The VertiGO! Trial protocol: A prospective, single-center, patient-blinded study to evaluate efficacy and safety of prolonged daily stimulation with a multichannel vestibulocochlear implant prototype in bilateral vestibulopathy patients.

BACKGROUND: A combined vestibular (VI) and cochlear implant (CI) device, also known as the vestibulocochlear implant (VCI), was previously developed to restore both vestibular and auditory function. A new refined prototype is currently being investigated. This prototype allows for concurrent multichannel vestibular and cochlear stimulation. Although recent studies showed that VCI stimulation enables compensatory eye, body and neck movements, the constraints in these acute study designs prevent them from creating more general statements over time. Moreover, the clinical relevance of potential VI and CI interactions is not yet studied. The VertiGO! Trial aims to investigate the safety and efficacy of prolonged daily motion modulated stimulation with a multichannel VCI prototype. METHODS: A single-center clinical trial will be carried out to evaluate prolonged VCI stimulation, assess general safety and explore interactions between the CI and VI. A single-blind randomized controlled crossover design will be implemented to evaluate the efficacy of three types of stimulation. Furthermore, this study will provide a proof-of-concept for a VI rehabilitation program. A total of minimum eight, with a maximum of 13, participants suffering from bilateral vestibulopathy and severe sensorineural hearing loss in the ear to implant will be included and followed over a five-year period. Efficacy will be evaluated by collecting functional (i.e. image stabilization) and more fundamental (i.e. vestibulo-ocular reflexes, self-motion perception) outcomes. Hearing performance with a VCI and patient-reported outcomes will be included as well. DISCUSSION: The proposed schedule of fitting, stimulation and outcome testing allows for a comprehensive evaluation of the feasibility and long-term safety of a multichannel VCI prototype. This design will give insights into vestibular and hearing performance during VCI stimulation. Results will also provide insights into the expected daily benefit of prolonged VCI stimulation, paving the way for cost-effectiveness analyses and a more comprehensive clinical implementation of vestibulocochlear stimulation in the future. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04918745. Registered 28 April 2021.

Pain Management After Hip Arthroscopy: Systematic Review of Randomized Controlled Trials and Cohort Studies.

BACKGROUND: Hip arthroscopy is often associated with significant postoperative pain and opioid-associated side effects. Effective pain management after hip arthroscopy improves patient recovery and satisfaction and decreases opioid-related complications. PURPOSE: To collect, examine, and provide a comprehensive review of the available evidence from randomized controlled trials and comparative studies on pain control after hip arthroscopy. STUDY DESIGN: Systematic review. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, a systematic review of the literature for postoperative pain control after hip arthroscopy was performed using electronic databases. Only comparative clinical studies with level 1 to 3 evidence comparing a method of postoperative pain control with other modalities or placebo were included in this review. Case series and studies without a comparative cohort were excluded. RESULTS: Several methods of pain management have been described for hip arthroscopy. A total of 14 studies met our inclusion criteria: 3 on femoral nerve block, 3 on lumbar plexus block, 3 on fascia iliaca block, 4 on intra-articular injections, 2 on soft tissue surrounding surgical site injection, and 2 on celecoxib (4 studies compared 2 or more methods of analgesia). The heterogeneity of the studies did not allow for pooling of data. Single-injection femoral nerve blocks and lumbar plexus blocks provided improved analgesia, but increased fall rates were observed. Fascia iliaca blocks do not provide adequate pain relief when compared with surgical site infiltration with local anesthetic and are associated with increased risk of cutaneous nerve deficits. Patients receiving lumbar plexus block experienced significantly decreased pain compared with fascia iliaca block. Portal site and periacetabular injections provide superior analgesia compared with intra-articular injections alone. Preoperative oral celecoxib, compared with placebo, resulted in earlier time to discharge and provided significant pain relief up to 24 hours. CONCLUSION: Perioperative nerve blocks provide effective pain management after hip arthroscopy but must be used with caution to decrease risk of falls. Intra-articular and portal site injections with local anesthetics and preoperative celecoxib can decrease opioid consumption. There is a lack of high-quality evidence on this topic, and further research is needed to determine the best approach to manage postoperative pain and optimize patient satisfaction.