Pain Relief In Major Amputation (Prima) Protocol: A Single Centre RCT Comparing Pre-Incision Single-Shot Nerve Block And Patient Controlled Analgesia To Pre-Incision Peri-Neural Catheter, In Patients Undergoing Major Lower Limb Amputation

Introduction9663 major lower limb amputations were performed in UK NHS hospitals, between 2018-2020. Despite this high number, there is no universally accepted peri-operative analgesia regime. The Vascular Society and Vascular Anaesthesia Society of Great Britain and Ireland, in partnership with patients (supported by the James-Lind Alliance), have identified improving outcomes (including preventing/treating pain) for patients who undergo amputations as a key research priority. Methods and methodsA prospective, single-blind, RCT (1:1), comparing pre-incision ultrasound sited PNC (7-day duration) or pre-incision single-shot nerve block and PCA, for those undergoing MLLA. The sample size is 34 patients, powered to detect a primary outcome of 2.5cm(2cmSD) difference on a visual analogue scale (VAS) at day 3. Secondary outcomes include daily pain scores, analgesia use, post-operative nausea and vomiting, Pasero opioid-induced sedation scale and physiotherapy progress. Patient-reported neuropathic pain and quality of life tools (SF36 and EQ5D) are recorded at baseline, day-7, 6-weeks and one-year. Ethics and disseminationThis study was approved by South East Scotland Research Ethics Committee on 03/02/2021. REC reference:21/SS/0013). It is hoped this NIHR-portfolio adopted, RCS(Ed) funded RCT, will provide level-1 evidence for a shared patient and clinician research priority. Trial registration: ISRCTN.com, ISRCTN64207537. Registered on 21/07/2021