CompletedPhase IIIInterventional

Pain relief after instrumented spinal surgery trial

Lower back surgery involving screws and rods can be very painful afterwards. Getting on top of pain quickly is important because it allows people to sit up, walk, and recover sooner, which reduces the chance of complications like blood clots or chest infections. Currently, NHS hospitals use different methods to treat this pain, but it is not clear which approach works best. The PRAISE clinical trial is comparing three standard options: usual care (strong painkillers given by mouth or drip), a single pain-relieving injection into the fluid around the spine, and a nerve block injection into the back muscles. Patients aged 16 and over having planned lower back surgery are randomly assigned to one of the three treatments. Researchers will measure pain levels during movement, recovery speed, and hospital stay to help improve future care across the NHS.

At a glance

Status

Completed

Phase

Phase III

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

456

Start

30 Sep 2024

Estimated completion

26 Sep 2025

Patients scheduled for elective, posterior lumbar-instrumented spinal surgery +/- decompression.

What is this study about?

Spinal surgery that uses metal rods or screws to stabilise the lower back is a common procedure in the NHS. While it can help relieve severe nerve pain or spinal damage, the surgery itself causes significant soreness afterwards. This pain can make it hard to move around, keep people in hospital longer, and slow down everyday recovery.

At present, doctors across the UK manage this pain in different ways. Most rely on standard strong painkillers such as morphine. Others offer an injection of pain relief directly into the fluid around the spinal cord, or a local anaesthetic injection to freeze the muscles in the back. Because all of these treatments are already used, doctors want clear evidence about which method offers the greatest relief with the fewest side effects.

The PRAISE trial has been set up to find that answer. By comparing all three treatments directly, researchers hope to see which option helps patients move around comfortably sooner after surgery. The results could help NHS hospitals choose the best, safest, and most cost-effective pain relief routine for everyone having this type of operation.

Key takeaways

The trial compares three common pain relief methods after lower back surgery.
Open to patients aged 16 and over having planned lower back surgery with metalwork.
You will be randomly assigned to standard painkillers, a spinal injection, or a nerve block.
Pain levels will be checked closely while resting and moving over your first three days.
Your routine surgical care remains the same, with no extra hospital visits required.

Who may be eligible?

You may be able to join this trial if you are aged 16 or over and are scheduled for planned (elective) lower back surgery that involves metal rods or screws. You must be able to understand the study details and give your own consent to take part. Interpreters are available if English is not your first language.

You will not be able to take part if you are having emergency surgery, if you are having surgery from the front of your body, or if you have already had metalwork fitted in your lower back in the past. It is also not suitable for people having very large operations across more than three spinal bones, or simple operations that do not require metal supports.

Finally, you cannot take part if you are pregnant, have an active infection or tumour near the lower back, have severe general health problems, or are allergic to strong painkillers or local anaesthetics.

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 16 or over.
I am scheduled for planned (not emergency) lower back surgery using screws or rods.
I have not had metalwork surgery in my lower back before.
I do not have allergies to morphine-type drugs or local anaesthetics.
I am not currently pregnant.

Answer every question to see your result.

What does participation involve?

If you agree to take part, you will be put into one of three treatment groups by chance (a computer decides randomly). You will receive either standard painkillers, a spinal injection, or a back muscle nerve block before or during your operation. You will not need any extra hospital visits just for the trial. While you recover on the ward, the research team will ask you to rate your pain—especially when turning or sitting up—at 6, 24, and 72 hours after surgery. They will also track how quickly you can walk, any side effects you experience, and how long you stay in hospital. Your final study check takes place during your normal follow-up clinic appointment 6 to 8 weeks after surgery.

Potential risks and benefits

There is no guarantee that taking part will give you better pain relief than standard care, but all patients will receive dedicated treatment for their pain. The information collected will help improve care for future surgical patients. Every pain treatment carries possible side effects. Standard strong painkillers can cause nausea, sleepiness, or constipation. Spinal injections and nerve blocks can occasionally cause itching, temporary numbness, or very rarely, an infection or reaction to the local anaesthetic. A senior anaesthetist will discuss all potential risks with you in detail before you decide. Taking part is completely voluntary, and you can withdraw at any time without your medical care being affected.

Locations (16)

Northern General Hospital
Approximate
Sheffield, England
Queens Medical Centre
Approximate
Nottingham, England
Ninewells Hospital
Approximate
Dundee, Scotland
Queen Elizabeth University Hospital
Approximate
Glasgow, Scotland
The Walton Centre NHS Foundation Trust
City only
Liverpool, England
Royal Preston Hospital
Unverified
Preston, England
Northumbria Healthcare NHS Foundation Trust
Unverified
North Shields, England
Hull University Teaching Hospitals NHS Trust
Unverified
Hull, England
South Tyneside and Sunderland NHS Foundation Trust
Unverified
Sunderland, England
Royal National Orthopaedic Hospital
Unverified
Stanmore, England
University Hospitals of Derby and Burton NHS Foundation Trust
Unverified
Derby, England
University Hospitals Coventry and Warwickshire NHS Trust
Unverified
Coventry, England

Common questions

Will I still receive pain relief if I join the trial?

Yes. Every participant in all three groups receives active, strong pain relief. If you still have pain after your operation, doctors and nurses will give you additional medicines to keep you comfortable.

Can I choose which pain relief method I receive?

No. To make the study fair and scientifically accurate, a computer programme assigns you to one of the three treatment groups at random.

Does taking part change my actual spine surgery?

No. Your surgeon will carry out the exact same spinal operation in the same way, regardless of whether you join the study.

Will I have to stay in hospital longer?

No. You will go home as soon as you and your surgical team feel you are safely recovered, just as you would normally.

What happens if I change my mind later?

You are free to leave the study at any point. You do not have to give a reason, and your medical team will continue to look after you as normal.

How to find out more

Marie Hyslop

m.c.hyslop@sheffield.ac.uk - Official trial record

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