RecruitingEARLY_PHASE1INTERVENTIONAL

Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery

This early study is looking into spinal anaesthesia for specific lower back operations. Rather than putting you completely to sleep, spinal anaesthesia numbs the lower part of your body. We're directly comparing two types of spinal anaesthesia – one using a common drug called bupivacaine, and another using a newer drug called ropivacaine – against traditional general anaesthesia where you are fully asleep. The main goal of this early research is to see if it's practical to carry out a larger study in the future. We're checking how many people might be suitable, willing to join, and if they find spinal anaesthesia acceptable. We're also gathering early information to help us plan for a bigger study later on.

At a glance

Status

Recruiting

Phase

EARLY_PHASE1

Sponsor

Fraser Health

Enrolment target

Start

27 Aug 2024

Estimated completion

31 Dec 2025

Anesthesia, Spinal Neurosurgery Ropivacaine Bupivacaine

What is this study about?

Imagine you're having an operation on your lower back. Usually, you might be given a general anaesthetic, which means you're completely asleep for the whole procedure. However, doctors are also very interested in another option called spinal anaesthesia. This is when medicine is injected near your spinal cord to numb the lower half of your body, so you're awake but don't feel any pain during the operation.

This particular study is a very early step, often called a 'pilot' study. Its main purpose isn't to get final results, but to figure out if it's possible and practical to do a bigger, more detailed study later on. We want to see if patients, surgeons, anaesthetists, and nurses are comfortable with using spinal anaesthesia for certain lower back surgeries. We're specifically looking at a newer anaesthetic drug called ropivacaine, comparing it to another common anaesthetic, bupivacaine, and also to general anaesthesia.

The information we gather from this study will help us understand things like how many people might be suitable and willing to take part in such a study, how many might leave the study early, and if everyone involved finds the process acceptable. This will allow us to design a much larger, more comprehensive study in the future to properly compare these different anaesthesia options for lower back surgery.

Key takeaways

This is an early study comparing different anaesthesia for lower back surgery.
It's checking if spinal anaesthesia with a new drug (ropivacaine) is practical and acceptable.
You'd be randomly assigned to general anaesthesia, or spinal anaesthesia with bupivacaine or ropivacaine.
Your feedback and experience will help plan future, larger studies.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult patients, aged 19 to 80, who are having a specific type of planned (non-emergency) surgery on their lower back. This would be for one or two levels of the spine between L2 and S1, done through a cut in the back, and is expected to last no longer than two hours. You also need to be generally in good health (rated as ASA Physical Status Class 1 to 3) and be able to understand information and answer questions in English, as well as stay still during surgery.

However, you wouldn't be able to join if you've had a bad reaction to certain anaesthetics before, or if you have certain health conditions that make spinal anaesthesia unsafe. These include problems with blood clotting (or if you're taking blood thinners), severe heart valve problems, infections, high pressure in your head, or an infection where the injection would go in your back. You also can't participate if your surgery is expected to last over two hours, is an emergency, or if you've had surgery on the same part of your back before. Other reasons not to participate include having other health problems that mean you must have general anaesthesia, if you can't move your legs before the operation, or if you have a very high Body Mass Index (BMI over 35), or severe narrowing in many parts of your spine.

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 aged between 19 and 80 years old?
Are you having planned lower back surgery (L2-S1, via the back) that's expected to be 2 hours or less?
Are you generally healthy and able to understand English?
Do you have any severe allergies to anaesthetic drugs or blood clotting problems?
Have you had surgery on the same part of your back before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of three groups, much like flipping a coin. You wouldn't get to choose which group you are in. One group will receive general anaesthesia, meaning you will be completely asleep during your surgery. The other two groups will receive spinal anaesthesia, where medicine is used to numb the lower half of your body while you remain awake. One of these spinal anaesthesia groups will use ropivacaine and the other bupivacaine.

Before your surgery, doctors and nurses will assess you to make sure you're suitable for the study and to gather some basic information. During the surgery, the anaesthesia will be given as planned for your group. After your surgery, the medical team will keep a close eye on your recovery, just as they normally would. They will also ask you questions to understand your experience and gather information about how you are doing. The total duration of your involvement in the study will mostly revolve around your surgery and immediate recovery period in the hospital.

Potential risks and benefits

Taking part in any research study has potential upsides and downsides. One potential benefit here is that you might receive spinal anaesthesia with a newer drug, ropivacaine, which researchers are hoping could offer advantages, although this is still being explored. Your participation will also help doctors learn more about the best anaesthesia options for lower back surgery, which could benefit many patients in the future. As for risks, any medical procedure involving anaesthesia carries some risks, which your anaesthetist will discuss with you. These are generally the same risks that you would have if you were not in the study, for any anaesthesia type. The specific risks related to spinal anaesthesia (like headache or nerve issues) will be explained. Remember, your safety is always the top priority, and you are free to change your mind and leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Royal Columbian Hospital
Verified postcode
New Westminster, Canada· Not yet recruiting
Eagle Ridge Hospital
Verified postcode
Port Moody, Canada· Recruiting

Common questions

What is spinal anaesthesia?

Spinal anaesthesia is when medicine is injected into your lower back to numb your lower body, so you don't feel pain during surgery, but you remain awake.

Will I be awake during surgery if I have spinal anaesthesia?

Yes, if you're in one of the spinal anaesthesia groups, you will be awake during your surgery, but you won't feel any pain in the numb area.

What is the difference between ropivacaine and bupivacaine?

Ropivacaine and bupivacaine are both types of local anaesthetic drugs used for spinal anaesthesia. This study is exploring if ropivacaine offers different benefits for patients undergoing back surgery.

How long will I be in the study?

Your involvement in the study will primarily be around the time of your surgery and immediate recovery in the hospital.

Can I choose which type of anaesthesia I get?

No, if you join the study, you'll be randomly assigned to one of the three anaesthesia groups (general, spinal with bupivacaine, or spinal with ropivacaine) by chance, like drawing lots.

How to find out more

Michelle Mozel, MSc.

michelle.mozel@fraserhealth.ca 604-520-4253 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.