PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia.

INTRODUCTION: Studies finding perioperative hyperglycaemia is associated with adverse patient outcomes in surgical procedures spurred the development of blood glucose guidelines at many institutions. In this trial, we will assess the implementation of a clinical decision support tool that is integrated into the intraoperative portion of our electronic health record and provides real-time best practice recommendations for intraoperative insulin dosing in surgical patients at high risk for hyperglycaemia. METHODS AND DESIGN: We will assess this intervention using a sequential and repeated cross-over design at the institutional level with periods of time for wash-out, control and study intervention. The unit of analysis will be the surgical case. The primary outcome will be the frequency of hyperglycaemia (>180 mg/dL (10 mmol/L)) at first postoperative anaesthesia care unit measurement. There are several prespecified secondary analyses focused on perioperative glycaemic control. DISCUSSION: This protocol and statistical analysis plan describes the methodology, primary and secondary analyses. The PeRiOperative Glucose PRAgMatic (PROGRAM) trial was approved by the Vanderbilt University Institutional Review Board (IRB), Vanderbilt University Medical Center, Nashville, Tennessee, USA (IRB, 220991). The study results will be disseminated via publication in a peer-reviewed journal and presented at national scientific conferences. The results of PROGRAM trial will inform best practice for perioperative standardised insulin administration in surgical patients at high risk of hyperglycaemia. TRIAL REGISTRATION NUMBER: NCT05426096.

Complex regional pain syndrome: state of the art update.

OPINION STATEMENT: Although the pathophysiology of complex regional pain syndrome (CRPS) is not fully understood, it appears to reflect multiple interacting mechanisms. In addition to altered autonomic function, a role for inflammatory mechanisms and altered somatosensory and motor function in the brain is increasingly suggested. Several possible risk factors for development of CRPS, including genetic factors, have been identified. Few treatments have been proven effective for CRPS in well-designed clinical trials. However, recent work suggests that bisphosphonates may be useful in CRPS management and that the N-methyl-D: -aspartate receptor antagonist ketamine significantly reduces CRPS pain when administered topically or intravenously at subanesthetic dosages. Extended use of ketamine at anesthetic dosages ("ketamine coma") remains a controversial and unproven treatment for CRPS. Spinal cord stimulation may be effective for reducing pain in approximately two thirds of CRPS patients not responding to other treatments, but its efficacy appears to diminish over time.