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
Forty patients with acute complete rupture of the calcaneal tendon were managed conservatively and randomly allocated to treatment groups using either cast immobilisation for eight weeks, or cast immobilisation for three weeks, followed by controlled early mobilisation in a Sheffield splint. The splint is an ankle-foot orthosis which holds the ankle in 15 degrees of plantar flexion, but allows some movement at the metatarsophalangeal joints. It is removed to allow controlled movement during physiotherapy. Patients treated with the splint regained mobility significantly more quickly (p less than 0.001) and preferred the splint to the plaster cast. The range of dorsiflexion at the ankle improved more rapidly after treatment in the splint (p less than 0.001), and patients were able to return to normal activities sooner. Recovery of the power of plantar flexion was similar in the two treatment groups, and no patient had excessive lengthening of the tendon. One re-rupture occurred in each group.
