<b>Pain Relief After Instrumented Spinal surgEry trial (PRAISE Trial)</b>

<p dir="ltr">This is the Research Protocol for the PRAISE trial</p><p dir="ltr">This is a multicentre, parallel group, superiority, patient-blind, individual participant-randomised controlled trial to evaluate enhanced anaesthetic techniques, intrathecal opioids or Erector Spinae Plane Block (ESP block), in improving postoperative back pain on movement around the bed (sitting up and/or turning) at 24 hours compared to usual care in patients undergoing spinal surgery +/- decompression. The study will be conducted in around twenty-five NHS trusts and will involve an internal pilot to evaluate recruitment, site setup, pain scores and intervention delivery.</p><table><tr><td><p dir="ltr">IRAS Number: 1008666</p><p dir="ltr">ISRCTN: ISRCTN37852146</p><p dir="ltr">NIHR153170</p></td></tr><tr><td><p dir="ltr">REC Reference: 23/LO/0811</p><p dir="ltr">London - Westminster Research Ethics Committee</p></td></tr><tr><td><p><br></p></td></tr></table><p><br></p><p dir="ltr">The PRAISE trial was a multicentre, parallel group, superiority, patient-blinded, individual participant-randomised controlled trial (RCT) which was designed in response to an NIHR-HTA commissioned brief ‘22/30 Post-operative pain in patients undergoing spinal surgery’. The aim was to investigate the clinical and cost effectiveness of three approaches to postoperative pain relief following lumbar spine surgery in improving postoperative back pain on movement around the bed (sitting up and/or turning) at 24 hours: Usual Care vs Usual Care plus Intrathecal Opioid vs Usual Care plus Erector Spinae Plane block. The trial aimed to recruit 456 adults over 16 years old who were scheduled for elective, posterior lumbar-instrumented spinal surgery +/- decompression. The trial was run nationally within the UK. Primary outcome was back pain on movement around the bed (sitting up and/or turning) from Visual Analog Scale (VAS) recorded at 24 hours post-surgery. Secondary outcomes included patient reported measures to assess depression and anxiety, pain (back and leg, at rest and on movement), EQ-5D-5L, quality of recovery (QoR-15), healthcare resource use, Oswestry Disability Index to measure functional recovery. Clinical outcomes included cumulative opioid consumption after surgery, adverse events, further intervention, time to mobilisation, length of stay and readmissions. Participants were followed up until 6/8 weeks post surgery. An internal pilot was conducted 8 months into recruitment to assess feasibility of the trial, reviewing number of participants recruited, number of centres open, availability of pain score and intervention delivery.</p>