Noninferiority clinical trials are crucial for evaluating the effectiveness of new interventions compared to standard interventions. By establishing statistical and clinical comparability, these trials can be conducted to demonstrate that a new intervention is not significantly inferior to the standard intervention. However, selecting appropriate noninferiority margins and study designs are essential to ensuring valid and reliable results. Moreover, employing the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting noninferiority clinical trials enhances the quality and transparency of research findings. This article addresses key considerations and challenges faced by investigators in planning, conducting, and interpreting the results of noninferiority clinical trials.

Noninferiority clinical trials are crucial for evaluating the effectiveness of new interventions compared to standard interventions. By establishing statistical and clinical comparability, these trials can be conducted to demonstrate that a new intervention is not significantly inferior to the standard intervention. However, selecting appropriate noninferiority margins and study designs are essential to ensuring valid and reliable results. Moreover, employing the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting noninferiority clinical trials enhances the quality and transparency of research findings. This article addresses key considerations and challenges faced by investigators in planning, conducting, and interpreting the results of noninferiority clinical trials.

Noninferiority clinical trials are crucial for evaluating the effectiveness of new interventions compared to standard interventions. By establishing statistical and clinical comparability, these trials can be conducted to demonstrate that a new intervention is not significantly inferior to the standard intervention. However, selecting appropriate noninferiority margins and study designs are essential to ensuring valid and reliable results. Moreover, employing the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting noninferiority clinical trials enhances the quality and transparency of research findings. This article addresses key considerations and challenges faced by investigators in planning, conducting, and interpreting the results of noninferiority clinical trials.

Noninferiority clinical trials are crucial for evaluating the effectiveness of new interventions compared to standard interventions. By establishing statistical and clinical comparability, these trials can be conducted to demonstrate that a new intervention is not significantly inferior to the standard intervention. However, selecting appropriate noninferiority margins and study designs are essential to ensuring valid and reliable results. Moreover, employing the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting noninferiority clinical trials enhances the quality and transparency of research findings. This article addresses key considerations and challenges faced by investigators in planning, conducting, and interpreting the results of noninferiority clinical trials.

BACKGROUND: The trigeminocardiac reflex (TCR), which occurs after stimulation of the territory of the trigeminal nerve, is very rarely reported to be caused by stimulation of the mandibular branch. We report a case of TCR in open reduction for temporomandibular joint (TMJ) dislocation. CASE: A 74-year-old female presented for TMJ dislocation. During open reduction of TMJ under general anesthesia, severe bradycardia (15 beats/min) occurred. Immediately 0.5 mg atropine was administered intravenously, and the surgical manipulation was stopped. After 30 seconds, heart rate normalized. During surgery, severe bradycardia occurred one more time. It disappeared spontaneously as soon as surgical manipulation was stopped. The surgery was completed uneventfully. CONCLUSIONS: Because of the possibility of profound bradycardia, asystole, or even death when evoked, it is important to be aware of the trigeminocardiac reflex during manipulation of the mandibular divisions, especially during surgical stimulation of the TMJ.
Aged ; Anesthesia, General ; Atropine ; Bradycardia ; Dislocations ; Female ; Heart Arrest ; Heart Rate ; Humans ; Reflex, Trigeminocardiac ; Temporomandibular Joint ; Trigeminal Nerve

Regional anesthesia for non-obstetric surgery in parturients is a method to decrease patient and fetal risk during general anesthesia. Thoracic interfascial nerve block can be used as an analgesic technique for surgical procedures of the thorax. The Pecs II block is an interfascial block that targets not only the medial and lateral pectoral nerves, but also the lateral cutaneous branch of the intercostal nerve. Pecto-intercostal fascial block (PIFB) targets the anterior cutaneous branch of the intercostal nerve. The authors successfully performed a modified Pecs II block and PIFB without complications in a parturient who refused general anesthesia for breast surgery.
Anesthesia, Conduction ; Anesthesia, General ; Breast* ; Female ; Humans ; Intercostal Nerves ; Methods ; Nerve Block* ; Pregnant Women* ; Thoracic Nerves ; Thorax

Regional anesthesia for non-obstetric surgery in parturients is a method to decrease patient and fetal risk during general anesthesia. Thoracic interfascial nerve block can be used as an analgesic technique for surgical procedures of the thorax. The Pecs II block is an interfascial block that targets not only the medial and lateral pectoral nerves, but also the lateral cutaneous branch of the intercostal nerve. Pecto-intercostal fascial block (PIFB) targets the anterior cutaneous branch of the intercostal nerve. The authors successfully performed a modified Pecs II block and PIFB without complications in a parturient who refused general anesthesia for breast surgery.
Anesthesia, Conduction ; Anesthesia, General ; Breast* ; Female ; Humans ; Intercostal Nerves ; Methods ; Nerve Block* ; Pregnant Women* ; Thoracic Nerves ; Thorax

OBJECTIVES: Current treatments for osteoporosis were prevention of progression, yet it has been questionable in the stimulation of bone growth. The mesenchymal stem cells (MSCs) treatment for osteoporosis aims to induce differentiation of bone progenitor cells into bone-forming osteoblasts. We investigate whether human umbilical cord blood (hUCB)-MSCs transplantation may induce bone regeneration for osteoporotic rat model induced by ovariectomy. METHODS: The ovariectomized (OVX) group (n = 10) and OVX-MSCs group (n = 10) underwent bilateral ovariectomy to induce osteoporosis, while the Sham group (n = 10) underwent sham operation at aged 12 weeks. After a femoral defect was made at 9 months, Sham group and OVX group were injected with Hartmann solution, while the OVX-MSCs group was injected with Hartmann solution containing 1 × 107 hUCB-MSCs. The volume of regenerated bone was evaluated using micro-computed tomography at 4 and 8 weeks postoperation. RESULTS: At 4- and 8-week postoperation, the OVX group (5.0% ± 1.5%; 6.1% ± 0.7%) had a significantly lower regenerated bone volume than the Sham group (8.6% ± 1.3%; 12.0% ± 1.8%, P < 0.01), respectively. However, there was no significant difference between the OVX-MSCs and Sham groups. The OVX-MSCs group resulted in about 53% and 65% significantly higher new bone formation than the OVX group (7.7% ± 1.9%; 10.0% ± 2.9%, P < 0.05). CONCLUSIONS: hUCB-MSCs in bone defects may enhance bone regeneration in osteoporotic rat model similar to nonosteoporotic bone regeneration. hUCB-MSCs may be a promising alternative stem cell therapy for osteoporosis.
Animals ; Bone Development ; Bone Regeneration ; Female ; Fetal Blood ; Humans ; Mesenchymal Stem Cell Transplantation ; Mesenchymal Stromal Cells ; Models, Animal ; Osteoblasts ; Osteogenesis ; Osteoporosis ; Ovariectomy ; Rats ; Stem Cells ; Umbilical Cord

BACKGROUND: Although case reports have suggested that the erector spinae plane block (ESPB) may help analgesia for patients after breast surgery, no study to date has assessed its effectiveness. This retrospective observational study analyzed the analgesic effects of the ESPB after total mastectomy. METHODS: Forty-eight patients were divided into an ESPB group (n = 20) and a control group (n = 28). Twenty patients in the control group were selected by their propensity score matching the twenty patients in the ESPB group. Patients in the ESPB group were injected with 30 mL 0.375% ropivacaine, followed by catheter insertion for further injections of local anesthetics every 12 hours. Primarily, total fentanyl consumption was compared between the two groups during the first 24 hours postoperatively. Secondary outcomes included pain intensity levels (visual analogue scale) and incidence of postoperative nausea and vomiting (PONV). RESULTS: Median cumulative fentanyl consumption during the first 24 hours was significantly lower in the ESPB (33.0 μg; interquartile range [IQR], 27.0–69.5 μg) than in the control group (92.8 μg; IQR, 40.0–155.0 μg) (P = 0.004). Pain level in the early postoperative stage (<3 hr) and incidence of PONV (0% vs. 55%) were also significantly lower in the ESPB group compared to the control (P = 0.001). CONCLUSIONS: Intermittent ESPB after total mastectomy reduces fentanyl consumption and early postoperative pain. ESPB is a good option for multimodal analgesia after breast surgery.
Acute Pain ; Analgesia ; Anesthesia, Conduction ; Anesthetics, Local ; Breast ; Catheters ; Fentanyl ; Humans ; Incidence ; Mastectomy ; Mastectomy, Simple ; Nerve Block ; Observational Study ; Pain, Postoperative ; Postoperative Nausea and Vomiting ; Propensity Score ; Retrospective Studies ; Ultrasonography

Fascial plane blocks are useful for multimodal analgesia after cardiac surgery since they can provide effective analgesia without the serious risks associated with conventional techniques such as neuraxial hematoma and pneumothorax. This narrative review covers blocks performed at the parasternal intercostal, interpectoral, pectoserratus, serratus anterior, erector spinae, and retrolaminar planes, which are targets for fascial plane blocks in cardiac surgery. Brief anatomical considerations, mechanisms, and currently available evidence are reviewed. Additionally, recent evidence on fascial plane blocks for subcutaneous-implantable cardioverter-defibrillator implantation are also reviewed.