BackgroundUse of minimally invasive surgical techniques for lung resection surgery (LRS), such as video-assisted thoracoscopy (VATS), has increased in recent years. However, there is little information about the best anesthetic technique in this context. This surgical approach is associated with a lower intensity of postoperative pain, and its use has been proposed in programs for enhanced recovery after surgery (ERAS). This study compares the severity of postoperative complications in patients undergoing LRS who have received lidocaine intraoperatively either intravenously or via paravertebral administration versus saline.Methods/designWe will conduct a single-center randomized controlled trial involving 153 patients undergoing LRS through a thoracoscopic approach. The patients will be randomly assigned to one of the following study groups: intravenous lidocaine with more paravertebral thoracic (PVT) saline, PVT lidocaine with more intravenous saline, or intravenous remifentanil with more PVT saline. The primary outcome will be the comparison of the postoperative course through Clavien-Dindo classification. Furthermore, we will compare the perioperative pulmonary and systemic inflammatory response by monitoring biomarkers in the bronchoalveolar lavage fluid and blood, as well as postoperative analgesic consumption between the three groups of patients. We will use an ANOVA to compare quantitative variables and a chi-squared test to compare qualitative variables.DiscussionThe development of less invasive surgical techniques means that anesthesiologists must adapt their perioperative management protocols and look for anesthetic techniques that provide good analgesic quality and allow rapid rehabilitation of the patient, as proposed in the ERAS protocols. The administration of a continuous infusion of intravenous lidocaine has proven to be useful and safe for the management of other types of surgery, as demonstrated in colorectal cancer. We want to know whether the continuous administration of lidocaine by a paravertebral route can be substituted with the intravenous administration of this local anesthetic in a safe and effective way while avoiding the risks inherent in the use of regional anesthetic techniques. In this way, this technique could be used in a safe and effective way in ERAS programs for pulmonary resection.Trial registrationEudraCT, 2016–004271-52; ClinicalTrials.gov, NCT03905837. Protocol number IGGFGG-2016 version 4.0, 27th April 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3677-9) contains supplementary material, which is available to authorized users.
Background and aims: Pain management constitutes an organisational challenge in all types of clinical establishments. The ISO 9001 Norms can be an effective way of integrating the different components of a comprehensive multidisciplinary programme. ISO 9001 International Standards ensure that products and services are safe, reliable and of good quality. The experience of applying the ISO 9001 norms for the effective management of pain in a large university hospital is shown here. Methods: A Multidisciplinary Pain Committee was created in a 1,400-bed university hospital in Madrid (Spain). Nineteen doctors from 17 specialties, 3 nurses, one pharmacist and one of the hospital directors were integrated in six working groups with the objective of implementing the necessary steps leading to the ISO 9001 Quality Certification of the organisation. A process map was designed, operating procedures were developed and quality indicators were chosen. A quality manual and a welcome manual were written, policies for risk management and data protection were outlined, and a critical incidents registry was created. Setting up the process and completing the tasks took around one and a half years. Results: After the effective implementation of all of the ISO 9001 recommendations, process management became the regular methodology for work in the different areas integrated in the institutional pain programme. A quality committee monitored both the compliance with the norms and the data derived from the quality indicators. Once the committee was satisfied with the results, an accredited agency (Bureau Veritas Certification) for the external audit was chosen. The ISO 9001 Quality Certificate was awarded in March 2013. Conclusions: ISO 9001 international standards can be effectively applied to a multidisciplinary pain programme in a tertiary care hospital. Process management can be a useful methodology for work leading to efficiency, safety and quality.
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