Effectiveness and cost-effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures: protocol for a multicentre, two-armed, parallel-group randomised controlled trial with 12 months of follow-up.

INTRODUCTION: Patients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a need for evidence-based conservative treatment to aid in the management of OVCFs. The objective of this randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of dynamic bracing in addition to standard care for improving quality of life (QoL) in patients suffering from an OVCF. METHODS AND ANALYSIS: Ninety-eight postmenopausal women from two academic and four community hospitals with a recent symptomatic thoracolumbar OVCF will be randomised into either the standard care or dynamic bracing group. In the dynamic bracing group, the Spinova Osteo orthosis will be used in addition to standard care. Standard care comprises pain control with analgesics, physical therapy and osteoporosis medication. The primary outcome parameter is QoL 1 year after inclusion, as measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. A trial-based economic evaluation consisting of both cost-effectiveness analysis and cost-utility analysis will be performed based on empirical data obtained in the RCT. A process evaluation will assess the feasibility of dynamic bracing. All outcomes will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee, University Hospital Maastricht and Maastricht University (METC azM/UM) (NL74552.068.20/METC 20-055). Patients will be included only after verification of eligibility and obtaining written informed consent. Results will be disseminated via the Dutch National Osteoporosis Patient Society and via publications and conferences. TRIAL REGISTRATION NUMBER: NL8746.

Evaluation of adding the Erector spinae plane block to standard anesthetic care in patients undergoing posterior lumbar interbody fusion surgery.

Postoperative analgesia in patients undergoing spinal fusion surgery is challenging due to the invasiveness of the surgical procedure and the frequent use of opioids preoperatively by many patients. Recently, the erector spinae plane (ESP) block has been introduced in our clinical practice as part of a multimodal pain strategy after posterior lumbar interbody fusion surgery. This is a retrospective case-control study evaluating the analgesic efficacy of the ESP block when added to our standard analgesic regimen for posterior lumbar interbody fusion surgery. Twenty patients who received an erector spinae plane block were compared with 20 controls. The primary endpoint was postoperative pain, measured by the numeric rating scale. Secondary outcome measures were opioid use, postoperative nausea and vomiting, and length of stay. Postoperative pain scores in the PACU were lower in patients who received an erector spinae plane block (p = 0.041). Opioid consumption during surgery and in the PACU was not significantly different. Need for patient-controlled analgesia postoperatively was significantly lower in the group receiving an ESP block (p = 0.010). Length of stay in hospital was reduced from 3.23 days (IQR 1.1) in the control group to 2.74 days (IQR 1.6) in the study group (p = 0.012). Adding an erector spinae plane block to the analgesic regimen for posterior lumbar interbody fusion surgery seemed to reduce postoperative pain and length of hospital stay.