible?
This trial is designed for people aged 65 and older who have been admitted to hospital with a broken hip and need surgery to repair or replace the joint. Both men and women are welcome to take part.
To be eligible, you must be in a suitable condition to receive a spinal anaesthetic. Your surgical and anaesthetic teams will assess your overall health and medical history to make sure this type of anaesthesia is appropriate for you.
You may not be eligible if you have certain medical conditions that make spinal injections unsafe. This can include severe blood-clotting disorders, severe infections near the injection site, or known allergies to local anaesthetic medicines. Your doctor will discuss all of these checks with you beforehand.
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.
- I am aged 65 or older.
- I have broken my hip and need surgery to fix it.
- My doctors have agreed that a spinal anaesthetic is suitable for me.
- I do not have a known allergy to local anaesthetic drugs.
- I do not have a medical condition that prevents me having an injection in my lower back.
What does participation involve?
Taking part in this study happens entirely during your standard hospital stay for hip surgery. Before your operation, you will be randomly assigned to receive either bupivacaine or levobupivacaine through a standard spinal injection in your lower back. During the operation, the anaesthetic team will use special monitors to closely measure your blood pressure, heart rate, and oxygen levels from moment to moment. Small blood samples may also be checked to see how well oxygen is circulating. After the surgery, the team will check in on you on the hospital ward for up to 48 hours to record your recovery and watch for any side effects. You will not need to attend any extra hospital visits once you are discharged home.
Potential risks and benefits
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Common questions
Will I be awake during the operation?
A spinal anaesthetic numbs you from the waist down so you feel no pain. Many people choose to have a mild sedative to help them feel relaxed or doze off lightly during the surgery.
Are these medicines experimental?
No. Both bupivacaine and levobupivacaine are fully approved, standard medicines that have been used safely in hospitals for years. The study is simply comparing them directly to see which is gentler on the heart.
Will joining the study delay my hip surgery?
No. Repairing a broken hip is an urgent procedure, and taking part will not delay your operation or interfere with your surgical schedule.
Does the spinal injection hurt?
Before the spinal anaesthetic is given, the doctor numbs the skin on your back with a tiny local injection. You may feel a quick sting or a feeling of pressure, but it is over very quickly.
Will I need to stay in the hospital longer?
No. The study monitoring only lasts for the first 48 hours after your operation, which is well within the normal recovery time for hip surgery.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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