Soft System Based on Fiber Bragg Grating Sensor for Loss of Resistance Detection during Epidural Procedures: In Silico and In Vivo Assessment

Epidural analgesia represents a clinical common practice aiming at pain mitigation. This loco-regional technique is widely used in several applications such as labor, surgery and lower back pain. It involves the injections of anesthetics or analgesics into the epidural space (ES). The ES detection is still demanding and is usually performed by the techniques named loss of resistance (LOR). In this study, we propose a novel soft system (SS) based on one fiber Bragg grating sensor (FBG) embedded in a soft polymeric matrix for LOR detection during the epidural puncture. The SS was designed to allow instrumenting the syringe’s plunger without relevant modifications of the anesthetist’s sensations during the procedure. After the metrological characterization of the SS, we assessed the capability of this solution in detecting LOR by carrying it out in silico and in clinical settings. For both trials, results revealed the capability of the proposed solutions in detecting the LOR and then in recording the force exerted on the plunger.

[1]  F. Blyth,et al.  The Epidemiology of low back pain. , 2010, Best practice & research. Clinical rheumatology.

[2]  A. Cyna,et al.  Epidural versus non-epidural or no analgesia for pain management in labour. , 2018, The Cochrane database of systematic reviews.

[3]  S. Johnson,et al.  The effect of epidural anesthesia on the length of labor. , 1995, The Journal of family practice.

[4]  Emiliano Schena,et al.  FBG-based System for Loss of Resistance Detection During Epidural Injections , 2021, 2021 IEEE International Workshop on Metrology for Industry 4.0 & IoT (MetroInd4.0&IoT).

[5]  R. Derby,et al.  Epidural Injections for the Diagnosis and Treatment of Low-Back Pain , 1980, Spine.

[6]  Umesh Tiwari,et al.  Fiber grating sensors in medicine: Current and emerging applications , 2011 .

[7]  G Furness,et al.  An evaluation of ultrasound imaging for identificationof lumbar intervertebral level , 2002, Anaesthesia.

[8]  Emiliano Schena,et al.  Fiber Bragg Gratings for Medical Applications and Future Challenges: A Review , 2020, IEEE Access.

[9]  B. Kodali,et al.  The Learning Curve Associated with the Epidural Technique Using the Episure™ AutoDetect™ Versus Conventional Glass Syringe: An Open-Label, Randomized, Controlled, Crossover Trial of Experienced Anesthesiologists in Obstetric Patients , 2013, Anesthesia and analgesia.

[10]  Emiliano Schena,et al.  Force monitoring during Peripheral Nerve Blocks: design and feasibility assessment of a new noninvasive system , 2019, 2019 II Workshop on Metrology for Industry 4.0 and IoT (MetroInd4.0&IoT).

[11]  M. Curatolo,et al.  Pharmacologic Pain Treatment of Musculoskeletal Disorders: Current Perspectives and Future Prospects , 2001, The Clinical journal of pain.

[12]  Antonello Cutolo,et al.  Optical fiber technology enables smart needles for epidurals: an in-vivo swine study. , 2019, Biomedical optics express.

[13]  Cosimo Trono,et al.  Fiber Optic Sensors for Biomedical Applications , 2008 .

[14]  T. Lechner,et al.  Clinical results with a new acoustic device to identify the epidural space , 2002, Anaesthesia.

[15]  Ki Jinn Chin,et al.  Localization of epidural space: A review of available technologies , 2017, Journal of anaesthesiology, clinical pharmacology.

[16]  M. Yamakage,et al.  Epidrum®: a new device to identify the epidural space with an epidural Tuohy needle , 2012, Journal of Anesthesia.

[17]  Emiliano Schena,et al.  A New Pressure Guided Management Tool for Epidural Space Detection: Feasibility Assessment on a Simulator , 2017, Artificial organs.

[18]  T. Erdogan Fiber grating spectra , 1997 .

[19]  R. Wu,et al.  A 'membrane in syringe' technique that allows identification of the epidural space with saline while avoids injection of air into the epidural space. , 2002, Acta anaesthesiologica Sinica.

[20]  Sander Janssen,et al.  On using an array of fiber Bragg grating sensors for closed-loop control of flexible minimally invasive surgical instruments , 2013, 2013 IEEE/RSJ International Conference on Intelligent Robots and Systems.

[21]  Sotonye Fyneface-Ogan,et al.  Anatomy and Clinical Importance of the Epidural Space , 2012 .

[22]  Faisal Rafiq Mahmad Adikan,et al.  The Use of Fiber Bragg Grating Sensors in Biomechanics and Rehabilitation Applications: The State-of-the-Art and Ongoing Research Topics , 2012, Sensors.

[23]  Mariusz Krej,et al.  Monitoring Respiration and Cardiac Activity Using Fiber Bragg Grating-Based Sensor , 2012, IEEE Transactions on Biomedical Engineering.

[24]  Antonello Cutolo,et al.  Lab in a needle for epidural space identification , 2016, European Workshop on Optical Fibre Sensors.

[25]  R. Thomson,et al.  More in hope than expectation: a systematic review of women's expectations and experience of pain relief in labour , 2008, BMC medicine.

[26]  S. Campopiano,et al.  Fiber Bragg Grating Sensors for Temperature Monitoring During Thermal Ablation Procedure: Experimental Assessment of Artefact Caused by Respiratory Movements , 2021, IEEE Sensors Journal.

[27]  R. Setola,et al.  A new pressure guided management tool for epidural space detection: feasibility assessment in a clinical scenario. , 2020, Minerva anestesiologica.

[28]  R. Moore,et al.  Incidence of Epidural Hematoma, Infection, and Neurologic Injury in Obstetric Patients with Epidural Analgesia/Anesthesia , 2006, Anesthesiology.

[29]  D. Turnbull,et al.  Post-dural puncture headache: pathogenesis, prevention and treatment. , 2003, British journal of anaesthesia.

[30]  Shikha Ambastha,et al.  Spinal needle force monitoring during lumbar puncture using fiber Bragg grating force device , 2016, Journal of biomedical optics.

[31]  G Capogna,et al.  Experimental validation of the CompuFlo® epidural controlled system to identify the epidural space and its clinical use in difficult obstetric cases. , 2018, International journal of obstetric anesthesia.

[32]  Antonello Cutolo,et al.  Optical Guidance Systems for Epidural Space Identification , 2017, IEEE Journal of Selected Topics in Quantum Electronics.

[33]  Jin Yun Kim,et al.  Fluoroscope guided epidural needle insertioin in midthoracic region: clinical evaluation of Nagaro's method , 2012, Korean journal of anesthesiology.

[34]  S. Kim,et al.  Comparison of loss of resistance technique between Epidrum® and conventional method for identifying the epidural space , 2012, Korean journal of anesthesiology.

[35]  Arianna Menciassi,et al.  A Machine-Learning-Based Approach to Solve Both Contact Location and Force in Soft Material Tactile Sensors. , 2019, Soft robotics.

[36]  S. Segal,et al.  A Retrospective Effectiveness Study of Loss of Resistance to Air or Saline for Identification of the Epidural Space , 2010, Anesthesia and analgesia.