Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter,randomized, parallel-group,controlled trial
Institution:
1. Department of Anesthesiology and Critical Care Medicine, Lapeyronie University Hospital, 34295 Montpellier Cedex 5, France;2. Inserm Unit 1298 Montpellier NeuroSciences Institute, Montpellier University, 34295 Montpellier Cedex 5, France;3. Department of Anesthesia and Pain Management, VinMec Hospital, Hanoi, Viet Nam;4. Department of Anesthesia and Intensive Care Medicine, Caremeau University Hospital, Nimes, France;5. Department of Medical Statistics, and Epidemiology, Montpellier University Hospital, 34295 Montpellier Cedex 5, France;1. Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, TX, USA;2. Outcomes Research Consortium, Cleveland, OH, USA;1. Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, 200 Lothrop Street, Pittsburgh, PA 15213, USA;2. Department of Bioengineering, Swanson School of Engineering, University of Pittsburgh, 302 Benedum Hall, Pittsburgh, PA 15261, USA;3. Center for the Neural Basis of Cognition, University of Pittsburgh, 4400 Fifth Avenue, Suite 115, Pittsburgh, PA 15213, USA;4. Clinical and Translational Science Institute, University of Pittsburgh, Forbes Tower, Suite 7057. Atwood and Sennott Streets. Pittsburgh, PA 15260, USA;5. McGowan Institute of Regenerative Medicine, University of Pittsburgh, 450 Technology Drive Suite 300, Pittsburgh, PA 15219-3110, USA;1. Department of Anesthesiology and Perioperative Medicine, London Health Sciences Center, Schulich School of Medicine and Dentistry, Western University, London, Canada;2. Department of Clinical Neurological Sciences, Division of Neurosurgery, London Health Sciences Center, Schulich School of Medicine and Dentistry, Western University, London, Canada;1. Department of Anesthesiology, Louisiana State University Health Sciences Center, New Orleans, LA 70112, USA;2. Department of Obstetrics and Gynecology, Weill Cornell Medical College, New York, NY 10065, USA
Abstract:
Study objectiveAfter surgery, patients reported the delay in receiving help as the primary factor for poorly controlled pain. This study aimed to compare the effectiveness of patient management through two communication modalities: remote transmission (RT) versus bedside control (BC). We hypothesized that using remote technology for pump programming may provide the best postoperative infusion regimen for the patient's self-assessment of pain and adverse events.DesignA multicenter, randomized, parallel-group, controlled trial.SettingAnesthesiology department and orthopedic surgery ward at three university hospitals.PatientsEighty patients undergoing orthopedic surgery with postoperative perineural patient-controlled analgesia were included.InterventionsTwo groups (n = 40 for each group) were formed by randomization. In the postoperative period, perineural analgesia was followed up via an RT system or BC for 72 h.MeasurementsA nurse assessed daily pain, sensory and motor blocks and adverse events. Patients completed a questionnaire three times a day and alerted for any problem according to the group (RT system or nurses' follow-up). On the third postoperative day, the nurse removed the catheter, completed the final assessment, and collected the historical data from the pump. A physician's shorter response time to change the patient control analgesia (PCA) program was the primary endpoint.ResultsOf the 80 patients, 71 were analyzed (34 were randomized to the RT group and 37 to the BC group). Fifty-eight pump setting changes were noted. Analysis of repeated evaluations shows that mean time (SD) to change the PCA pump settings was significantly lower in the RT group (20 min (22.3 min)) than in the BC group (55.9 min (71.1 min)); mean difference 95% CI], ?35.9 min ?74.3 to 2.4]); β estimation 95% CI], ?34 ?63 to ?6], p = 0.011). Pain relief, sensory and motor blocks did not differ between the groups: β estimation 95% CI], 0.1 ?0.4 to 0.6], p = 0.753; 0.5 ?0.4 to 1.4], p = 0.255; 0.9 ?0.04 to 1.8], p = 0.687, respectively. β = ?34 ?63 to ?6], p = 0.011). The consumption of ropivacaine, nurse workload and the cost of the analgesia regimen decreased in the RT group. No differences were noted in satisfaction scores or complication rates.ConclusionsThe response time for the physician to change the PCA program when necessary was shorter for patients using RT and alerts to the physician were more frequent compared with spot checks by nurses. RT helps to decrease nurses' workload, ropivacaine consumption, and costs but did not affect postoperative pain relief, complication rate, or patient-reported satisfaction score.IRB contact informationComité de Protection des Personnes, Sud Méditerranée III, Montpellier-Nîmes, France, registration number EudraCT A01698-35.Clinical trial numberClinicalTrials.gov ID:NCT02018068ProtocolThe full trial protocol can be accessed at Department of Anesthesiology and Critical Care Medicine, Medical Research and Statistics Unit, Lapeyronie University Hospital, Avenue Doten G Giraud, Montpellier, France. s-bringuierbranchereau@chu-montpellier.fr
