PRAISE
Research type
Research Study
Full title
Pain Relief After Instrumented Spinal surgEry trial (PRAISE Trial)
IRAS ID
1008666
Contact name
Matthew Wilson
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Research summary
Spinal surgery is common in the NHS and can result in severe postoperative pain limiting recovery and rehabilitation. Pain after instrumented lumbar spinal surgery is severe and can persist for many weeks, with a mean length of hospital stay of 4.7 days. Severe postoperative pain can delay early mobilisation, with potential complications such as venous thromboembolism and infection, all of which carry costs for the NHS. The treatments under evaluation each carry a different harm:benefit profile. Multimodal analgesia with strong opioids (Usual Care) is standard treatment but there is some evidence from systematic reviews that the alternatives offer superior pain relief. Both intrathecal opioids and ESB are currently used in some centres, but without a rational basis for treatment selection in scientific evidence.
The PRAISE trial aims to investigate the clinical and cost effectiveness of three approaches to postoperative pain relief following lumbar spine surgery: Control (Usual care), Intervention 1 (Intrathecal Opioid injection) or Intervention 2 (Erector Spinae plane Block). The trial will recruit 456 participants aged >16 scheduled for elective posterior lumbar-instrumented spinal surgery who are able to give informed consent. Patients will be randomised 1:1:1.
The primary outcome is back pain on moving around bed (sitting up and/or turning) on a 0-100 VAS at 24 hours post-surgery. Secondary outcomes include EQ-5D-5L, back pain at rest, leg pain, QoR-15, cumulative postoperative opioid consumption, quality of life, time to mobilisation, length of stay, adverse events and healthcare resource use. Parallel economic evaluation with the trial will estimate incremental cost-effectiveness ratios. Outcomes will be collected at baseline, on admission to theatre recovery, at 6, 24 and 72 hours after surgery, and at routine 6-8 week follow up.
REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0811
Date of REC Opinion
2 Nov 2023
REC opinion
Further Information Favourable Opinion