Micro syringe pumps in technology

Fine-Needle EpiduralBlock (FNEB) is less traumatic, easy to operate, and can avoid the tediousness and placement complications of traditional Tuohy needle puncture and placement, and can also accomplish multiple effects of local anesthesia, puncture, drug injection, and Inter-Vertebral Block (IVB) with one needle, and can The FNEB has been widely used in pain clinics because it is easy to displace the puncture needle, has a difficult needle grip, and is easily fatigued [1-3]. In order to prevent the needle tip from shifting into the subdural/subarachnoid space and causing serious complications, some operators tend to slide the needle out of the ligamentum flavum during drug injection, resulting in block failure. For this reason, we replaced the traditional manual drug injection with a microinjection pump in FNEB, aiming to improve the safety and clinical efficacy of FNEB, which is reported below. 1. Data and methods 1.1 General data This was a prospective randomized controlled trial, and patients hospitalized in the pain department of our hospital were selected as study subjects. Inclusion criteria: (1) age above 18 years and below 70 years; (2) ASA classification of grade I-II; (3) clear diagnosis and suitability for FNEB; (4) patients voluntarily accepted FNEB treatment and signed an informed consent form. Exclusion criteria: (1) age below 18 years or above 70 years; (2) contraindication to epidural puncture (mental or psychological disorders, coagulation insufficiency, intradural occupying lesions or spinal cord lesions, and spinal deformities); (3) pregnant or lactating women; (4) combined with severe cardiovascular and cerebrovascular diseases, diabetes mellitus, and hepatic and renal insufficiency; (5) those who punctured or suspected to puncture the dura during fine needle epidural puncture. According to the above criteria, 132 patients were enrolled and randomly divided into microinjection pump group (Group A) and traditional manual group (Group B), with 66 cases in each group. 1.2 Study method 1.2.1 Study appliance Medical syringe pump, model: SDS-MP09 (Beijing Suntex Medical Technology Co., Ltd.); micro-pump extension tube, common type (Zhejiang Yusheng Medical Equipment Co., Ltd.); 22G lumbar puncture needle, specification: 0.7×80mm (Shanghai Essier Medical Instrument Plastic Products Co., Ltd.). 1.2.2 Formulation and course of treatment: The formulation and course of treatment were the same in both groups. Formulation: 2% lidocaine 5ml + vitamin B121mg + vitamin B6100mg + compound betamethasone 1ml + 0.9 sodium chloride injection 10ml; treatment once every two weeks, three times as a course of treatment. 1.2.3 Treatment method Group A: Microinjection pump was used to push the therapeutic drugs (see Figure 1). Method: The assistant aspirated the treatment mixture with a 20 ml syringe and 2 ml of 0.9% sodium chloride solution with a 5 ml syringe and set aside. After successful epidural puncture with a fine needle to confirm that the tip of the needle was located in the epidural space, the assistant connected one end of the extension tube to the mixture syringe, and the other end was connected to the puncture needle by the operator and drained the air, and the syringe was embedded in the syringe holder of the microinjection pump, and the injection rate was set at 180 ml/h (3 ml?min-1). The rest of the drug solution. After the syringe was filled with the mixed drug, the assistant connected the extension tube to the 0.9% sodium chloride syringe. After the lateral approach, the assistant pushes the drug in the extension tube and then the operator pulls out the needle, while in the median approach, the operator slowly withdraws the needle and the assistant pushes the needle under pressure to perform IVB. Group B: traditional manual injection of therapeutic drugs (see Figure 2). Method: The operator used a 20 ml syringe to suck the therapeutic mixture for backup, after successful epidural puncture with a fine needle, the left hand fixed the puncture needle, the right hand received the mixture syringe, slowly injected 5 ml of drug at a speed of 3 ml?min-1 and then paused, observed for 5 min if there was no discomfort, then injected the remaining drug at the original speed, the lateral approach drug pushing was completed and the needle was withdrawn, the median approach was withdrawn when 2 ml of drug was left, that is, while withdrawing the needle and injecting the drug to perform IVB. IVB and pull out the needle, finished bed rest for more than 1h. 1.3 Observation indexes and efficacy assessment The visual analogue scale (VAS) was used to assess the pain level of patients: 0~10 points according to the pain level, with 0 points representing no pain and 10 points representing the most severe pain. Patients in both groups were scored before the first treatment and at the 2-week follow-up after each treatment, and the scores were counted at the last follow-up. The functional assessment was based on the MacNab efficacy assessment criteria: excellent: the symptoms and signs completely disappeared and the original work and life resumed; good: slight symptoms and mild activity restriction, which had no effect on work and life; acceptable: symptoms reduced, activity restriction, which affected normal work and life; poor: no difference before and after treatment, or even worsened. The occurrence of treatment complications/adverse reactions in both groups was also observed. 1.4 Statistical methods The data of this study were statistically processed using SPSS software, and the measurement data were expressed as mean ± standard deviation (X ± SD). The χ2 test was used for the count data, and the t-test was used for the measurement data, with P<0.05 indicating a statistically significant difference. 2. Results Comparison of general data between the two groups A total of 132 patients were enrolled according to the inclusion criteria, and there were no significant differences in the composition of enrolled cases, puncture access, and puncture segments between the two groups; the differences were not statistically significant (P>0.05) when comparing the two groups in terms of gender, age, and weight (see Table 1). Comparison of treatment effects between the two groups All patients in this trial were followed up with scores at 2 weeks after each treatment, and the scores at the last follow-up were counted and compared with the scores before the first treatment. According to the modified MacNab efficacy assessment criteria, the excellent rate in group A reached 95% and the excellent rate in group B was 85%, and the clinical effect in group A was significantly better than that in group B. The difference was statistically significant (P<0.05, see Table 2). Comparison of treatment complications/adverse reactions between the two groups Six cases in group B were found during drug injection in which the puncture needle was displaced and slipped out of the ligamentum flavum and was punctured again; three cases in group B showed symptoms of side effects such as dizziness, tinnitus, labored breathing, and panic discomfort during treatment, and one case in group A and two cases in group B showed similar side effects after treatment, one case in group A and two cases in group B for abnormal plane block, and one case in group B for total spinal anesthesia. The differences were statistically significant when comparing the two groups (P<0.01, see Table 3). 3. Discussion Epidural injection of local anesthetics (LA) and glucocorticoids (GC) can relieve nerve root edema and inflammation [4], and EB has been a non-surgical treatment for chronic pain because the drugs reach the lesion directly and can relieve or treat pain efficiently and rapidly. important tool and one of the most classic NB techniques in pain medicine. Since most chronic pain diseases need to receive EB several times in a certain treatment cycle, in order to reduce medical puncture injuries, decrease the incidence of PPLBP, and avoid the tediousness and complications of traditional Tuohy puncture placement, in recent years, 22G (7#) and 20G (8#) lumbar puncture needles are commonly used in pain clinics instead of 18# and 16# epidural puncture needles to perform epidural gap puncture and inject therapeutic drugs into the The epidural space is injected with therapeutic drugs to achieve EB or minimally invasive ablation of the intervertebral disc. FNEB was originally evolved from “IVB” proposed by Yan Xiangmo in 1980 [5], and the puncture method of both is basically the same, with the difference that IVB puncture can enter the interspinous space and reach the ligamentum flavum, while FNEB requires breaking through the ligamentum flavum to enter the epidural space; later, according to Song Wenge et al [6] “Study of epidural lateral saphenous fossa puncture” provided a theoretical basis for the lateral entry puncture route of FNEB, in which the puncture needle reaches the lateral space/lateral saphenous fossa directly, allowing the drug to reach the inflammatory lesion directly and focus on the diseased nerve root, or injecting collagenase/medicalozone (O3) directly into the herniated disc. directly into the herniated disc [7], for FNEB and injectable collagenase/O3 extradiscal injections, and also for PulsedRadioFrequency (PRF) treatment [8]. In view of the possibility of inadvertent entry into the subarachnoid space and serious complications such as chemical encephalomyelitis, paraplegia and even death associated with lateral crypt injections with injectable collagenase or O3 [9-11], the lateral entry route in this study was only used for conventional FNEB. The key to traditional manual drug injection in FNEB is to hold the puncture needle firmly to prevent displacement, for which the operator must maintain a fixed injection position for more than 10 minutes, and there are problems with holding In order to prevent the needle tip from shifting into the subdural space/subarachnoid space and causing serious complications, some operators tend to slide the needle out of the ligamentum flavum during drug injection, resulting in block failure, and if the needle slips out of the ligamentum flavum and then punctures the epidural space, the risk of puncturing the dura mater is bound to increase. In addition, the speed of traditional manual drug injection is not easy to control, and the drug is injected too fast or too slow to cause treatment complications/adverse reactions. Microinjection pumps are used to inject drugs with precise dose, constant speed, convenient operation and continuous infusion [12], and are mostly used for intravenous pumping or continuous epidural pumping in clinical practice [13-15]. In this study, the microinjection pump was used to inject drugs into FNEB and controlled with traditional manual drug injection, and the results of the study showed that the excellent rate in group A was significantly higher than that in group B, and the incidence of complications/adverse reactions in group A was also significantly lower than that in group B, which effectively improved the clinical efficacy and treatment safety. The main advantages include: (1) saving labor, the operator does not need to maintain a fixed injection position for a long time; (2) avoiding needle tip displacement during injection to ensure treatment safety and improve clinical efficacy; (3) smooth and controlled injection speed, effectively reducing complications/adverse reactions caused by uneven injection speed. In summary, the microinjection pump for FNEB is convenient, smooth and controllable, and can pump the drug into the epidural space precisely and uniformly, which can not only avoid its shortcomings but also significantly improve clinical efficacy and treatment safety compared with traditional manual drug injection. The microinjection pump for FNEB, as a technological innovation, has not been publicly reported at home and abroad before, and the data of this study come from a single hospital, which has limitations, and its clinical application research needs to be further improved by more sample and multicenter experimental studies.