Over 55,000 spinal operations are performed annually in the NHS. Effective postoperative analgesia facilitates early mobilisation and assists rehabilitation and hospital discharge, but is difficult to achieve with conventional, opioid-based, oral analgesia. The clinical and cost-effectiveness of two alternative techniques, namely intrathecal opioid and the more novel erector-spinae plane blockade, is unknown. The Pain Relief After Instrumented Spinal Surgery (PRAISE) trial aims to evaluate these techniques. PRAISE is a multicentre, prospective, parallel group, patient-blinded, randomised trial, seeking to recruit 456 adult participants undergoing elective, posterior lumbar-instrumented spinal surgery from up to 25 NHS hospitals. Participants will be randomised 1:1:1 to receive (1) Usual Care with local wound infiltration, (2) Intrathecal Opioid plus Usual Care with local wound infiltration or (3) Erector Spinae Plane blockade plus Usual Care with no local wound infiltration. The primary outcome is pain on movement on a 100mm visual analogue scale at 24 hours post-surgery. Secondary outcomes include pain at rest, leg pain, quality of recovery (QoR-15), postoperative opioid consumption, time to mobilisation, length of hospital stay, health utility (EQ-5D-5L), adverse events and resource use. Parallel economic evaluation will estimate incremental cost-effectiveness ratios.Background
Methods
Management of irreparable rotator cuff tears is challenging and controversial. Surgeons have been utilising biological tissue scaffolding to augment repairs, but there are concerns regarding viability and function. We wished to investigate this viability and clinical outcome in a small group of patients. All procedures were performed by a single surgeon over a three-year period. Inclusion criteria were patients with large cuff tears and failure of non-operative treatment. Exclusion criteria were patients with glenohumeral arthritis and where cuff repair could not be successfully performed. Open rotator cuff repair followed by augmentation with Graft Jacket® Regenerative Tissue Matrix (Wright Medical) was performed in all patients. A structured cuff repair physiotherapy protocol was then followed. Follow-up was at six months and at minimum twenty-four months post-operatively where Constant scores (CS) and Oxford Shoulder scores (OSS) were noted and a repeat ultrasound performed. Fourteen patients underwent the procedure. No patient was lost to follow-up. There were seven males and seven females with a mean age of 63 years (range 31–77). At minimum twenty-four month follow-up, thirteen patients had flexion and abduction above 90 degrees and symmetrical external rotation. Mean CS was 81 (range 70–91) and mean OSS was 46 (range 41–48). Shoulder ultrasound revealed an intact Graft Jacket® in all thirteen patients. The final patient had lower functional movement and lower CS (34) and OSS (25) and ultrasound identified a re-rupture. This study indicates that augmentation of large rotator cuff repairs with biological tissue scaffolding is a viable option and has good functional results.
