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Objective@#To evaluate the clinical efficacy of Compound Chamomile and Lidocaine Hydrochloride Gel for postoperative hypospadias in children.@*METHODS@#From January to December 2020, we treated 116 children with distal hypospadias in the Department of Urology, Department of Pediatrics and the Seventh Medical Center of the PLA General Hospital, 58 by primary Snodgrass urethroplasty only (the control group) and the other 58 with Compound Chamomile and Lidocaine Hydrochloride Gel smeared on the penis postoperatively in addition (the trial group). We compared the operation time and postoperative pain score, edema regression and incidence of infection between the two groups, followed by statistical analysis using T test and Chi-square test.@*RESULTS@#All the operations were successfully completed by the same surgeon under general anesthesia. There were no statistically significant differences between the trial and control groups in age (［2.5 ± 0.8］ vs ［2.4 ± 0.6］ yr, P > 0.05) or operation time (［95.6 ± 14.5］ vs ［97.1 ± 15.2］ min, P > 0.05). No incision infection occurred in any of the cases. The pain scores at dressing removal were remarkably lower in the trial than in the control group at 2 hours (1.4 ± 1.0 vs 2.6 ± 1.3, P < 0.05), 24 hours (2.2 ± 1.3 vs 3.9 ± 1.6, P < 0.05), 48 hours (1.2 ± 0.7 vs 1.6 ± 0.9, P < 0.05) and 72 hours after surgery (2.5 ± 0.8 vs 3.7 ± 1.8, P < 0.05). Significantly more cases of edema regression were achieved in the trial than in the control group at 2 weeks postoperatively (35 vs 19, P < 0.05).@*CONCLUSIONS@#Compound Chamomile and Lidocaine Hydrochloride Gel can effectively relieve pain, reduce edema and accelerate edema regression after surgery in children with hypospadias, and therefore deserves wide clinical application.、.
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Child, Preschool , Humans , Male , Chamomile , Hypospadias/surgery , Lidocaine/therapeutic use , Pain, Postoperative/drug therapy , Postoperative PeriodABSTRACT
@#2,6-dimethylbenzenamine was determined as a genotoxic impurity in lidocaine hydrochloride injection, and 2-chloro-N-(2,6- dimethylphenyl) acetamide was determined as potential genotoxic impurity. An LC-MS/MS method was established to research the profiling of genotoxic impurities in active pharmaceutical ingredients (API), homemade preparation and reference preparation on column Agilent ZORBAX Eclipse Plus C18(4.6 mm250 mm，5 μm). The results show that in the homemade preparation the 2,6-dimethylbenzenamine and the 2-chloro-N-(2,6-dimethylphenyl) acetamide may be degraded under oxidation condition and alkaline condition in addition to the introduction from API preparation process. This study provides guidance for genotoxic risk assessment and prescription process optimization of lidocaine hydrochloride.
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Two percent lidocaine hydrochloride is the gold standard for dental anesthesia against which newer local anesthetic agents may be compared. 0.75% ropivacaine is a newer, long-acting amide local anesthetic agent with inherent vasoconstriction property. Aim: This study aims to compare the efficacy of 0.75% ropivacaine and 2% lidocaine hydrochloride with 1:200,000 adrenaline in pain control in extraction of mandibular posterior teeth. Settings and Design: This is a prospective, double-blind, and split-mouth study. Subjects and Methods: Twenty patients were divided into two groups according to the right and left sides of patient – side A and side B. The side, where 0.75% ropivacaine was to be administered, was randomly selected by flip coin method. Then, the pterygomandibular and long buccal nerve blocks were administered with 0.75% ropivacaine and necessary dental extraction was performed. After 1 week, the same procedure was repeated using 2% lidocaine hydrochloride with 1:200,000 adrenaline. The parameters assessed were pain on injection, onset of anesthesia, pain during the extraction, and duration of anesthesia. Statistical Analysis Used: The nonparametric data were assessed by Mann Whitney “U” test. Results: The mean onset of action for solution A was 7.15 ± 4.934 min and for solution B was 9.75±5.128 min. This was statistically significant. The mean duration of action, pain on injection, and pain during extraction were not significant. Conclusion: This study clearly states that there is no clear advantage of using 0.75% ropivacaine in pterygomandibular nerve block over the gold standard. However, more clinical studies with larger sample size are necessary.
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Objective To compare the anesthetic effect of atocaine adrenaline injection and lidocaine injec -tion in wisdom tooth extraction .Methods 220 patients with wisdom teeth were selected as the research subjects . According to the random table method ,the patients were randomly divided into research group 110 cases ( a total of wisdom teeth 132,maxillary wisdom teeth 47,mandibular wisdom tooth 85) and the control group 110 cases(a total of wisdom teeth 129,maxillary wisdom teeth 51,mandibular wisdom tooth 78).The research group received atocaine adrenaline injection ,the control group received lidocaine hydrochloride injection .The effects of anesthesia ,VAS score and adverse reactions in the two groups were observed .Results The total effective rate of maxillary wisdom tooth anesthesia in the research group(100.00％) was significantly higher than that in the control group (90.20％),and the difference between the two groups was statistically significant (χ2 =6.358,P<0.05).The total effective rate of mandibular wisdom tooth anesthesia in the research group (100.00％) was significantly higher than that in the control group(92.31％),and the difference between the two groups was statistically significant (χ2 =6.788,P<0.05).The VAS score of maxillary wisdom tooth anesthesia in the research group [(2.57 ±0.65)points]was significantly lower than that in the control group [(2.87 ±0.63) points],and the difference between the two groups was statistically significant(t=2.319,P<0.05).In the control group,there was 1 case of hematoma caused by blood vessels ,and no complications occurred in the research group .Conclusion The anesthetic effects of articaine adrenaline injection in wisdom tooth extraction is better than lidocaine hydrochloride injection , without any complications , it is worthy of clinical promotion .
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Microneedles is an efficient, safe and novel transdermal drug delivery technology that has attracted much attention in recent decades. Microneedles could break through the skin's stratum corneum barrier and have an especially significant effect on the transdermal delivery of water-soluble small molecules and biological macromolecules. In this paper, a rapid onset local anesthetic preparation of lidocaine hydrochloride was prepared based on dissolving microneedles, and related quality evaluations were carried out. The key quality indicators of prepared lidocaine hydrochloride dissolving microneedles such as drug loading amount, appearance morphology, mechanical properties, skin penetration performance, in vitro dissolution performance and local anesthetic efficacy were investigated with HPLC, SEM, texture analyzer, organic staining, histological section, in vitro dissolution test and pharmacodynamics experiments respectively. The drug loading of the dissolving microneedles array reached 68.19 ±1.55 mg, and the needle tip contained 3.57 ±0.21 mg. The microneedles has good needle shape and sufficient mechanical strength to penetrate into the skin, which is a prerequisite for the successful administration of the preparation. The in vitro dissolution time was 28.28 ±1.12 s. When applied to guinea pig back acupuncture model which was modified by guinea pig intradermal papules model, although the efficacy maintenance time was shorter than that of compound lidocaine cream, dissolving microneedles can be activated within 1 min, which was much faster than compound lidocaine cream. It is possible to increase the duration of drug efficacy by increasing the density of microneedles and preparing microneedles for sustained and controlled release in future studies. Lidocaine hydrochloride dissolving microneedles and its evaluation methods for local anesthesia were established systematically here for the first time. The rapid effect of anesthesia with lidocaine hydrochloride dissolving microneedles on the skin was worthy of further investigation.
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Objective:To evaluate the analgesic effects of two kinds of preoperative peripheral nerve block drug in patients with tri-geminal neuralgia undergoing radiofrequency thermocoagulation(RFT)of gasserian ganglion.Methods:90 patients with classic trigemi-nal neuralgia of the 3rd branch were scheduled to undergo RFT of the gasserian ganglion and were randomly divided into 3 groups(n =30).The patients in group N without nerve block were served as the controls.The patients in group A and B were treated by the nerve block of inferior alveloar with 2 ml of 2% lidocaine hydrochloride and 2 ml of compound lidocaine hydrochloride for each respectively 2 d before RFT.The pain control was studied by VAS method before and 24,48 h after nerve blocking and during pucture for RFT.Re-sults:Compared with the control group,24 h after nerve blocking,the average pain and the most pain VAS value of group A and B were significantly reduced(P <0.01);sleep quality and analgesia satisfaction were improved in group A and B(P <0.05).48 h after nerve blocking the pain relief and sleep quality improvement of group B were more than those of group A(P <0.05).In addition,during RFT puncture the pain intensity of group A and B were less than that of group N(P <0.05).The pain control in group B was more effective than that in group A.Conclusion:A single peripheral nerve block with long-term narcotic compound lidocaine hydrochloride can be an effective way to relieve preoperative and operative pain for RFT of trigeminal neuralgia.
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Objective To improve the quality control standard of lidocaine hydrochloride injection .Methods A method for determination of related substances in lidocaine hydrochloride injection was established .Lidocaine hydrochloride was as‐sayed by HPLC .The chromatographic conditions :C18 chromatographic column was used .The mobile phase was phosphate buffer and acetonitrile (50∶50 ,adjusted to pH 8 with phosphoric acid) .The detection wavelength was 254 nm .Results Ac‐cording to the result of method verification ,related substances could be examined by HPLC .Lidocaine hydrochloride was as‐sayed by HPLC ,which showed excellent linearity at the range of 373 .62‐3 736 .19 μg/ml .The average recoveries were 102 .1% (RSD=0 .9% ) .Conclusion The improved standard could be used to control the quality of lidocaine hydrochloride injection .
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Objective To analyse the pain analgesic efficacy and safety evaluation of diclofenac sodium and lidocaine hydrochloride combined with anisodamine in patients with bone fractures.Methods 54 patients who were diagnosed with acute fracture in the hospital were collected and randomly divided into experimental group and control group, 27 cases in each group, control group was treated with diclofenac sodium and lidocaine hydrochloride, and experimental group was treated with anisodamine on the basis of control group.Before 30 min and 2 h after treatment, the effect of 5-hydroxytryptamine ( 5-HT ), prostaglandin E2 ( PGE2 ), analgesic effect, tolerability and adverse reactions were detected in all patients. ResuIts Compared with control group post treatment, the plasma 5-HT content was significantly lower in experimental group ( P<0.05 ); the plasma PGE2 content in experimental group was significantly lower (P<0.05); the pain rating index (PRI) total score,PRI feel score, PRI emotion score, present pain intensity (PPI) and visual analogue scale (VAS) in experimental group was significantly lower (P<0.05).The tolerance of experimental group was 92.59%, which was significantly higher than 66.67% of control group (χ2 =5.59,P<0.05).ConcIusion Diclofenac sodium and lidocaine hydrochloride combined with anisodamine could significantly decrease 5-HT and PGE2 in patients with fracture pain, enhance the analgesic effect, reduce the incidence of adverse reactions, with a good tolerance, which have the guiding significance on clinical therapy.
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BACKGROUND: There have been few studies on the effect of an elevated concentration of lidocaine hydrochloride in the surgical removal of an impacted lower third molar. This study aimed to examine the efficacy of 4% lidocaine along with 1:100,000 epinephrine compared to 2% lidocaine along with 1:100,000 epinephrine as inferior alveolar nerve block for the removal of an impacted lower third molar. METHODS: This single-blind study involved 31 healthy patients (mean age: 23 y; range: 19-33 y) with symmetrically impacted lower third molars as observed on panoramic radiographs. Volunteers required 2 surgical interventions by the same surgeon with a 3-week washout period. The volunteers were assigned either 4% lidocaine with 1:100,000 epinephrine or 2% lidocaine with 1:100,000 epinephrine as local anesthetic during each operation. RESULTS: We recorded the time of administration, need for additional anesthetic administration, total volume of anesthetic used. We found that the patient's preference for either of the 2 types of local anesthetic were significantly different (P < 0.05). However, the extent of pulpal anesthesia, surgical duration, and duration of soft tissue anesthesia were not significantly different. CONCLUSIONS: Our study suggested that inferior alveolar nerve block using 4% lidocaine HCl with 1:100,000 epinephrine as a local anesthetic was clinically more effective than that using 2% lidocaine HCl with 1:100,000 epinephrine; the surgical duration was not affected, and no clinically adverse effects were encountered.
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Humans , Anesthesia , Epinephrine , Lidocaine , Mandibular Nerve , Molar, Third , Single-Blind Method , VolunteersABSTRACT
Objective:To establish a method to determine the content of lidocaine hydrochloride in buccal adhesive tablets contai-ning carbomer as an excipient by HPLC. Methods:Calcium chloride was used to precipitate carbomer in buccal adhesive tablets. The HPLC analysis was performed on a Welch C18 column(250 mm × 4. 6 mm,5 μm)with the column temperature of 40℃. The mobile phase was the mixture of 0. 05% sodium acetate solution(added 50 ml acetic acid into 930 ml distilled water,adjusting pH to 3. 40 with 1 ml·min-1 sodium hydroxide solution)and acetonitrile(70:30). The flow rate was 1. 0 ml·min-1 ,the detection wavelength was at 254 nm and the injection volume was 20 μl. Results:Within the range of 0. 10-2. 00 mg·ml-1 ,there was a good linear rela-tionship between the concentration and the peak area of lidocaine hydrochloride(r=0. 999 9). The average recovery was 100. 2%( RSD=1. 4%,n=9). Conclusion:The established method is simple,accurate and reproducible,which can be applied to determine the content of lidocaine hydrochloride in buccal adhesive tablets.
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BACKGROUND: The authors studied the hemodynamic effect influent by using the novel high concentration of lidocaine HCl for surgical removal impacted lower third molar. The objective of this study was to evaluate the hemodynamic change when using different concentrations of lidocaine in impacted lower third molar surgery. METHODS: Split mouth single blind study comprising 31 healthy patients with a mean age of 23 years (range 19-33 years). Subjects had symmetrically impacted lower third molars as observed on panoramic radiograph. Each participant required 2 surgical interventions by the same surgeon with a 3-week washout period washout period. The participants were alternately assigned one of two types of local anesthetic (left or right) for the first surgery, then the other type of anesthetic for the second surgery. One solution was 4% lidocaine with 1:100,000 epinephrine and the other was 2% lidocaine with 1:100,000 epinephrine. A standard IANB with 1.8 ml volume was used. Any requirement for additional anesthetic and patient pain intra-operation was recorded. Post-operatively, patient was instructed to fill in the patient report form for any adverse effect and local anesthetic preference in terms of intra-operative pain. This form was collected at the seven day follow up appointment. RESULTS: In the 4% lidocaine group, the heart rate increased during the first minute post-injection (P < 0.05). However, there was no significant change in arterial blood pressure during the operation. In the 2% lidocaine group, there was a significant increase in arterial blood pressure and heart rate in the first minute following injection for every procedure. When the hemodynamic changes in each group were compared, the 4% lidocaine group had significantly lower arterial blood pressure compared to the 2% lidocaine group following injection. Post-operatively, no adverse effects were observed by the operator and patient in either local anesthetic group. Patients reported less pain intra-operation in the 4% lidocaine group compared with the 2% lidocaine group (P < .05). CONCLUSIONS: Our results suggest that a 4% concentration of lidocaine HCl with 1:100,000 epinephrine has better clinical efficacy than 2% lidocaine HCl with 1:100,000 epinephrine when used for surgical extraction of lower third molars. Neither drug had any clinical adverse effects.
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Humans , Arterial Pressure , Epinephrine , Follow-Up Studies , Heart Rate , Hemodynamics , Lidocaine , Molar, Third , Mouth , Single-Blind Method , Treatment OutcomeABSTRACT
BACKGROUND: The authors studied the hemodynamic effect influent by using the novel high concentration of lidocaine HCl for surgical removal impacted lower third molar. The objective of this study was to evaluate the hemodynamic change when using different concentrations of lidocaine in impacted lower third molar surgery. METHODS: Split mouth single blind study comprising 31 healthy patients with a mean age of 23 years (range 19-33 years). Subjects had symmetrically impacted lower third molars as observed on panoramic radiograph. Each participant required 2 surgical interventions by the same surgeon with a 3-week washout period washout period. The participants were alternately assigned one of two types of local anesthetic (left or right) for the first surgery, then the other type of anesthetic for the second surgery. One solution was 4% lidocaine with 1:100,000 epinephrine and the other was 2% lidocaine with 1:100,000 epinephrine. A standard IANB with 1.8 ml volume was used. Any requirement for additional anesthetic and patient pain intra-operation was recorded. Post-operatively, patient was instructed to fill in the patient report form for any adverse effect and local anesthetic preference in terms of intra-operative pain. This form was collected at the seven day follow up appointment. RESULTS: In the 4% lidocaine group, the heart rate increased during the first minute post-injection (P < 0.05). However, there was no significant change in arterial blood pressure during the operation. In the 2% lidocaine group, there was a significant increase in arterial blood pressure and heart rate in the first minute following injection for every procedure. When the hemodynamic changes in each group were compared, the 4% lidocaine group had significantly lower arterial blood pressure compared to the 2% lidocaine group following injection. Post-operatively, no adverse effects were observed by the operator and patient in either local anesthetic group. Patients reported less pain intra-operation in the 4% lidocaine group compared with the 2% lidocaine group (P < .05). CONCLUSIONS: Our results suggest that a 4% concentration of lidocaine HCl with 1:100,000 epinephrine has better clinical efficacy than 2% lidocaine HCl with 1:100,000 epinephrine when used for surgical extraction of lower third molars. Neither drug had any clinical adverse effects.
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Humans , Arterial Pressure , Epinephrine , Follow-Up Studies , Heart Rate , Hemodynamics , Lidocaine , Molar, Third , Mouth , Single-Blind Method , Treatment OutcomeABSTRACT
Objective To observe the expression of calcium/calmodulin dependent protein kinase Ⅱ (CaMK Ⅱ) in the spinal cord of the rats followed lidocaine hydrochloride intrathecal injection.Methods 48 male SD rats weight(230 ± 20) g,after intrathecal indwelling catheter,were randomly divided into four groups (n =12,8 rats for behavioral detection and 4 rats for western blotting):normal group (C group),sham group (S group),DMSO group (D group),10％ lidocaine group (L group).Mechanical withdrawal threshold(MWT) and thermal withdrawal latency(TWL) were detected before and after 2 h,4 h,8 h,12 h,1 d,2 d,3 d,4 d and 5 d with drug treatment.Intumescentia lumbalis of the spinal cord were collected to measure the expression of CaMK Ⅱ with western blotting after drug treatment for 12 h.Results The based MWT of the rats in C,S and D group were (11.2 ± 3.1) g,(11.8 ± 2.2) g and (11.4 ± 2.4) g respectively.There were no differences among the every time points (n=8,P＞0.05).The MWT of the rats in L group significantly increased at 2 h,4 h,8 h,12 h,1 d,2 d,3 d and 4 d after treatment with lidocaine hydrochloride,and the data were (22.0 ± 6.6) g,(22.2 ± 5.3) g,(20.5 ±5.8)g,(18.5 ±4.3)g,(16.7 ±3.2)g,(15.2 ±3.1)g,(15.5 ±3.5)g,(13.7 ±2.4)g respectively (n=8,P＜0.01).TWL had no difference among the rats in C,S,and D group(n=8,P＞0.05).The TWL of the rats in L group significantly increased at 2 h,4 h,8 h,12 h,1 d,2 d and 3 d after treatment with lidocaine hydrochloride(n =8,P＜ 0.01).The expression of CaMK Ⅱ of the rats in C group,S group,D group and L group were 0.17 ± 0.03,0.16 ± 0.03,0.19 ± 0.05,0.42 ± 0.11,and significantly upregulated in L goup (n =4,P ＜ 0.01).Conclusion Lidocaine hydrochloride intrathecal injection can increase the expression of the CaMK Ⅱ in the spinal cord of the rats.Those indicate that CaMK Ⅱ may be involved with the nerve damage induced by lidocaine hydrochloride.
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OBJECTIVE:A sensitive spectrophotometric method is developed for determination of content of lidocaine hydrochloride in different medium. METHODS:Lidocaine hydrochloride reacts with bromocresol purple to form an ion-association complex, the colors of solutions change obviously, the absorption wavelength at 588 nm and at 426nm were determined by spectrophotometric method for the content of lidocaine hydrochloride.. RESULTS:At wavelength 588 and 426nm, the concentration of lidocaine hydrochloride in the range of 2.76?10-6～2.83?10-5 and 5.64?10-6～2.48?10-5 mol?L-1 respectively follows obeys Beer's law, the apparent molar absorptivity are 1.45?104 and 7.11?103 L?mol-1?cm-1, the detection limit are 8.37?10-7 and 1.71?10-6 mol?L-1 . CONCLUSION:The method has high sensitivity and fairly good selectivity, applied to the determination of lidocaine hydrochloride in medicine samples and human serum and human urine.
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@# Objective To explore the effect of preoperative local blocking with compound lidocaine hydrochloride (CLH) on postoperative pain of patients undergoing craniotomy.Methods40 patients suffered from superatentorial occupying lesion and scheduled for craniotomy were randomly divided into the CLH group and control group with 20 cases in each group. In the CLH group, local blocking with CLH was performed just before craniotomy, while in control group local blocking with 0.5% procaine was performed preoperatively and all patients of two groups used patient-controlled intravenous analgesia (PCIA) with fentanyl postoperatively. Postoperative pain was assessed for 48 hours according to visual analogue scale (VAS), and the comparison of analgesia-related postoperative complications of the two groups was demonstrated.ResultsThere was no significant difference in VAS postoperatively and incidence rate of complications between two groups ( P>0.05).ConclusionCompound lidocaine hydrochloride local infiltration may provide a safe and effective analgesia for postoperative pain in patients after craniotomy.
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OBJECTIVE:To establish a bacterial endotoxin test for compound diclofenac sodium and lidocaine hydrochlo?ride injection(CDL).METHODS:The limitation of endotoxin in CDL was determined and a interference test was performed to determine the maximum non-interference concentration.RESULTS:CDL could interfere the detection of bacterial endotoxin,which could be overcome through300-fold dilution of the preparation.CONCLUSION:The bacterial endotixin test can be used to replace the detection of pyrogen in CDL.