PRAISE trial - Statistical Analysis Plan

The PRAISE Statistical Analysis Plan (version 1) sets out the finalised planned schedule of data analyses for the PRAISE trial (ISRCTN37852146, REC 23/LO/0811, IRAS 1008666), based on the PRAISE trial Protocol version 4.0, 5th August 2025 (https://doi.org/10.15131/shef.data.30479879).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. See PRAISE Protocol (https://doi.org/10.15131/shef.data.30479879) for further details regarding the trial.