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Statistical analysis | The sample size was calculated using MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium) to find the null hypothesis with the area under the receiver operating characteristic (AUROC) curve of 0.5 and AUROC of 0.80. We calculated a minimum of 45 patients for a study power of 80% and an error of 0.05 because it is assumed that the success rate of the infraclavicular block is more than 80%.The data collected in the study were analyzed using the SPSS 22.0 (Statistical Package for the Social Sciences) program. The normality of the distributions of the variables was tested using visual (histograms and probability plots) and analytical (Shapiro–Wilk test) methods. Levene’s test was used to check the homogeneity of the group variances. The mean differences between two groups were analyzed with Student’s t test. In the intragroup comparisons of time-related changes, the Friedman test was used for the non-normally distributed variables. For the post hoc comparisons, Wilcoxon signed-rank test was applied separately for pair of groups. Each output was reported by applying Bonferroni correction. The receiver operating characteristic (ROC) curve was used to examine the recorded values for our outcome criteria in terms of their diagnostic value. The Hanley and McNeil method was used to calculate the ROC curve and the area under the ROC curve (AUC). AUC values close to 1.0 were interpreted as indicating an improvement in prediction accuracy. The type 1 error rate of 5% was accepted for significance in all statistical analyses. | PMC10171442 |
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Discussion | paresthesia, BP block, peripheral block | VASODILATATION, VASODILATION, PARESTHESIA, BLIND | Over the years, several techniques have been used to achieve successful and safe peripheral block application. The paresthesia technique is a blind technique based on direct contact with nerve fibers. This technique is based on the perception of stimulation sensation and is a subjective technique that can be confusing in most cases. The NS technique, on the other hand, is based on finding the inverse relationship between current intensity and distance to show the proximity of the needle to the nerve. The NS technique has been shown to be a highly effective technique for determining the correct needle position for induction of local anesthesia [In our study, after evaluating the vital signs of the patients by monitoring their values, sedoanalgesia was induced with 1 mg midazolam and 50 µg fentanyl before the block procedure. Studies have shown that BP blocks can be performed in awake or mildly sedated patients by an experienced anesthesiologist [Successful BP block is associated with reduced vascular tone and increased blood flow. PI represents the ratio of the pulsatile and non-pulsatile components of peripheral blood flow to each other. During vasodilation, the increase in the pulsatile flow leads to an increase in the PI value. Available data demonstrate that PI is a sensitive parameter to express the vasomotor tone loss induced by LAs. Therefore, PI can be considered an objective measure of peripheral perfusion, which can predict the success of peripheral block [In cases of vasodilatation, a relative increase in the pulsatile blood flow leads to an increase in the PI value. Thus, PI is considered an objective measure for predicting the peripheral block success. The efficacy of PI in predicting the peripheral block success has been demonstrated in BP blocks [Our study aimed to present the diagnostic relationships between sensory block and motor block development and PI values and to determine the optimal cutoff points for PI values. Using the pinprick test, sensory block was detected at 7.98 ± 1.49 min. The mean PI value at which the test became positive was 8.5 ± 2.46. In the ROC analyses, it was seen that an increase of 3.8 units or more in the PI value calculated starting at 5 min after block induction could predict the development of sensory block with 82% sensitivity and 82% specificity. Using MBS grade 3 tests, motor block was detected at 11.08 ± 1.71 min. The mean PI value at which the test became positive was 8.86 ± 2.6. It was found that an increase of 3.9 units or more in the PI value calculated starting at 3 min after block induction could predict the development of motor block on the level of MBS grade 3 with 84% sensitivity and 84% specificity.The literature review revealed that, while there were numerous studies in which PI values demonstrated BP block success, few studies had separately analyzed sensory and motor blocks using PI values. In this sense, our study is the first example of this in the literature. As stated above, the PI cutoff values reported in different studies in the literature differ from each other. It is believed that these differences were caused by differences in the methodologies of the studies, such as the type and volume of LA used, the type of blockades applied, and the experience of the practitioners.Some limitations of our study should be mentioned. Patient-related differences in the assessment of block success may have resulted from the subjective methods we used to evaluate the establishment of the sensory and motor blocks. The fact that the study was single-centered and all infraclavicular blocks were performed by a single anesthesiologist can also be considered as limitation. Finally, PI values vary with age. It is predicted that different age groups have different cutoff values [ | PMC10171442 |
Conclusion | PI is a useful and objective metric in the prediction of the infraclavicular PB block success. It was found that block success may be predicted by degrees of increase of 3.8 or higher for sensory block and 3.9 or higher for motor block.Conflicts of interest: Authors declare no conflicts of interest.Funding: Authors received no specific funding for this work. | PMC10171442 |
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References | PMC10171442 |
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Background | hip arthroplasty, postoperative pain, THA | This investigation aimed to evaluate the impact of continuous pericapsular nerve group (PENG) block and continuous fascia iliac compartment block (FICB) on postoperative pain following total hip arthroplasty (THA). | PMC10334586 |
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Methods | femoral neck fractures, fifty-seven, nausea and vomiting, infection, hematoma, catheter detachment | ADVERSE EVENTS, INFECTION, HEMATOMA | This prospective, randomized, and controlled trial recruited a cohort of fifty-seven patients with unilateral femoral neck fractures from Xi’an Aerospace General Hospital in northwest China between July 2020 and November 2021. These patients were randomly assigned to two groups: the continuous PENG block group (PENG group, n = 29) and the continuous FICB group (FICB group, n = 28). Under ultrasound guidance, PENG block and FICB procedures were performed prior to spinal anesthesia, utilizing 20 ml of 0.25% ropivacaine for PENG block and 30 ml of 0.25% ropivacaine for FICB. Subsequently, a catheter was inserted. All study participants received a standardized postoperative multimodal analgesic regimen, including intravenous administration of 30 mg Ketorolac tromethamine every eight hours and patient-controlled neural analgesia (PCNA) after surgery. Numerical rating scale (NRS) scores at rest and during exercise were recorded at various time points: prior to block (T0), 30 min post-blockade (T1), and 6 h (T2), 12 h (T3), 24 h (T4), and 48 h (T5) postoperatively. Additional data collected encompassed postoperative quadriceps muscle strength, the time of initial ambulation after surgery, the number of effective PCNA activations, rescue analgesia requirements, and occurrences of adverse events (such as nausea and vomiting, hematoma, infection, catheter detachment, or displacement) within 48 h following surgery. | PMC10334586 |
Results | pain | In the PENG group, the resting NRS pain scores exhibited lower values at T1, T4, and T5 than those at T0. Furthermore, exercise NRS pain scores at T1-T5 were lower in the PENG group than in the FICB group. Similarly, during the same postoperative period, the PENG group demonstrated enhanced quadriceps strength on the affected side compared to the FICB group. Additionally, the PENG group displayed earlier postoperative ambulation and reduced occurrences of effective PCNA activations and rescue analgesia requirements compared to the FICB group. | PMC10334586 |
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Conclusion | THA | Continuous PENG block exhibited superior analgesic efficacy after THA compared to continuous FICB, promoting recovery of quadriceps strength on the affected side and facilitating early postoperative ambulation. | PMC10334586 |
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Trial Registration | This clinical trial was registered in the China Clinical Trials Center ( | PMC10334586 |
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Keywords | PMC10334586 |
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Introduction | postoperative pain, postoperative quadriceps muscle strength, infection, Total hip arthroplasty, hematoma, catheter detachment, THA, nausea, vomiting | ADVERSE EVENTS, INFECTION, THROMBOEMBOLIC EVENT, HEMATOMA | The hip joint, a crucial ball-and-socket joint essential for lower limb mobility [Total hip arthroplasty (THA) is a commonly employed procedure for FNF treatment. However, severe postoperative pain following THA delays motor function recovery, increases the risk of hospitalization and thromboembolic events, and adversely affects long-term patient outcomes [This study aims to compare the analgesic efficacy and safety of continuous PENG block with continuous FICB during the perioperative period in elderly patients with FNF. The primary outcomes to be evaluated include the numerical rating scale (NRS) scores at rest and during exercise, recorded prior to block (T0), 30 min post-blockade (T1), and at 6 h (T2), 12 h (T3), 24 h (T4), and 48 h (T5) postoperatively. Secondary outcomes encompass postoperative quadriceps muscle strength, the time of initial ambulation after surgery, the number of effective patient-controlled neural analgesia (PCNA) activations, rescue analgesia requirements, and occurrences of adverse events (such as nausea, vomiting, hematoma, infection, catheter detachment, or displacement) within 48 h following surgery. | PMC10334586 |
Materials and methods | PMC10334586 |
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Study design | This prospective, randomized, and controlled trial received approval from the Hospital Medical Ethics Committee (Lot No. XHTZYY-2020-LL-02) on 08/07/2020 and was registered with the China Clinical Trials Center (
Flowchart of the entry group | PMC10334586 |
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Grouping and interventions | anterior inferior iliac spine | Treatment allocation was concealed using consecutively numbered, sealed, opaque envelopes held by an anesthesia nurse who was not involved in the study. The envelopes were handed to the anesthesiologist performing the nerve block on the day of surgery. Both groups of patients fasted for eight hours and refrained from clear liquids for 2 h before surgery. In the preoperative holding area, all study patients received intravenous parecoxib sodium 40 mg and fentanyl 1.5 µg/kg. Upon entering the operating room, non-invasive arterial blood pressure (NIBP), heart rate (HR), pulse oximetry (SpO2), and three-lead electrocardiogram (ECG) were continuously monitored.The procedure in the PENG group [
Continuous PENG block. AIIS: anterior inferior iliac spine; white asterisk: catheter trajectory; IPE: iliopubic eminence; LA: local anesthetic; PT: psoas major tendon; IM: iliacus muscle; white triangle: iliac Fascia; FA: femoral arteryThe procedural technique employed in the FICB group followed a previously conducted study [
Continuous FICB. SM: sartorius muscle; white asterisk: catheter trajectory; LA: local anesthetic; IM: iliacus muscle; IB: iliac bone; white triangle: iliac Fascia; IOM: internal oblique muscle | PMC10334586 |
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Anesthesia application | skin pain | BLOOD, LOCAL INFILTRATION | Thirty minutes after completion of the block, the patient was repositioned in the healthy side-lying position, with the affected side facing upward, and spinal anesthesia was performed at the L3-4 interspace. Upon penetration of the spinal anesthesia puncture needle into the arachnoid and subsequent cerebrospinal fluid outflow, 2.5-3.0 ml of 0.25% bupivacaine was slowly administered to maintain the sensory block level at T10. Blood pressure (BP) and heart rate (HR) were maintained within 20% of the basal value during the operation.In both groups, local infiltration anesthesia with 10 ml of 0.25% ropivacaine was performed at the incision site before the conclusion of the surgery. Neither the PENG block nor the FICB provided a complete blockade of the surgical incision area. Therefore, a local infiltration block was performed in both groups before suturing the skin to ensure uniform analgesia in the incision area and eliminate confounding factors associated with superficial skin pain.The same orthopedic team performed the surgical procedures, who had completed approximately 40 PENG/FICB block cases before enrolling patients. Perioperative observation parameters were assessed and recorded by the same anesthesiologist who was not involved in the study. | PMC10334586 |
Postoperative analgesia protocol and rescue analgesic | NRS | Following the surgical procedure, patients were admitted to the post-anesthesia care unit (PACU) and subsequently transferred to the ward upon stabilization of vital signs. All patients received the same postoperative multimodal analgesia regimen, which included intravenous administration of ketorolac tromethamine 30 mg every eight hours and patient-controlled neural analgesia (PCNA) after surgery. The PCNA formula consisted of 0.10% ropivacaine (300 ml), and the parameters for PCNA was set as follows: continuous infusion dose of 5 ml/h, bolus dose of 5 ml, lock time of 30 min, and continuous analgesia for 48 h. In cases where the NRS was ≥ 4 points and persisted for more than 30 min, intravenous rescue analgesia was administered using oxycodone hydrochloride at a dose of 0.1 mg/kg. | PMC10334586 |
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Measurements | NRS, pain | The numerical rating scale (NRS) at rest and during exercise were recorded as the primary outcome at multiple time points: before block (T0), 30 min post-blockade (T1), and 6 h (T2), 12 h (T3), 24 h (T4), and 48 h (T5) postoperatively. Exercise pain was evaluated based on the NRS score corresponding to passive straight leg elevation at 15° [The NRS scores were employed to evaluate the level of pain experienced by the patients, with 0 points indicating no pain, 1–3 points indicating mild pain, 4–7 points indicating moderate pain, and 8–10 points indicating severe pain. Quadriceps strength was assessed using an OE-210 hand-held dynamometer (HDD) (Ito Ultra Shortwave, Japan) at 24 and 48 h postoperatively [ | PMC10334586 |
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Statistical analysis | NRS | The Kolmogorov-Smirnov normality test was conducted for continuous variables. Normally distributed variables were expressed as mean ± standard deviation (SD), and independent samples t-test was used for between-group comparisons. Non-normally distributed variables were expressed as median (interquartile range, IQR) [M (Q1, Q3)], and the Mann-Whitney U test was employed for between-group comparisons. Repeated-measures ANOVA was utilized to compare multiple time points. Count data were presented as the number of cases, and the Chi-square test or Fisher’s exact probability analysis was conducted for between-group comparisons. The significance level was set at α = 0.05, and differences were considered statistically significant at P < 0.05.The sample size calculation was based on a pilot study that included eight patients in each group using PASS 11 software. The calculation was performed based on the 24-hour postoperative exercise NRS scores in both groups (3 [ | PMC10334586 |
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Results | PMC10334586 |
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General information | intraoperative bleeding, SD | INTRAOPERATIVE BLEEDING | A total of 60 patients were initially recruited for the study, with one patient excluded from the PENG group due to the operation duration exceeding 3 h. Ultimately, the statistical analysis included 29 cases in the PENG group. Similarly, one patient was excluded from the FICB group due to lumbar puncture difficulty, and an additional patient withdrew voluntarily, resulting in 28 cases included in the statistical analysis for the FICB group. There were no significant differences in age, gender, BMI, ASA classification, surgical time, and intraoperative bleeding between the two groups (all P > 0.05). The detailed data are shown in Table
Comparison of the general conditions of patients in the two groupsData are presented as mean ± SD or number of patients. | PMC10334586 |
Comparison of postoperative motor ability and postoperative analgesia | SD | When comparing quadriceps strength on the affected side during the same postoperative period, the PENG group exhibited higher strength than the FICB group. Furthermore, the quadriceps strength on the affected side in the FICB group was lower than that of the healthy side in the same group at 24 and 48 h postoperatively, with statistically significant differences (P < 0.05). Additionally, the PENG group had an earlier time of initial ambulation after surgery than the FICB group. The detailed data are shown in Table
Comparison of motor ability between the two groups after surgeryData are presented as mean ± SD. When comparing the number of effective PCNA presses during the same postoperative period, the PENG group had a lower number than the FICB group. Moreover, the number of rescue analgesia administrations from 0 to 24 h after surgery was lower in the PENG group compared to the FICB group, with a statistically significant difference (P < 0.05). The detailed data are shown in Table
Comparison of postoperative analgesia between the two groups after surgeryData are presented as mean ± SD or number (times). | PMC10334586 |
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Comparison of adverse reactions | Hematoma, nausea, infection, vomiting | HEMATOMA, INFECTION | No nausea and vomiting occurred in the PENG group, but 3 cases occurred in the FICB group, and the difference was not statistically significant (P > 0.05). Hematoma, or infection at the puncture site, was observed between the two groups. Additionally, there were no instances of catheter displacement after surgery. | PMC10334586 |
Discussion | femoral neck fractures, femoral nerve block, nausea and vomiting, postoperative exercise pain, pain, PENG block, THA | ADVERSE REACTIONS | In this study, a total of 57 patients with femoral neck fractures were randomly assigned to receive either continuous pericapsular nerve group (PENG) block (PENG group, n = 29) or continuous fascia iliaca compartment block (FICB group, n = 28). The results showed that both groups improved exercise NRS pain scores during the observation period compared to preoperative scores. However, the passive straight leg raises 15° VAS scores were consistently lower in the PENG group than in the FICB group during the same time frame. The possible reasons for this discrepancy can be analyzed as follows. Swenson et al. discovered through magnetic resonance imaging that using 30 ml of 0.25% bupivacaine for FICB did not reach the pectineus muscle effectively, failing to achieve complete obturator nerve blockade [A previous investigation has demonstrated the beneficial impact of early mobilization on postoperative recovery and length of hospital stay [The findings of this investigation indicate that, in the PENG group, postoperative quadriceps strength on the affected side was slightly lower than that of the healthy side (without statistical significance). In contrast, the FICB group exhibited significantly lower quadriceps strength on the affected side than the healthy one. Furthermore, during the same period, the postoperative quadriceps strength on the affected side was significantly higher in the PENG group than in the FICB group. These outcomes are consistent with a previous study by Hao et al., which demonstrated improved quadriceps strength with PENG block in patients undergoing THA [The findings of this investigation revealed that the PENG group exhibited a significantly lower number of effective PCNA compressions in the postoperative 0–24 h and 24–48 h periods, as well as a lower number of rescue analgesia administrations compared to the FICB group (P < 0.05). This observation may be attributed to the challenges faced by the FICB group in achieving a complete obturator block nerve or even femoral nerve block, given the constant 5 ml/h continuous infusion dose of PCNA for the iliac fascia gap area and the diminishing effect of spinal anesthesia. Consequently, more PCNA compressions and rescue analgesia were required in the FICB group to alleviate postoperative exercise pain. These findings suggest that a higher continuous infusion dose of PCNA may be necessary to effectively manage exercise pain 24 h after THA in continuous FICB. Notably, three individuals in the FICB group experienced nausea and vomiting after receiving ketorolac tromethamine for rescue analgesia. However, no significant difference between the two groups was observed in the occurrence of nausea and vomiting. Further investigations with an expanded sample size are warranted to validate these findings. Importantly, no adverse reactions such as puncture site hematoma or catheter displacement were observed in either group after surgery, which aligns with previous research [ | PMC10334586 |
Acknowledgements | Not applicable. | PMC10334586 |
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Author contributions | Lei Duan, Conceptualization, Formal analysis, Investigation, Methodology, Validation, Visualization, Writing-original draft, Writing-review & editing. Liang Zhang, Conceptualization, Formal analysis, Investigation, Methodology, Validation, Visualization, Writing - original draft, Writing - review & editing. Chuang-Guo Shi, Formal analysis, Investigation, Methodology, Validation. Li-Gang Huang, Formal analysis, Investigation, Methodology. Hui Ao, Investigation, Methodology. Ze-Peng Wang, Formal analysis, Investigation. Yue Deng, Methodology, Supervision. Meng-Liang Sun, Conceptualization, Formal analysis, Funding acquisition, Methodology, Project administration, Resources, Supervision, Validation, Visualization, Writing - review & editing. Lei Duan and Liang Zhang contributed equally to this study. | PMC10334586 |
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Funding | This study was funded by the 2021 Xi’an Health Research Talent Project (No. 2021yb57) and the 2020 Medical Research Project of Xi’an Aerospace General Hospital (No. 2020KY001). | PMC10334586 |
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Data availability | The datasets used in the current study are available from the corresponding author upon reasonable request. | PMC10334586 |
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Declarations | PMC10334586 |
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Competing interests | The authors declare no competing interests. | PMC10334586 |
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Ethics approval and consent to participate | This work followed the Consolidated Standards of Reporting Trials (CONSORT) statement and the Declaration of Helsinki. This clinical trial was registered in the China Clinical Trials Center ( | PMC10334586 |
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Consent for publication | Not applicable. | PMC10334586 |
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Abbreviations | inferior iliac spineIliopubic | Pericapsular nerve groupFascia iliac compartment blockTotal hip arthroplastyNumerical rating scalePatient-controlled neural analgesiaFemoral neck fracturesNon-invasive arterial blood pressureHeart ratePulse oximetryElectrocardiogramConsolidated Standards of Reporting Trials90% minimum effective volumeAnterior inferior iliac spineIliopubic eminencePsoas tendonFascia iliacHand-held dynamometer | PMC10334586 |
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References | PMC10334586 |
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Background | Gastrointestinal (GI) symptoms, RRMS | RELAPSING-REMITTING MULTIPLE SCLEROSIS | Gastrointestinal (GI) symptoms affect more than 80% of individuals with relapsing-remitting multiple sclerosis (RRMS). Ginger is widely known for its GI relieving properties. Therefore, we investigated the effect of ginger supplementation on common GI symptoms in RRMS patients. | PMC10605938 |
Methods | bloating, nausea, flatulence, diarrhea, abdominal pain, heartburn, constipation, dysphagia, anorexia | ANOREXIA | This study was a 12-week double-blind parallel randomized controlled trial with a 3-week run-in period. The intervention (n = 26) and control (n = 26) groups received 500 mg ginger and placebo (as corn) supplements 3 times a day along with main meals, respectively. At the beginning and end of the trial, the frequency and severity of constipation, dysphagia, abdominal pain, diarrhea, bloating, belching, flatulence, heartburn, anorexia, and nausea were assessed using the visual analogue scale ranging from 0 to 100 mm. Totally, 49 participants completed the study. However, data analysis was performed on all 52 participants based on the intention-to-treat principle. | PMC10605938 |
Results | In comparison with placebo, ginger supplementation resulted in significant or near-significant reductions in the frequency (-23.63 ± 5.36 vs. 14.81 ± 2.78, | PMC10605938 |
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Conclusion | bloating, abdominal pain, constipation, nausea,, RRMS | Ginger consumption can improve constipation, nausea, bloating, and abdominal pain in patients with RRMS. | PMC10605938 |
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Trial Registration | This trial was prospectively registered at the Iranian Registry of Clinical Trials ( | PMC10605938 |
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Keywords | PMC10605938 |
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Background | MULTIPLE SCLEROSIS (MS) | Multiple sclerosis (MS) is a chronic neurodegenerative disease of autoimmune origin [Ginger (Considering the high prevalence of GI problems in MS patients and the positive effects of ginger on the digestive system [ | PMC10605938 |
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Materials and methods | PMC10605938 |
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Trial design | This study was a 12-week double-blind parallel randomized placebo-controlled trial with a 3-week run-in period. It was conducted in agreement with the Declaration of Helsinki and its later amendments. Eligible patients were recruited from Fars MS Association and Imam Reza (A.S) Clinic located in Shiraz, Iran. Before the enrollment, informed consent was obtained from the participants. This trial was approved by the Medical Ethics Committee at the Isfahan University of Medical Sciences under the ethics code IR.MUI.RESEARCH.REC.1400.248. Also, it was prospectively registered at the Iranian Registry of Clinical Trials ( | PMC10605938 |
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Participants | Based on the sample size calculation described in detail in our published study protocol [ | PMC10605938 |
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Randomization and blinding | RRMS | Eligible RRMS patients were assigned to ginger and placebo groups using stratified permuted block randomization (allocation ratio = 1:1, block size = 4). The stratification was performed according to gender. The following website was used for the generation of random allocation sequence: | PMC10605938 |
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Run-in period | RRMS | Before random allocation, eligible participants underwent a three-week run-in period. During this time, RRMS patients were requested to avoid consuming ginger and its products and to maintain their usual physical activity and dietary intake. | PMC10605938 |
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Intervention | The treatment and control groups received 500 mg ginger and placebo (corn) tablets thrice a day with main meals for 12 weeks, respectively. Each 500 mg ginger tablet was standardized to contain 25 mg gingerols. Ginger and placebo supplements were provided by Dineh Iran Industries Complex, Tehran, Iran. During the trial, both groups were asked to maintain their usual diet and physical activity and to avoid consuming ginger and other products containing it. In addition, possible side effects of the intervention were evaluated according to the trial protocol [ | PMC10605938 |
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GI symptoms | bloating, nausea, flatulence, diarrhea, abdominal pain, heartburn, constipation, dysphagia, anorexia | ANOREXIA | At the beginning and end of this trial, the frequency and severity of constipation, dysphagia, abdominal pain, diarrhea, bloating, belching, flatulence, heartburn, anorexia, and nausea were assessed using the visual analogue scale (VAS) ranging from 0 mm (none) to 100 mm (worst possible). This assessment tool has previously been applied and validated by Preziosi et al. to evaluate GI symptoms in patients with MS [ | PMC10605938 |
Physical activity and dietary intake | Physical activity and dietary intake can affect GI symptoms [ | PMC10605938 |
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Statistical analysis | Data analysis was performed according to the intention-to-treat (ITT) principle using IBM SPSS Statistics software (version 26, IBM Corporation, Armonk, New York, United States). The expectation-maximization algorithm was run to impute missing values in ITT analysis [ | PMC10605938 |
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Discussion | dysphagia, bloating, flatulence, diarrhea, abdominal pain, heartburn, dyspepsia, anorexia, constipation, nausea and constipation, nausea,, RRMS, Constipation | DYSPHAGIA, ANOREXIA | The findings of this study indicated that 1500 mg/d ginger supplementation for 12 weeks statistically significantly reduced the frequency and severity of nausea and constipation as well as the severity of bloating. In addition, supplementation with ginger caused statistically near-significant reductions in the frequency of bloating and the severity of abdominal pain in patients with RRMS. Nevertheless, ginger consumption showed no significant impact on the frequency and severity of dysphagia, diarrhea, belching, flatulence, heartburn, and anorexia and the frequency of abdominal pain. It is noteworthy that the side effects of ginger in this study were rare and mild, representing a very good safety profile.Interestingly, the highest reduction in GI symptoms after ginger supplementation belonged to constipation in this trial. Constipation is the most common GI problem in RRMS patients and is caused by prolonged colonic transit time and altered colonic compliance and basal tone [Consistent with our findings, previous studies have reported that ginger supplementation can improve constipation without causing diarrhea [The results of previous studies are controversial regarding the effect of supplementation with ginger on dyspepsia symptoms. Consistent with our findings, several trials reported positive effects of ginger on at least one dyspepsia symptom, such as nausea, bloating, and abdominal pain [In line with our results, a systematic review of 109 clinical trials has indicated that ginger has a very good safety profile [In the authors’ opinion, the management of prevalent GI problems such as constipation and dyspepsia in MS patients can improve their quality of life, well-being, daily functioning, and work ability. The prokinetic effects of ginger can alleviate constipation, and the stimulatory effects of ginger on digestive enzymes can relieve dyspepsia in long-term use [Finally, this trial has some strengths and limitations that should be acknowledged. The first strength is the novelty of the work. To the best of our knowledge, this study is the first one that investigated the effect of ginger supplementation on GI symptoms in patients with MS. The second strength is the assessment of key potential confounders including dietary intake and physical activity during the intervention. On the other hand, the first limitation is that this trial was conducted on RRMS patients; therefore, its findings may not be generalizable to other types of MS. The second limitation is that the frequency and severity of GI symptoms were mild to moderate in this study; therefore, it is unclear whether our results are applicable to more severe cases. These limitations need to be considered in the design of future clinical trials. | PMC10605938 |
Conclusion | bloating, abdominal pain, constipation, nausea,, RRMS | In conclusion, ginger consumption seems to alleviate GI symptoms in patients suffering from RRMS. Particularly, ginger supplementation can improve constipation, nausea, bloating, and abdominal pain in patients with RRMS. Nevertheless, further clinical trials and mechanistic studies are necessary to confirm these findings. | PMC10605938 |
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Acknowledgements | Not applicable. | PMC10605938 |
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Authors’ contributions | RA, MP | SF and RA conceptualized and designed the study. SF and MP administered supplements and collected data. SF and ZH analyzed data. SF wrote the manuscript, and RA critically revised it. All authors read and approved the final manuscript. | PMC10605938 |
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Funding | This article was extracted from the PhD thesis of Sahar Foshati and was funded by Isfahan University of Medical Sciences under grant number 3400357. The funding source had no role in the conception and design of the trial, data collection, statistical analysis, interpretation of results, and manuscript preparation. | PMC10605938 |
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Data Availability | The data supporting the results of this trial are available from the corresponding author, upon reasonable request. | PMC10605938 |
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Declarations | PMC10605938 |
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Ethics approval and consent to participate | This trial was done in agreement with the Declaration of Helsinki and its later amendments. It was approved by the Ethics Committee at the Isfahan University of Medical Sciences under the code IR.MUI.RESEARCH.REC.1400.248. Before the enrollment, informed consent was obtained from the participants. | PMC10605938 |
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Consent for publication | Not applicable. | PMC10605938 |
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Competing interests | The authors declare no competing interests. | PMC10605938 |
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References | PMC10605938 |
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Key Contribution | Aflatoxin BNaturally occurring concentrations of AFB | PMC9964898 |
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1. Introduction | Aflatoxins (AF), produced by The US Food and Drug Administration has established 20 μg/kg as the action level for AFBThe detrimental effects of AFBTo the best of our knowledge, only one recent study examined the effects of a close to naturally occurring concentration of AFB | PMC9964898 |
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2. Results | The basal diet provided 15.9% of crude protein (CP) and 1.61 Mcal/kg of DM (Ruminal pH, NHThe dose of AFBFlows of total N, NHAflatoxin B | PMC9964898 |
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3. Discussion | Previous studies have investigated the effects of AFBPrevious in vitro studies have reported lower concentrations of VFA and NHThe lack of treatment effects on fermentation probably reflects the lack of AFBAflatoxin BPrevious studies examined the recovery of AFBIn a study where AFB | PMC9964898 |
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4. Conclusions | Aflatoxin B | PMC9964898 |
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5. Materials and Methods | The dairy cows used in this study for ruminal content collection were cared for in accordance with guidelines approved by the University of Florida Institutional Animal Care and Use Committee protocol number 202009849. | PMC9964898 |
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5.1. Experimental Design, Treatments, and Diet | A. H. Thomas | Eight dual-flow continuous culture fermenters were used in a replicated 4 × 4 Latin square design. Each fermenter vessel was treated as an experimental unit. Four fermentation periods of 10 d each, consisting of 7 d of adaptation and 3 d of sampling were carried out. Fermenters were randomly assigned to 1 of 4 AFBThe basal diet was formulated to meet the nutrient requirements of a lactating Holstein dairy cow (680 kg of body weight) producing 42 kg of milk/d, 3.5% milk fat, 3% milk protein, and 4.8% lactose based on the NRC (2001) model. Corn silage was dried in a forced-air oven at 60 °C until the DM was 90% to allow for proper grinding of the feed. Dried corn silage, corn grain, soybean meal, and the mineral premix were ground through a 2 mm screen in a Wiley mill (A. H. Thomas Co., Philadelphia, PA, USA). Alfalfa hay and citrus pulp pellets were included as purchased in the diets. Each fermenter was fed 107 g of DM per day. The diet was fed in two equal allowances at 0800 (8 AM) and 1800 h (6 PM) daily. We chose two timings to mimic twice a day feeding of dairy cows. | PMC9964898 |
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5.2. Dual-Flow Continuous Culture System Operation and Experimental Period | A dual-flow continuous culture system [Two ruminally cannulated lactating Holstein cows were used as ruminal content donors. Donor cows were fed a total mixed ration containing (DM basis) corn silage (40%), alfalfa hay (3%), ground corn (27.3%), soybean meal 44% (15.5%), citrus pulp (9.2%), and mineral and vitamin premix (5%). Approximately 2 h after morning feeding, ruminal contents were manually collected and filtered through four-layer cheesecloth into prewarmed thermos flasks, which were kept airtight until transported to the laboratory for pooling across cows (50:50 mix; vol/vol). Pooled ruminal content was added to each prewarmed (39 °C) fermenter vessel until it reached the solid effluent outflow.On d 5 of each period, artificial saliva was exchanged for | PMC9964898 |
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5.3. Fermentation Profile | Ruminal pH was measured in each fermenter vessel using a portable pH meter (Thermo Scientific Orion Star A121, Thermo Fisher Scientific Inc., Waltham, MA, USA) at 0, 1, 2, 4, 6, and 8 h post-morning feeding during d 8 and 9 of each period. Aliquots of approximately 15 mL of ruminal content from each fermenter were filtered through four layers of cheesecloth to obtain a 10-mL sample that was immediately acidified with 0.1 mL of 50% H | PMC9964898 |
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5.4. Nutrient Digestibility | A. H. Thomas | ASH | Diet samples were ground through a 1 mm screen in a Wiley mill (A. H. Thomas Co.) and dried in an oven overnight at 105 °C for DM estimation. Samples were ashed at 550 °C for 5 h [For the estimation of ruminal nutrient digestibility, digesta samples collected on d 8, 9, and 10 were freeze-dried for DM determination and immediately ground using a mortar and pestle and analyzed for OM, N, aNDF, ADF, and starch as earlier described. To estimate ruminal true digestibility of nutrients, artificial saliva collected on d 5 was freeze-dried for DM estimation and analyzed for total N and ash as previously described. We used the following equation for nutrient digestibility estimation [ | PMC9964898 |
5.5. Microbial Protein Synthesis and Ruminal N Metabolism | At the end of each experimental period, microbial pellets from each fermenter vessel were harvested [We used The percent excess of Flows of NHMicrobial efficiency was determined as follows [Efficiency of N used was determined as follows [ | PMC9964898 |
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5.6. Aflatoxin B | Ruminal contents (5 mL) from each fermenter were collected at 0, 1, 2, 4, 6, and 8 h after the morning feeding on d 8 and 9. Samples were transferred to screw-capped tubes and frozen at −20 °C until analyzed. We used an ELISA-based kit (AgraQuant | PMC9964898 |
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5.7. Statistical Analysis | Data were analyzed using the GLIMMIX procedure of SAS (version 9.4; SAS Institute, Cary, NC, USA) as a replicated 4 × 4 Latin square design. Data were checked for normality using the UNIVARIATE procedure of SAS (version 9.4; SAS Institute) before analysis. Variables that were measured repeatedly over time (pH, lactate, VFA, NHIn addition, linear, quadratic, and cubic contrasts were tested to examine trends in effects of the dose. Significance was declared at | PMC9964898 |
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Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC9964898 |
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Author Contributions | Conceptualization, F.X.A., Y.J., A.T.A. and D.V.; methodology, F.X.A., Y.J., A.P.F. and D.V.; formal analysis, F.X.A. and D.V.; investigation, F.X.A., K.A., M.R.P., B.C.A., S.L.B., J.R.V., L.T., R.R.L. and A.P.-C.; resources, D.V. and A.P.F.; data curation, F.X.A., J.A.A.-C. and D.V.; writing—original draft preparation, F.X.A.; writing—review and editing, D.V., A.P.F., J.A.A.-C., B.C.A., J.R.V. and A.T.A.; visualization, F.X.A. and D.V.; supervision, F.X.A., K.A. and D.V.; project administration, D.V. and K.A. All authors have read and agreed to the published version of the manuscript. | PMC9964898 |
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Institutional Review Board Statement | The animal study protocol was approved by the Institutional Animal Care and Use Committee of UNIVERSITY OF FLORIDA (protocol code 202009849; approval date: 10/06/2020). | PMC9964898 |
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Informed Consent Statement | Not applicable. | PMC9964898 |
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Data Availability Statement | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC9964898 |
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Conflicts of Interest | The authors declare no conflict of interest. | PMC9964898 |
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Background | fracture, pain | Preoperative analgesia of hip fracture in elderly patients is important, but it is also lacking. In particular, nerve block was not provided in time. In order to provide more effective analgesia, we designed a multimodal pain management mode based on instant messaging software. | PMC10061705 |
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Methods | fascia iliaca compartment block, fracture, closed-loop pain, pain | MAY | From May to September 2022, a total of 100 patients with unilateral hip fracture aged over 65 were randomly divided into the test group and the control group. Finally, 44 patients in each group completed the result analysis. A new pain management mode was used in the test group. This mode focuses on the full information exchange between medical personnel in different departments, early fascia iliaca compartment block (FICB), and closed-loop pain management. Outcomes include the time when FICB is completed for the first time; The number of cases of FICB completed by emergency doctors; Patients' pain score, pain duration. | PMC10061705 |
Results | The time for patients in the test group to complete FICB for the first time was 3.0 [1.925–3.475] h, which was less than the time for patients in the control group (4.0 [3.300–5.275] h). The difference was statistically significant ( | PMC10061705 |
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Conclusions | pain | Using instant messaging software, the new model of pain management can enable patients to receive FICB as soon as possible and improve the timeliness and effectiveness of analgesia. | PMC10061705 |
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Trial registration | Chinese Clinical Registry Center, ChiCTR2200059013, 23/04/2022. | PMC10061705 |
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Keywords | PMC10061705 |
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Introduction | Pain, fracture, pain, fractures, trauma | Hip fracture is a common fracture in elderly patients and is the main cause of serious morbidity in elderly individuals aged 65 years and above [Pain management is particularly challenging in elderly patients in acute trauma settings [At present, several studies have shown that the multidisciplinary cooperation analgesic mode has played a great role in the perioperative pain management of hip fractures [To improve the preoperative analgesia of elderly patients with hip fractures, we plan to implement an interdisciplinary analgesic mode. The purpose of the new mode is to advance the implementation time of nerve block analgesia and improve pain management by increasing communication between different departments. We designed a randomized controlled trial to determine the role of this new management method in the early analgesia of elderly hip fracture patients. | PMC10061705 |
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Methods | PMC10061705 |
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Study design and ethics | This study was designed as a prospective parallel-group randomized controlled trial and conducted at Shengjing Hospital. The investigation was approved by the Institutional Review Board of Shengjing Hospital, China Medical University (approval number 2021PS511K, dated 12/05/2021). The trial was registered with the Chinese Clinical Registry Center (registration No. ChiCTR2200059013, dated 23/04/2022) before patient enrolment. Written informed consent was obtained from all subjects participating in the trial. The trial protocol followed the Declaration of Helsinki. This manuscript adheres to the applicable Consolidated Standards of Reporting Trials (CONSORT) guidelines. | PMC10061705 |
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Inclusion and exclusion criteria | delirium, bleeding, fracture, allergy, opioid addiction, fractures, trauma | BLEEDING, COAGULATION DISORDERS, GASTROINTESTINAL ULCERS, ALLERGY, SITE INFECTION | Inclusion criteria: patients aged ≥ 65 years with unilateral hip fracture who were admitted to our emergency department and were willing to undergo surgical repair.Exclusion criteria: multiple trauma or multiple fractures, coagulation disorders, gastrointestinal ulcers or bleeding, puncture site infections, history of allergy to local anaesthetics, opioid addiction, inability to communicate or score properly, presence of delirium, participation in other clinical trials. | PMC10061705 |
Randomization and blinding | In this parallel double-blind trial, the computer-generated random allocation sequence was created by an independent investigator using SPSS Statistics (version 24.0, IBM Corp., Armonk, NY, USA) with a 1:1 allocation and random block size. After providing written informed consent, the eligible patients were entered into the trial within 2 h of the emergency visit and were randomized into the trial and control groups using sealed opaque envelopes to reveal the treatment arm. None of the patients or data collectors were aware of the grouping. | PMC10061705 |
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Interventions | PMC10061705 |
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Test group | Pain, allergy, pain, NRS, trauma | ALLERGY, DISEASES | The core aim of the new pain relief management mode is to establish a pain management group composed of medical personnel from the emergency department, orthopaedics department and anaesthesiology department. Members of the working group have received unified training on the new pain relief mode.The communication within the group is through instant messaging software. All the accounts of the working group are public. The doctors on duty in each department swill log in to the account to join the working group during working hours and see past data and real-time information on their smartphones, computers and other devices. The data in the working group do not include private data other than the patient's medical information and will be completely cleared before the patient is discharged.1. Admission evaluation: The emergency medical staff will conduct the first comprehensive evaluation after the patient is admitted to the hospital and will send the evaluation results (general information of the patient, trauma, numerical rating scale [NRS] score, coexisting diseases, history of past illness and allergy history) to the working group.2. Analgesic scheme: All patients will be given a multimodal analgesic scheme before the operation. The basic analgesia is flurbiprofen axetil administered for 12 h. The affected side will be treated with 0.25% ropivacaine for fascia iliaca compartment block (FICB). The interval between two blocking operations should not be less than 8 h. After the completion of FICB, when the patient's pain NRS score is still > 3, he or she will take one tablet of oxycodone and acetaminophen orally.3. FICB: FICB will be implemented as soon as conditions permit. FICB can be completed by any doctor familiar with the operation, such as an emergency department physician or anaesthesiologist. During the operation, the ultrasound images of patients will also be shared in the working group in real time, and other doctors familiar with the FICB operation will also conduct remote guidance and consultation.4. Pain self-assessment: Educate patients on how to correctly use the NRS to assess their pain level. The NRS describes the pain intensity on a scale of 11 points that increase from 0 to 10. The specific scores are as follows: 0 indicates no pain, 1–3 indicates mild pain, 4–6 indicates moderate pain, 7–9 indicates severe pain, and 10 indicates the most severe pain. Patients with an NRS score of > 3 points can inform doctors to seek additional analgesic treatment.5. Pain closed-loop management: The dosage and effect of FICB for each patient are used as a reference for continuous treatment, and the information is stored as a case in the shared document of the working group. The changes in patients' pain scores and the additional use of oral analgesics will be recorded and summarized, the changes in the patients' pain will be tracked, and these data will be published to the working group. For patients with high pain scores, intragroup consultation will be conducted to consider increasing the concentration or dose of drugs in the next FICB. | PMC10061705 |
Control group | fracture, Pain | In this study, each patient's analgesia was directed by the doctor in his or her department, and other departments were invited to consult if necessary.1. Admission evaluation: The emergency medical staff carried out the first comprehensive evaluation after the patient was admitted to the hospital, and the contents were the same as those of the test group.2. Analgesic scheme: This scheme was the same as that in the test group.3. FICB: This was performed when the emergency or orthopaedic doctor considered it necessary or had asked the anaesthesiologist for a consultation.4. Pain self-assessment: This was consistent with the guidance provided to the test group.After participating in the trial, those patients who entered the intensive care unit preoperatively were excluded. Patients who ultimately did not undergo surgery were excluded from the trial. Patients with unplanned surgery during this hospitalization, that is, any surgery except for a single hip fracture surgery (including internal fixation and total/half hip replacement), were excluded.The anaesthesia method was not limited during the operation, and the postoperative analgesia scheme comprised a single FICB and an intravenous analgesia pump containing sufentanil. | PMC10061705 |
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Outcome measurements | Confusion, postoperative delirium, NRS, pain |
1. Time from the emergency room visit to the completion of FICB.2. Number of FICB completed by emergency physicians.3. The maximum NRS, the duration of the maximum NRS, and the duration of NRS > 3 were recorded.4. Analgesic satisfaction score. Patients were given a satisfaction score for preoperative analgesia before the procedure using a 5-point Likert scale from 1 to 5, ranging from complete disagreement to complete agreement, with higher scores indicating greater satisfaction with pain control.5. Incidence of postoperative delirium (POD) in the first 7 days postoperatively. Daily Confusion Assessment Method (CAM) scores were assessed by a blinded assessor in a face-to-face assessment [ | PMC10061705 |
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Statistical analysis | PMC10061705 |
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Sample size calculations | The main aim of this study was to compare the first FICB times. Based on the results of the pretest, we assumed that the first FICB timepoint for the test group was 3.0 h and that for the control group was 4.0 h, both with a standard deviation of 1.5. To obtain a statistical power of 90% (β = 0.1) with a two-sided confidence interval of 95% (α = 0.05), we used PASS11 for calculations with a sample size of 80 patients (40 in each group). The study planned to recruit an additional 10% of patients to account for potential loss to follow-up and withdrawals. | PMC10061705 |
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Statistical methods | SPSS 24 software was used for statistical analysis. The distribution of continuous variables was tested for normality using Shapiro‒Wilk tests. Normally distributed data were expressed as the mean ± standard deviation (SD), while nonnormally distributed data were expressed as the median (interquartile range [IQR]). Count data were expressed as numbers. The between-group comparison was performed using an independent t test for normally distributed measurement data and the Mann‒Whitney U test for nonnormally distributed measurement data. Count data were compared using a Pearson chi-square test or Fisher’s exact test. The data were compared using a Pearson chi-square test or Fisher’s exact test.Intention to treat (ITT) was used in this study. Because in the actual clinical work, the medical staff treating the patients in the control group may have received training on the new mode. Inevitably, the medical staff cannot completely reject the new mode in the process of treatment. Therefore, we will use ITT, that is, analysis based on intention to treat (i.e., planned grouping), rather than actual treatment. | PMC10061705 |
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Discussion | delirium, fracture, pain, attention disorders, fractures, mental disorder, NRS, nerve block | POSTOPERATIVE COMPLICATION | The results of this study showed that compared with the control group, the patients in the test group received FICB earlier, and their satisfaction with analgesia was improved. The maximum NRS of patients in the test group was lower, and the duration of the maximum NRS and duration of NRS > 3 was shorter.It has been widely recognized that the perioperative management of hip fractures, especially pain management, requires multidisciplinary cooperation. In this study, the results of the new mode of pain management were better than those of the control group. The primary reason for this is multidisciplinary cooperation. Multidisciplinary collaborative management for elderly hip fracture patients should involve the participation of emergency doctors, anaesthesiologists and orthopaedic doctors. Its contents include standardized first-aid procedures, comprehensive analgesic programmes, preoperative evaluation and treatment, early surgery and early discharge [Sufficient information exchange and feedback between different departments is the core of the new mode. With the progress of information science and technology, medical informatization has gradually become an important development trend. As a widely used information medium, instant messaging software provides users with more rapid, convenient and comprehensive cross-platform support. It has the characteristics of interactivity and immediacy. Using the universality of the network to promote the exchange and transmission of information, such software can meet the needs of users for instant information, provide a communication platform for team information communication, and make people's communication no longer limited by time, geographical location and space.With the help of instant messaging software, medical personnel participating in preoperative pain management can share information, communicate fully, give feedback in a timely manner and make common progress. The timeliness of information exchange makes the formulation and adjustment of analgesic programme more efficient and effective. The individualized analgesic programme can improve the level of pain management and patient satisfaction. Especially in FICB operation, the operator can live broadcast the real-time picture of puncture in software video, including the operator's specific actions and ultrasound images. In cases of a difficult procedure where the operator is not skilled enough, other doctors can remotely guide the operator to complete the block in real time to improve the success rate. In this study, the experimental group completed FICB earlier, which is precisely because of this approach.At the same time, under the new mode, medical staff are more familiar with patient information, especially when transferring them from the emergency department to the orthopaedics department. Medical staff have enough knowledge of the general situation and analgesia status of the patients, which will make patients feel more at ease and increase their overall satisfaction.The new mode in this study showed a better analgesic effect, which was directly due to the early implementation of FICB.A nerve block is an important part of the treatment plan for hip fracture patients and a key factor for success. Many previous studies have confirmed that single nerve block, especially FICB technology, has shown good analgesic effects in the preoperative analgesia of hip fracture in prehospital emergency settings and in emergency rooms [Adequate analgesia can reduce the incidence of POD in elderly patients. POD is an important factor affecting the prognosis of elderly patients. POD is an acute and reversible mental disorder characterized by changes in the level of consciousness and attention disorders after surgery and is a common postoperative complication of the central nervous system in elderly patients [This study attempted to determine the preventive effect of preoperative analgesia on POD. The MMSE scale was used to compare the cognitive function of the two groups of patients when they were admitted to the hospital because cognitive function change is an independent risk factor for delirium after orthopaedic surgery in the elderly [ | PMC10061705 |
Limitations |
1. There was no difference in the results of POD in this study. A large sample size will be used in future studies to determine the effect of preoperative analgesia on POD.2. In addition to POD, this study did not analyze the impact of prognostic indicators of patients under the new model. We look forward to finding the possible influence of analgesia mode on prognosis in future research.3. In the new mode, instant messaging software is used to enhance the convenience of information exchange, and attention should be given to protecting patient privacy and information security during use. We hope there will be specialized software in the future. | PMC10061705 |
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Conclusions | hip fracture, pain | For elderly patients with hip fracture, the new pain management mode, supported by instant messaging software, given full play to multidisciplinary cooperation and information exchange to complete FICB as soon as possible for efficient and effective analgesic treatment of patients. | PMC10061705 |