Study protocol for a pilot, randomised, double-blinded, placebo controlled trial of perineural local anaesthetics and steroids for chronic post-traumatic neuropathic pain in the ankle and foot: the PREPLANS study

INTRODUCTION Peripheral neuropathic pain (PNP) associated with trauma is often refractory to treatment. Administration of local anaesthetics (LA) and steroids around injured nerves has been proposed as an option for patients unresponsive to conventional treatments for refractory PNP following trauma. There is insufficient evidence to support a large, potentially expensive, full-scale randomised controlled trial (RCT) that involves comparison of effects of perineural steroids and LA against LA or saline injections on analgesia, physical and psychological functioning, and quality of life. There is also a lack of data that would allow estimation of analgesic efficacy or sample size for the full-scale RCT. The objective of this pilot RCT is to yield information to support planning of a full-scale RCT in this population. METHODS AND ANALYSIS 30 participants with post-traumatic PNP in the ankle and foot of moderate-to-severe intensity and duration of more than 3 months will be enrolled in this pilot RCT. Participants will be randomised to receive three ultrasound-guided perineural injections of 0.9% saline, 0.25% bupivacaine (a long-acting LA) or a combination of 0.25% bupivacaine and a steroid (methylprednisolone 16 mg per nerve) at weekly intervals. The primary objectives are to determine the feasibility and sample size of a full-scale RCT in this population. The secondary objectives are to evaluate the effect of study interventions on analgesia, persistence of neuropathic pain, psychological and physical function, quality of life and participants' global impression of change at 1 and 3 months after the interventions. In addition, adverse effects associated with perineural injections and with systemic absorption of steroids will also be recorded. ETHICS AND DISSEMINATION The protocol was approved by the University Health Network Research Ethics Board (UHN REB number 15-9584-A). The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER NCT02680548; Pre-results.