The PRAISE Trial
Pain Relief After Instrumented Spinal surgEry trial.
About the study
Spinal surgery is common and very painful. Patients often need strong pain relief for three days or more after surgery. Good pain relief helps people get moving sooner and recover more quickly. Standard pain relief in the UK involves morphine through a drip and other painkillers such as paracetamol during surgery (multimodal analgesia). It is cheap, safe, quite effective for most patients and easy to give, but pain relief could be better for some people. There are two alternative methods for pain relief:
- Intrathecal opioid injection – injection of a morphine-like drug (opioid) into the spinal fluid at the time of surgery which provides pain relief for many hours after surgery
- Erector Spinae plane Block (ESB) – ultrasound guided pain ‘block’ of numbing, local anaesthetic into the muscles at the back of the spine at the end of an operation
We do not know which of these three methods is best. There are rare but possibly serious complications of the two alternative methods.
The PRAISE trial has been designed to find out which of these approaches is best for pain relief and helping patients to recover after lumbar spine surgery, and whether any one is better value for money.
We will be recruiting participants who are having planned lumber instrumented spinal surgery from NHS sites around the UK. Participants will be randomised to one of three groups:
- Usual care
- Usual care + Intrathecal Opioid
- Usual care + Erector Spinae plane Block
We will follow participants up during their time in hospital after surgery and 6-8 weeks later to find out about their pain after surgery and their recovery.
Central study staff
| Name | Role | |
|---|---|---|
| Matthew Wilson | Chief Investigator | m.j.wilson@sheffield.ac.uk |
| Lizzie Swaby | Trial Oversight | e.a.swaby@sheffield.ac.uk |
| Diana Papaioannou | Trial Oversight | d.papaioannou@sheffield.ac.uk |
| Sienna Hamer-Kiwacz | Trial Manager | s.a.hamer-kiwacz@sheffield.ac.uk |
| Liv Hawksworth | Research Assistant | o.hawksworth@sheffield.ac.uk |
| Joe Bretten | Research Assistant | j.bretten@sheffield.ac.uk |
| Naomi Roberts | Trial Support Officer | naomi.roberts@sheffield.ac.uk |
| Ines Rombach | Senior Statistician | i.rombach@sheffield.ac.uk |
| Stephen Maconi | Statistician | s.v.maconi@sheffield.ac.uk |
| Chris Turtle | Data Management | c.turtle@sheffield.ac.uk |
| Amanda Loban | Data Management | a.loban@sheffield.ac.uk |
Co-applicants
| Name | Role | Organisation |
|---|---|---|
| Mr Ashley Cole | Consultant Spinal Surgeon | Sheffield Children's NHS Foundation Trust |
| Professor Graeme Mcleod | Honorary Professor of Anaesthesia | The University of Dundee |
| Professor Alan Macfarlane | Consultant Anaesthetist | NHS Greater Glasgow and Clyde |
| Professor Shiva Tripathi | Consultant Anaesthetist | Lancashire Teaching Hospitals NHS Foundation Trust |
| Mr Martin Wilby | Consultant Neurosurgeon | The Walton Centre NHS Foundation Trust |
| Professor Daniel Hind | Professor of Evaluation | University of Sheffield |
| Dr Ines Rombach | Senior Statistician | University of Sheffield |
| Dr Anju Keetharuth | Senior Health Economist | University of Sheffield |
| Lizzie Swaby | Senior Study Manager | University of Sheffield |
| Bruce Martin | PPI representative |
Funder
This project is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme.
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust