Strategy to secure the neuraxial route in anaesthesia: Risk mapping and feedback from the application of the ISO 80369-6 standard NRFit® connectors.

INTRODUCTION: In anesthesia, a medication error would occur every 20 to 133 anesthesia procedures, and 14% is related to a route administration error. To secure neuraxial route, ISO group published a norm in 2016 to develop specific connectors, the "NRFit® connector". The main objective of this work, is to develop a risk mapping related to neuraxial medication errors therefore prepare the NRFit® implementation in anesthesia units in a French Universitary Hospital. METHODS: Failure modes, effects and criticality analysis (FMECA) methodology was used for our risk mapping which was divided in 3 anesthesia specialities. For each, the analysis was performed for accidental neuraxial administration of intravenous drugs, and its opposite error. Secondly, NRFit® devices were tested for 1 month by 3 experimented anesthetists. RESULTS: The majority of reported errors concerns epidural and intrathecal anesthesia, and more frequently in the field of obstetrics. Opioids and tranexamic acid, administered in neuraxial route, are drugs with the highest criticality. The tests were rather conclusive and made it possible to highlight the additional needs in medical devices. DISCUSSION: Obstetrics is the riskiest area due to the frequency of epidural anesthesia, the administration of critical drugs in intravenous and neuraxial route. This work increased the awareness of our group, improved the measure of this risk and harmonized practices. CONCLUSION: This work is the first step of the project to prevent administration route error in anesthesia during patient's drug management. The next step will be the NRFit® implementation for epidural and combined spinal-epidural anesthesia in our hospital.

Loss-of-Resistance Versus Dynamic Pressure-Sensing Technology for Successful Placement of Thoracic Epidural Catheters: A Randomized Clinical Trial.

BACKGROUND: The traditional loss-of-resistance (LOR) technique for thoracic epidural catheter placement can be associated with a high primary failure rate. In this study, we compared the traditional LOR technique and dynamic pressure-sensing (DPS) technology for primary success rate and secondary outcomes pertinent to identifying the thoracic epidural space. METHODS: This pragmatic, randomized, patient- and assessor-blinded superiority trial enrolled patients ages 18 to 75 years, scheduled for major thoracic or abdominal surgeries at a tertiary care teaching hospital. Anesthesiology trainees (residents and fellows) placed thoracic epidural catheters under faculty supervision and rescue. The primary outcome was the success rate of thoracic epidural catheter placement, evaluated by the loss of cold sensation in the thoracic dermatomes 20 minutes after injecting the epidural test dose. Secondary outcomes included procedural time, ease of catheter placement, the presence of a positive falling meniscus sign, early hemodynamic changes, and unintended dural punctures. Additionally, we explored outcomes that included number of attempts, needle depth to epidural space, need for faculty to rescue the procedure from the trainee, patient-rated procedural discomfort, pain at the epidural insertion site, postoperative pain scores, and opioid consumption over 48 hours. RESULTS: Between March 2019 and June 2020, 133 patients were enrolled; 117 were included in the final analysis (n = 57 for the LOR group; n = 60 for the DPS group). The primary success rate of epidural catheter placement was 91.2% (52 of 57) in the LOR group and 96.7% (58 of 60) in the DPS group (95% confidence interval [CI] of difference in proportions: -0.054 [-0.14 to 0.03]; P = .264). No difference was observed in procedural time between the 2 groups (median interquartile range [IQR] in minutes: LOR 5.0 [7.0], DPS 5.5 [7.0]; P = .982). The number of patients with epidural analgesia onset at 10 minutes was 49.1% (28 of 57) in the LOR group compared to 31.7% (19 of 60) in the DPS group ( P = .062). There were 2 cases of unintended dural punctures in each group. Other secondary or exploratory outcomes were not significantly different between the groups. CONCLUSIONS: Our trial did not establish the superiority of the DPS technique over the traditional LOR method for identifying the thoracic epidural space ( Clinicaltrials.gov identifier: NCT03826186).

Intrathecal catheter use after accidental dural puncture in obstetric patients: literature review and clinical management recommendations.

If an accidental dural puncture occurs, one option is to insert a catheter and use it as an intrathecal catheter. This avoids the need for a further injection and can rapidly provide labour analgesia and anaesthesia for caesarean section. However, there are no recommendations for managing intrathecal catheters and, therefore, significant variation in clinical practice exists. Mismanagement of the intrathecal catheter can lead to increased motor block, high spinal anaesthesia, drug error, hypotension and fetal bradycardia. Care must be taken with an intrathecal catheter to adhere to strict aseptic technique, meticulous labelling, cautious administration of medications and good communication with the patient and other staff. Every institution considering the use of intrathecal catheters should establish a protocol. For labour analgesia, we recommend the use of dilute local anaesthetic agents and opioids. For caesarean section anaesthesia, gradual titration to the level of the fourth thoracic dermatome, with full monitoring, in a facility equipped to manage complications, should be performed using local anaesthetics combined with lipophilic opioids and morphine or diamorphine. Although evidence of the presence and duration of intrathecal catheters on the development of post-dural puncture headache and need for epidural blood patch is limited, we suggest considering leaving the intrathecal catheter in for 24 hours to reduce the chance of developing a post-dural puncture headache while maintaining precautions to avoid drug error and cerebrospinal fluid leakage. Injection of sterile normal saline into the intrathecal catheter may reduce post-dural puncture headache. The level of evidence for these recommendations was low.

Feasibility study of a force-sensing resistor device for landmark detection for neuraxial procedures and anesthesiologists' impact on device improvement.

The standard of care for neuraxial procedures is landmark palpation to determine the site of placement. This research study aimed to test the primary feasibility of VerTouch™, a force-sensing resistor device, to identify landmarks for the initiation of neuraxial procedures. Patients were recruited at the time of labour epidural, or when consenting for spinal anaesthesia for caesarean delivery at a single centre. The clinical team used the device to create a pressure map image of the bony spine. If they felt confident, they used the device guide to make a mark on the patient's back. If the mark was used, total insertions and redirections, combined as passes, of the needle during the procedure were counted for secondary outcome analysis. A total of 101 parturients were recruited, and the provider felt confident making a mark based on the imaging in 96.9% of cases. Device success (completion using the mark and ≤4 total passes) occurred in 91.4% of cases. This feasibility study showed that the primary outcome, the provider using the device to make a mark, was successful. In addition, based on comparing passes with historical data, the Vertouch™ device showed promise for future use to minimise needle manipulation in neuraxial procedures.

Thoracic caudal epidural catheter localization using ultrasound guidance.

Caudal epidural catheters provide exceptional analgesia while avoiding or minimizing opioids. Historically, the catheter tip location (dermatomal level) was estimated or verified via epidurogram. According to the Pediatric Regional Anesthesia Database, the majority of caudal-to-thoracic epidural catheters are placed without imaging guidance or verification of the position of the catheter tip. Ponde et al demonstrated that catheter insertion depth was longer when using ultrasound guidance than when estimated by external measurement. We report a simple yet novel ultrasound approach for catheter localization.

Efficacy of the Epidural Positioning Device® in optimizing the acoustic target window for neuraxial needle placement in term pregnancy.

BACKGROUND: Neuraxial anesthesia can be challenging in obstetric patients due to the gravid uterus interfering with patient positioning. Ultrasound is commonly used in obstetric anesthesia to facilitate neuraxial needle placement. Some positioning maneuvers facilitate the ultrasound visualization of structures and the placement of neuraxial needles, but the Epidural Positioning Device (EPD) has yet to be evaluated. OBJECTIVES: Our goal was to evaluate whether the use of the EPD increased the acoustic target window in the lumbar area of pregnant patients. We hypothesized that the application of the EPD would increase the measured lengths of the paravertebral longitudinal ligament (PLL), the interlaminar distance (ILD) and the ligamentum flavum (LF). METHODS: Lumbar ultrasonography was performed on 29 pregnant women having an elective cesarean delivery. Two anesthesiologists independently scanned the L3-4 right paramedian space, using a curvilinear ultrasound transducer, in two positions for each patient: traditional sitting with lumbar flexion and sitting with use of the EPD for lumbar flexion. The PLL, ILD and LF lengths were measured using the ultrasound caliper software and recorded, with the anesthesiologists blinded to the results. Patients were asked to rate their comfort in both positions. RESULTS: There were no significant differences between the measured lengths of the PLL, ILD and LF in the two positions. Patient comfort was significantly higher with use of the EPD (OR 10, 95% CI 2.4 to 88). CONCLUSION: Although the application of an EPD did not improve the paramedian acoustic target area in term parturients, greater patient comfort might facilitate needle placement.

The effect of additional transforaminal epidural blocks on percutaneous epidural neuroplasty with a wire-type catheter: A retrospective observational study.

Percutaneous epidural neuroplasty (PEN) is an effective interventional treatment for radicular pain. However, in some cases, contrast runoff to the spinal nerve root does not occur. We investigated whether contrast runoff to the spinal nerve root affects the success rate of PEN and whether additional transforaminal epidural blocks for intentional contrast runoff affect the success rate of PEN in cases in which contrast runoff is absent.This study was registered at ClinicalTrials.gov (Identifier: NCT03867630) in March 2019. We reviewed the medical records of 112 patients who underwent PEN with a wire-type catheter from May 2016 to August 2018. Patients were divided in 3 groups (Runoff group, Non-runoff group, Transforaminal group).Patients with low back pain and leg radicular pain who did not respond to lumbar epidural steroid injectionsPEN was performed in 112 patients with a wire-type catheter in target segment. We compared the success rate of PEN betweenThe success rate was significantly different between the Runoff group and the Non-runoff group (P < .0007) and between the Non-runoff group and the Transforaminal group (P = .0047), but not between the Runoff group and the Transforaminal group (P = .57).Contrast runoff influenced the success rate of PEN. In cases without contrast runoff, additional transforaminal epidural blocks for intentional contrast runoff increased the success rate of PEN with a wire-type catheter.

[Identification of the epidural space using pressure waveform analysis (CompuFlo® technology): a case series]. / Identifikation des Epiduralraums mithilfe einer Druckkurvenanalyse (CompuFlo®-Technologie): eine Fallserie.

Anesthesiologists commonly perform the loss of resistance technique in order to identify the epidural space during neuraxial procedures; however, this technique is subjective and lacks reliability in certain cases. The so-called CompuFlo® technology provides objective information about the position of the epidural needle by means of a pressure curve and acoustic signals. The technology was introduced several years ago and was evaluated in several trials, which showed promising results. The purpose of the present publication is to report on the first experiences with the CompuFlo® technology in German-speaking countries. A series of 24 epidural procedures using the CompuFlo® device was carried out in routine daily practice. The epidural space was successfully identified in 23 cases. Conversion to the conventional loss of resistance technique was performed during the initial cases in a prolonged procedure. The CompuFlo® technique is considered to be a promising technology, which might help to reduce complications after epidural anesthesia, e.g. postdural puncture headache.

Comparison of Intravascular Injection Rate Between Blunt and Sharp Needles During Cervical Transforaminal Epidural Block.

BACKGROUND: Cervical transforaminal epidural block (CTEB) is a useful option in the diagnosis and treatment of cervical radicular pain. However, inadvertent intravascular injection can lead to severe neurologic complications. Blunt needles are considered to displace instead of penetrate vessels because of their dull needle tip. OBJECTIVES: To investigate whether there is a difference between blunt and sharp needles in intravascular injection rates during CTEB. STUDY DESIGN: Prospective, randomized, clinical trial. SETTING: A tertiary hospital in South Korea. METHODS: After institutional review board approval, 108 patients undergoing CTEB for treatment of radicular pain resulting from spinal stenosis and herniated nucleus pulposus were randomly assigned to one of 2 needle groups (blunt needle or sharp needle). The needle position was confirmed using biplanar fluoroscopy, and 2 mL of nonionic contrast medium was injected to detect intravascular injection. Intravascular injection was defined as the contrast medium spreading out through the vascular channel during injection under real-time fluoroscopy. This study was registered in ClinicalTrials.gov. RESULTS: The intravascular injection rate was not significantly different between the blunt needle and sharp needle groups (35.2% vs. 33.3%, P > 0.05). The procedure time was longer in the blunt needle group than in the sharp needle group (101.00 ± 12.4 seconds vs. 56.67 ± 8.3 seconds, P < 0.001). LIMITATIONS: This was a single-center study. Additionally, the physicians could not be blinded to the type of needle used. CONCLUSIONS: In the present study, use of a blunt needle did not reduce the rate of intravascular injection during CTEB compared to use of a sharp needle. In addition, procedure time significantly increased with blunt needle use compared to sharp needle use. KEY WORDS: Analgesia, bleeding, blunt needle, cervical spine, clinical trials, complications, intravascular injection, radiculopathy, sharp needle, transforaminal epidural block.

Central neurological complications following obstetric neuraxial blockade.

PURPOSE OF REVIEW: Central neuraxial blockade is increasingly the anaesthetic management of choice for parturients, including in higher risk pregnancies. Although they are usually effective and safe, there are potentially devastating neurological complications that may present either overtly or insidiously. A thorough understanding of the variety of potential neurological complications is essential to adequately consent patients in addition to diagnosing and managing complications following neuraxial anaesthesia. This review aims to describe a number of potential neurological injuries that may occur and suggested management based on available evidence. RECENT FINDINGS: Current evidence supports neuraxial anaesthesia as a safe management strategy in low and many higher risk pregnancies, with a low overall incidence of neurological complications. Neuraxial blockade is safe in patients with platelet counts greater than 70 000/µl and the risk of infective complications secondary to epidural catheterization remains low until day five post procedure. There is also some early evidence supporting the use of transnasal local anaesthetic as a strategy for managing postdural puncture headache. SUMMARY: Difficulty remains in establishing absolute risk of complications and optimal management strategies given the low overall number of patients affected and heterogeneity of therapy. There may be a role for centralized registration of postneuraxial complications in obstetric patients to further develop our collective understanding of these conditions.

Low-dose spinal anesthesia for cesarean section to prevent spinal-induced hypotension.

PURPOSE OF REVIEW: Low-dose combined spinal epidural (CSE) anesthesia is a common technique to anesthetize women for cesarean section. It is used to reduce the incidence of hypotension while providing excellent anesthetic conditions. RECENT FINDINGS: Low spinal doses produce effective anesthesia but of limited duration. Therefore, an epidural catheter (and thus CSE) is required to guarantee pain-free surgery. Recent work confirmed that lower spinal doses can reduce significantly hypotension. SUMMARY: Low-dose CSE is a valuable strategy to anesthetize pregnant women for cesarean section but requires attention and training.

Resident Competency and Proficiency in Combined Spinal-Epidural Catheter Placement Is Improved Using a Computer-Enhanced Visual Learning Program: A Randomized Controlled Trial.

BACKGROUND: Physician educators must balance the need for resident procedural education with clinical time pressures as well as patient safety and comfort. Alternative educational strategies, including e-learning tools, may be beneficial to orient novice learners to new procedures and speed proficiency. We created an e-learning tool (computer-enhanced visual learning [CEVL] neuraxial) to enhance trainee proficiency in combined spinal-epidural catheter placement in obstetric patients and performed a randomized controlled 2-center trial to test the hypothesis that use of the tool improved the initial procedure performed by the anesthesiology residents. METHODS: Anesthesiology residents completing their first obstetric anesthesiology rotation were randomized to receive online access to the neuraxial module (CEVL group) or no access (control) 2 weeks before the rotation. On the first day of the rotation, residents completed a neuraxial procedure self-confidence scale and an open-ended medical knowledge test. Blinded raters observed residents performing combined spinal-epidural catheter techniques in laboring parturients using a procedural checklist (0-49 pts); the time required to perform the procedure was recorded. The primary outcome was the duration of the procedure. RESULTS: The CEVL group had significantly shorter mean (±standard deviation) procedure time compared to the control group 22.5 ± 4.9 vs 39.5 ± 7.1 minutes (P < .001) and had higher scores on the overall performance checklist 36.4 ± 6.6 vs 28.8 ± 7.1 (P = .012). The intervention group also had higher scores on the open-ended medical knowledge test (27.83 ± 3.07 vs 22.25 ± 4.67; P = .002), but self-confidence scores were not different between groups (P = .64). CONCLUSIONS: CEVL neuraxial is a novel prerotation teaching tool that may enhance the traditional initial teaching of combined spinal-epidural procedures in obstetric anesthesiology. Future research should examine whether the use of web-based learning tools impacts long-term provider performance or patient outcomes.

The Effectiveness of Applying Soft Tissue Bonding Adhesive Composed of 2-Ethyl Cyanoacrylate to Epidural Catheter Fixations Using Film Dressings: An Open-Label, Randomized, Parallel-Group Comparative Study.

BACKGROUND: Insufficient fixation of an epidural catheter may result in migration of the catheter and eventual catheter failure. However, the best fixation method remains to be established. Aron Alpha A (2-ethyl cyanoacrylate) adhesive is approved for clinical use and can be used for surgical adhesion to both skin and blood vessels. We hypothesized that the addition of Aron Alpha A adhesive to film dressing would result in consistent and dependable catheter fixation. METHODS: In this study, 58 women who were scheduled for cesarean delivery under spinal and epidural anesthesia were recruited. Patients were randomly assigned to a control or treatment group. In the control group, the catheter was fixed solely by film dressing. In the treatment group, a small amount of Aron Alpha A was applied at 2 sites along the catheter. The fixation area was then covered by film dressing. The catheter insertion length was recorded after fixation (T0), immediately postoperatively (T1), on postoperative day 1 (T2), and when the catheter was removed (T3). The change in insertion length from T0 to T3 between the 2 groups was the primary outcome measure. The incidence of catheter failure was also recorded. For all comparisons, P < .05 was considered statistically significant. RESULTS: Initially, 58 women were enrolled; however, 3 patients were excluded. From the remaining 55 patients, 27 and 28 were assigned to the control and treatment groups, respectively, and were evaluated. The change in insertion length from T0 to T3 was significantly more in the control group compared with the treatment group (-1.9 ± 2.2 vs 0 ± 0 cm, respectively; P < .001). In the control group, 11 catheters (41%) failed; in the treatment group, all catheters provided effective analgesia throughout the study (P < .001). CONCLUSIONS: Epidural catheter fixation using film dressing combined with 2-ethyl cyanoacrylate adhesive application at 2 sites along the catheter resulted in secure fixation in patients receiving postoperative epidural analgesia for cesarean delivery.

The Migration of Caudally Threaded Thoracic Epidural Catheters in Neonates and Infants.

BACKGROUND: The migration of pediatric thoracic epidural catheters via a thoracic insertion site has been described. We assessed the migration of caudally threaded thoracic epidural catheters in neonates and infants at our institution. METHODS: The anesthesia records and diagnostic imaging studies of neonates and infants who had caudal epidural catheters placed during a 26-month period at our hospital were analyzed. Imaging studies were reviewed for changes in epidural catheter tip position. RESULTS: Eighty-five patients 1-325 days of age (median, 51 days; interquartile range, 39-78 days) and weights of 2.5-9.5 kg (median, 5 kg; interquartile range, 4.3-5.8 kg) met the study criteria. Fifty-four (64%) of the patients (95% CI, 52%-73%) experienced catheter migration of 1 or more vertebral levels (range, 3 levels caudad [outward] to 3 levels cephalad [inward]), and 23 (27%) of the patients (95% CI, 18%-38%) experienced catheter migration to the T4 level or higher. Migration of 2 or more vertebral levels occurred only in children who weighed <6 kg and were under 73 days of age. CONCLUSIONS: Epidural catheter migration occurs commonly in neonates and infants. Postoperative imaging is crucial to confirm catheter tip location after epidural catheter placement, as failure to assess catheter migration might result in suboptimal analgesia or other undesirable outcomes.

Epidural needle insertion : A large registry analysis.

BACKGROUND: Dural puncture, paraesthesia and vascular puncture are the most common complications of epidural catheter insertion. Their association with variation in midline needle insertion depth is unknown. OBJECTIVE: This study evaluated the risk of dural and vascular punctures and the unwanted events paraesthesia and multiple skin punctures related to midline needle insertion depth. MATERIAL AND METHODS: A total of 14,503 epidural catheter insertions including lumbar (L1-L5; n = 5367), low thoracic (T7-T12, n = 8234) and upper thoracic (T1-T6, n = 902) insertions, were extracted from the German Network for Regional Anaesthesia registry between 2007 and 2015. The primary outcomes were compared with logistic regression and adjusted (adj) for confounders to determine the risk of complications/events. Results are presented as odds ratios (OR, [95% confidence interval]). MAIN RESULTS: Midline insertion depth depended on body mass index, sex, and spinal level. After adjusting for confounders increased puncture depth (cm) remained an independent risk factor for vascular puncture (adjOR 1.27 [1.09-1.47], p = 0.002) and multiple skin punctures (adjOR 1.25 [1.21-1.29], p < 0.001). In contrast, dural punctures occurred at significantly shallower depths (adjOR 0.73 [0.60-0.89], p = 0.002). Paraesthesia was unrelated to insertion depth. Body mass index and sex had no influence on paraesthesia, dural and vascular punctures. Thoracic epidural insertion was associated with a lower risk of vascular puncture than at lumbar sites (adjOR 0.39 [0.18-0.84], p = 0.02). CONCLUSION: Variation in midline insertion depth is an independent risk factor for epidural complications; however, variability precludes use of depth as a reliable guide to insertion in individual patients.