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541 result(s) for "Spinal Puncture - methods"
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Changing the needle for lumbar punctures: results from a prospective study
Post-dural puncture headache (PDPH) is a common complication of diagnostic lumbar punctures. Both a non-cutting needle design and the use of smaller size needles have been shown to greatly reduce the risk of PDPH. Nevertheless, larger cutting needles are still widely used. This study describes the process of changing the needle in an outpatient clinic of a Danish neurology department. Prospective interventional trial. Phase 1: 22G cutting needle. Phase 2: 25G non-cutting needle. Practical usability of each needle was recorded during the procedure, while the rate of PDPH and the occurrence of socioeconomic complications were acquired from a standardized questionnaire. 651 patients scheduled for diagnostic lumbar punctures were screened for participation and 501 patients were included. The response rate was 80% in both phases. In phase 2, significant reductions were observed in occurrence of PDPH (21 vs. 50, p=0.001), number of days spent away from work (55 vs. 175, p<0.001), hospitalizations (2 vs. 17, p<0.001), and number of bloodpatch treatments (2 vs. 10, p=0.019). Furthermore, during the procedure, both the need for multiple attempts (30% vs. 44%, p=0.001), and the failure-rate of the first operator (17% vs. 29%, p=0.005) were reduced. Our study showed that smaller, non-cutting needles reduce the incidence of PDPH and are easily implemented in an outpatient clinic. Changing the needle resulted in fewer socioeconomic complications and fewer overall costs, while also reducing procedural difficulty.
Ultrasonography versus palpation for spinal anesthesia in obese parturients undergoing cesarean delivery: a randomized controlled trial
IntroductionUltrasonography may facilitate neuraxial blocks in obstetrics. This randomized controlled trial aimed to compare preprocedural ultrasonography with landmark palpation for spinal anesthesia in obese parturients undergoing cesarean delivery.Methods280 American Society of Anesthesiologists (ASA) physical status II–III parturients with body mass index ≥35 kg/m2, full-term singleton pregnancy, undergoing elective cesarean delivery under spinal anesthesia, were randomly assigned to two equal groups (ultrasonography and palpation); preprocedural systematic ultrasound approach and conventional landmark palpation were performed, respectively. Patients and outcome assessors were blinded to the study group. All ultrasound and spinal anesthetic procedures were performed by a single experienced anesthesiologist. The primary outcome was the number of needle passes required to obtain free cerebrospinal fluid (CSF) flow. Secondary outcomes were the number of skin punctures required to obtain free CSF flow, success rate at the first needle pass, success rate at the first skin puncture, duration of the spinal procedure, patient satisfaction and incidence of vascular puncture, paresthesia, failure to obtain CSF flow and failed spinal block.ResultsThere were no significant differences in primary or secondary outcomes between the two groups. The median (IQR) of the number of needle passes required to obtain free CSF flow was 3 (1–7) in ultrasonography group and 3 (1–7) in palpation group; p=0.62.ConclusionsPreprocedural ultrasonography did not decrease the number of needle passes required to obtain free CSF flow or improve other outcomes compared with landmark palpation during spinal anesthesia performed by a single experienced anesthesiologist in obese parturients undergoing cesarean delivery.Trial registration numberNCT03792191; https://clinicaltrials.gov/ct2/show/NCT03792191
Comparison of the dural puncture epidural and the standard epidural techniques in patients having labor analgesia maintained using programmed epidural boluses: a prospective double-blinded randomized clinical trial
BackgroundThe dural puncture epidural technique has been shown in some studies to improve the onset and quality of the initiation of labor analgesia compared with the standard epidural technique. However, few studies have investigated whether this technique confers advantages during the maintenance of analgesia. This randomized double-blinded controlled study compared dural puncture epidural analgesia with standard epidural analgesia when analgesia was maintained using programmed intermittent epidural boluses.Methods400 parturients requesting epidural labor analgesia were randomized to have analgesia initiated with a test dose of 3 mL lidocaine 1.5% with epinephrine 15 µg, followed by 12 mL ropivacaine 0.15% mixed with sufentanil 0.5 µg/mL using the dural puncture epidural or the standard epidural technique. After confirming satisfactory analgesia, analgesia was maintained with ropivacaine 0.1% and sufentanil 0.5 µg/mL via programmed intermittent epidural boluses (fixed volume 8 mL, intervals 40 min). We compared local anesthetic consumption, pain scores, obstetric and neonatal outcomes and patient satisfaction.ResultsA total of 339 patients completed the study and had data analyzed. There were no differences between the dural puncture epidural and standard epidural groups in ropivacaine consumption (mean difference −0.724 mg, 95% CI of difference −1.450 to 0.001 mg, p=0.051), pain scores, time to first programmed intermittent epidural bolus, the number of programmed intermittent epidural boluses, the number of manual epidural boluses, obstetric outcome or neonatal outcome. Patient satisfaction scores were statistically higher in the dural puncture epidural group but the absolute difference in scores was small.ConclusionOur findings suggest that when labor analgesia is maintained using the programmed intermittent epidural bolus method, there is no significant advantage to initiating analgesia using the dural puncture epidural compared with the standard epidural technique.Trial registration numberChiCTR2200062349.
Advancing medical training with augmented reality and haptic feedback simulator: outcomes of a randomized controlled trial on lumbar puncture
Background Lumbar puncture (LP) procedure can be challenging, creating stress for both patients and students. This study assesses the effectiveness of augmented reality (AR) and haptic feedback simulation training compared to traditional bedside teaching. Method We conducted a prospective, single center, randomized controlled clinical trial with two parallel groups of medical students inexperienced in LP. Students were randomized to either the simulation group or the control group receiving traditional bedside teaching. Patients requiring LPs as part of their routine care were randomized. The primary outcome was LP success rate. Secondary outcomes included procedure duration, complication rates and patient and student perceptions. Results The study included 55 patients (AR group: n  = 29; control group: n  = 26). LP success rates were similar between groups (AR: 46.4%, control: 40.0%; p  = 0.9). Median procedure duration was shorter in the AR group (138 s [IQR 37–454]) compared to the control group (695 s [IQR 15–900]), though not statistically significant ( p  = 0.67). Patient pain and anxiety scores did not differ significantly, but patients reported greater ease and higher satisfaction with simulator-trained students. Students in the AR group expressed greater comfort performing the procedure (7/10 vs. 6/10; p  = 0.04). Complication rates were low and comparable across groups. Conclusion Although augmented reality simulation training did not improve LP success rate, it improved the procedural speed and student ease without compromising technical performance. Patients preferred to be handled by simulator-trained students. These findings support the integration of AR technologies in medical training to improve efficiency and relational skills. ClinicalTrials.gov ID NCT05269238, Registration Date 2022-01-14.
Dural puncture epidural technique with 23-, 25- or 27-gauge pencil point spinal needles versus standard epidural technique for labor analgesia: a randomized trial
Background Dural puncture epidural (DPE) improves labor analgesia by reducing numeric rating scale (NRS) score, accelerating onset, and enhancing sacral blockade. Although larger-gauge needles may potentiate local anesthetic diffusion and improve analgesic quality, current clinical practice favors smaller-gauge needles (25-gauge to 27-gauge) to mitigate post-dural puncture headache (PDPH) risks. This randomized trial specifically evaluates the differential impacts of 23-gauge, 25-gauge, and 27-gauge needles on both analgesic efficacy and procedure-related complications. Methods In this randomized trial, 200 parturients requesting labor analgesia received DPE (23-gauge, 25-gauge, 27-gauge subgroups) or standard epidural (EP), followed by programmed intermittent epidural boluses (PIEB) of 12 mL with ropivacaine 0.08% and sufentanil 0.33 µg/mL every 50 min. Primary outcome was NRS score 10 min after the initial epidural bolus; secondary outcomes included time to NRS score ≤ 1, block characteristics at 20 min, number of top-up boluses, Apgar scores, and adverse events. Results Among 198 analyzed participants, all DPE groups exhibited lower 10-minute NRS scores versus EP groups ( P  < 0.001). The 23-gauge and 25-gauge subgroups had lower NRS scores than 27-gauge ( P  < 0.05), with no difference between 23-gauge and 25-gauge ( P  > 0.05). The 23-gauge group achieved NRS score ≤ 1 fastest ( P  < 0.001). DPE groups demonstrated higher bilateral sacral (S2) blockade rates versus EP groups ( P  < 0.001), with no inter-subgroup differences. No significant difference were observed in procedure duration, top-up requirements, catheter adjustments/replacement, complications (PDPH, hypotension, nausea), or neonatal Apgar scores at 1 and 5 min. Conclusion Compared to conventional epidural analgesia, the combined application of DPE and PIEB techniques demonstrated superior quality. The utilization of 25-gauge pencil-point spinal needles achieves the optimal balance between analgesic efficacy and safety, while the 23-gauge needle may be suitable for specific scenarios requiring rapid onset of action.
Mixed reality-assisted versus landmark-guided spinal puncture in elderly patients: protocol for a stratified randomized controlled trial
Background Performing spinal anesthesia in elderly patients with spine degeneration is challenging for novice practitioners. This stratified randomized controlled trial aims to compare the effectiveness of mixed reality-assisted spinal puncture (MRasp) with that of landmark-guided spinal puncture (LGsp) performed by novice practitioners in elderly patients. Methods This prospective, single-center, stratified, blocked, parallel randomized controlled trial will include 168 patients (aged ≥ 65 years) scheduled for elective surgery involving spinal anesthesia. All spinal punctures will be performed by anesthesiology interns and residents trained at Huadong Hospital. Patients will be randomly assigned to the MRasp group ( n  = 84) or the LGsp group ( n  = 84). Based on each intern/resident’s experience in spinal puncture, participants will be stratified into three clusters: the primary group, intermediate group, and advanced group. The primary outcome will be the comparison of the rate of successful first-attempt needle insertion between the MRasp group and the LGsp group. Secondary outcomes will include the number of needle insertion attempts, the number of redirection attempts, the number of passes, the rate of successful first needle pass, the spinal puncture time, the total procedure time, and the incidence of perioperative complications. A stratified subgroup analysis will also be conducted for interns/residents at different experience levels. Discussion The findings from this trial establish the effectiveness of MRasp by novice practitioners in elderly patients. This trial may provide experimental evidence for exploring an effective visualization technology to assist in spinal puncture. Trial registration Chinese Clinical Trials Registry ChiCTR2300075291. Registered on August 31, 2023. https://www.chictr.org.cn/bin/project/edit?pid=189622 .
Success and complications in lumbar punctures of pediatric patients with leukemia: a study protocol for a randomized clinical crossover trial of a bioimpedance needle system versus conventional procedure
Background Acute lymphoblastic leukemia (ALL) is the most common malignancy diagnosed in children. At present, the long-term survival from pediatric ALL is well over 90%. However, the probability of event-free survival is reduced if the lumbar puncture (LP) procedures at the beginning of the patient’s intrathecal therapy cause blood leakage into the spinal canal and blast cells contaminate the cerebrospinal fluid. According to the literature, such traumatic LP procedures concern one out of five pediatric patients with ALL. Recently, a novel medical device measuring the tissue bioimpedance at the tip of a spinal needle was found feasible in pediatric patients with ALL. The LP procedure was successful at the first attempt in 80% of procedures, and the incidence of traumatic LPs was then 11%. The purpose of the present study is to compare the bioimpedance spinal needle system with the standard clinical practice resting on a conventional spinal needle and investigate its efficacy in clinical practice. Methods The study is a multicenter, randomized, two-arm crossover noninferiority trial of pediatric hemato-oncology patients that will be conducted within the usual clinical workflow. Patients’ LP procedures will be performed alternately either with the IQ-Tip system (study arm A) or a conventional Quincke-type 22G spinal needle (study arm B). For each enrolled patient, the order of procedures is randomly assigned either as ABAB or BABA. The total number of LP procedures will be at least 300, and the number of procedures per patient between two and four. After each study LP procedure, the performance will be recorded immediately, and 1-week diary-based and 4-week record-based follow-ups on symptoms, complications, and adverse events will be conducted thereafter. The main outcomes are the incidence of traumatic LP, first puncture success rate, and incidence of post-dural puncture headache. Discussion The present study will provide sound scientific evidence on the clinical benefit, performance, and safety of the novel bioimpedance spinal needle compared with the standard clinical practice of using conventional spinal needles in the LP procedures of pediatric patients with leukemia. Trial registration ISRCTN ISRCTN16161453. Registered on 8 July 2022.
Comparison of accuracy between augmented reality/mixed reality techniques and conventional techniques for epidural anesthesia using a practice phantom model kit
Background This study used an epidural anesthesia practice kit (model) to evaluate the accuracy of epidural anesthesia using standard techniques (blind) and augmented/mixed reality technology and whether visualization using augmented/mixed reality technology would facilitate epidural anesthesia. Methods This study was conducted at the Yamagata University Hospital (Yamagata, Japan) between February and June 2022. Thirty medical students with no experience in epidural anesthesia were randomly divided into augmented reality (-), augmented reality (+), and semi-augmented reality groups, with 10 students in each group. Epidural anesthesia was performed using the paramedian approach with an epidural anesthesia practice kit. The augmented reality (-) group performed epidural anesthesia without HoloLens2Ⓡ and the augmented reality (+) group with HoloLens2Ⓡ. The semi-augmented reality group performed epidural anesthesia without HoloLens2Ⓡ after 30 s of image construction of the spine using HoloLens2Ⓡ. The epidural space puncture point distance between the ideal insertion needle and participant’s insertion needle was compared. Results Four medical students in the augmented reality (-), zero in the augmented reality (+), and one in the semi-augmented reality groups failed to insert the needle into the epidural space. The epidural space puncture point distance for the augmented reality (-), augmented reality (+), and semi-augmented reality groups were 8.7 (5.7–14.3) mm, 3.5 (1.8–8.0) mm (P = 0.017), and 4.9 (3.2–5.9) mm (P = 0.027), respectively; a significant difference was observed between the two groups. Conclusions Augmented/mixed reality technology has the potential to contribute significantly to the improvement of epidural anesthesia techniques.
Ultrasound-guided lumbar puncture with a needle-guidance system: A prospective and controlled study to evaluate the learnability and feasibility of a newly developed approach
To evaluate the learnability and feasibility of a new technique comprising a needle-guidance-system (NGS) for ultrasound-assisted lumbar puncture. Using a randomized crossover study design, 24 medical students were asked to perform an ultrasound-assisted lumbar puncture on a gel phantom using two different techniques that each included a paramedian insertion site. Procedure 1 (P1) used a pre-procedural ultrasound scan to predetermine the ideal insertion point. Procedure 2 (P2) applied a new technique comprising an NGS for performing real-time ultrasound-guided lumbar puncture. Success rates and performance times for both procedures were compared. Participants were also asked to complete a post-study questionnaire, both to quantitatively assess the workload involved and state their personal preferences. In comparison to the pre-procedural scan (P1), the NGS (P2) was associated with a significant increase in the number of successful punctures per participant (5 (P2) [interquartile range: 3.3-5.0] vs. 3 (P1) [interquartile range: 1.3-4.0], p = 0.005), and led to a significant reduction in performance time (118 seconds vs. 80.6 seconds, p < 0.001). In terms of workload perception, NGS use was associated with significantly better performances and lower frustration levels, as rated by students in the post-study questionnaire. Finally, 23/24 participants stated their preference for P2. Our newly-developed technique for real-time ultrasound-guided lumbar puncture proved to be learnable and feasible for novices, and only required a small amount of training. The use of an NGS therefore has the potential to serve as a key feature of the ultrasound-assisted lumbar puncture.
Comparison of the incidence of fetal prolonged deceleration after induction of labor analgesia between dural puncture epidural and combined spinal epidural technique: a pilot study
Background Abnormal cardiotocogram (CTG) tracing may appear after induction of neuraxial labor analgesia. Non-reassuring fetal status (NRFS) indicated by severely abnormal tracings, such as prolonged deceleration (PD) or bradycardia, can necessitate immediate operative delivery. Combined spinal epidural analgesia (CSEA) is known to result in more frequent abnormal tracings than epidural analgesia (EA); however, the corresponding data related to dural puncture epidural (DPE) are unclear. We aimed to evaluate the rates of incidence of severe abnormal CTG after induction of DPE and CSEA. Methods In this study of nulliparous women with full-term pregnancy, data for the DPE intervention group were prospectively collected, while those for the CSEA control group were obtained from medical records. Neuraxial analgesia was performed with cervical dilation ≤ 5 cm, administering initial epidural dosing of 15 mL of 0.125% levobupivacaine with fentanyl 2.5µg/mL for DPE, and intrathecal 0.5% bupivacaine 2.5 mg (0.5ml), fentanyl 10 µg (0.2ml), and 1.3 mL of saline for CSEA. The primary outcome was the incidence of PD, defined as a fetal heart rate reduction ≥ 15 bpm below the baseline and with a lowest value < 80 bpm, and lasting for ≥ 2 min but < 10 min (fetal heart rate < 80 bpm does not have to last for ≥ 2 min), within 90 min after induction of neuraxial labor analgesia. Results A total of 302 patients were analyzed, with 151 in each group. The incidence of PD after DPE induction was significantly lower than that after CSEA induction (4.0% vs. 14.6%, P  = 0.0015, odds ratio = 0.243, 95% confidence interval = 0.095–0.617). Conclusion DPE appears to be a safer method compared to CSEA for neuraxial labor analgesia in the early stages of labor for nulliparous women. Trial registration UMIN-CTR: UMIN000035153 . Date registered: 01/01/2019.