The PRAISE Trial

Pain Relief After Instrumented Spinal surgEry trial.

On

91Ö±²¥ 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 Email
Matthew Wilson Chief Investigator m.j.wilson@sheffield.ac.uk
Lizzie Swaby Trial Oversight e.a.swaby@sheffield.ac.uk
Daniel Hind Trial Oversight d.hind@sheffield.ac.uk
Sienna Hamer-Kiwacz Trial Manager s.a.hamer-kiwacz@sheffield.ac.uk
Liv Hawksworth Research Assistant o.hawksworth@sheffield.ac.uk
Naomi Roberts Trial Support Officer naomi.roberts@sheffield.ac.uk
Ines Rombach Senior Statistician i.rombach@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 91Ö±²¥ 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 91Ö±²¥
Dr Ines Rombach Senior Statistician University of 91Ö±²¥
Dr Anju Keetharuth Senior Health Economist University of 91Ö±²¥
Lizzie Swaby Senior Study Manager University of 91Ö±²¥
Bruce Martin PPI representative  

Funder

This project is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme.


91Ö±²¥ Teaching Hospitals NHS Foundation Trust

Centres of excellence

The University's cross-faculty research centres harness our interdisciplinary expertise to solve the world's most pressing challenges.