Recovery quality of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery: A randomized trial.

This study aimed to investigate the effect of liposomal bupivacaine in transversus abdominis plane block (TAP) on recovery quality after cesarean delivery. A randomized trial. An operating room, a post-anesthesia care unit, and a hospital ward. A total of 147 women scheduled for cesarean delivery under spinal anesthesia were enrolled and randomized to receive a TAP block with plain bupivacaine (bupivacaine group), liposomal bupivacaine (liposomal group), or a mixture of plain bupivacaine and liposomal bupivacaine (mixture group). The bupivacaine group received bilateral TAP blocks with plain bupivacaine 50 mg alone. The liposomal group received bilateral TAP blocks with liposomal bupivacaine 266 mg alone. The mixture group received bilateral TAP blocks with plain bupivacaine 50 mg followed by liposomal bupivacaine 266 mg. The primary outcome was the Quality of Recovery-15 (QoR - 15) score assessed 24 h postoperatively. Secondary outcomes encompassed the QoR - 15 score at 48 h post-surgery, the VAS pain score at rest and with movement at 24, 48, and 72 h postoperatively, opioid consumption within the 0-24 h and 24-48 h periods following surgery, as well as patient's satisfaction with analgesic. The QoR - 15 score at 24 h postoperatively was significantly higher in both the liposomal group and the mixture group compared to the bupivacaine group. Specifically, the QoR - 15 score for the liposomal group versus the bupivacaine group (median [IQR]: 120 [107, 128] vs. 109 [104, 120]; median difference, 7; 95 % CI, 2 to 13; P = 0.011) and for the mixture group versus the bupivacaine group (median [IQR]: 122 [112, 128] vs. 109 [104, 120]; median difference, 9; 95 % CI, 4 to 14; P = 0.001). The QoR - 15 score in both the liposomal group and the mixture group were also higher than those in the bupivacaine group at 48 h postoperatively, though the difference was not clinically meaningful. Additionally, both the liposomal and mixture groups exhibited lower pain score at 24 h and 48 h postoperatively compared to the bupivacaine group, but no significant clinical differences were achieved in either pain scores or opioid consumption. Patients in both the liposomal and mixture groups reported higher satisfaction score with analgesia than those in the bupivacaine group. TAP block using either liposomal bupivacaine or a mixture of plain bupivacaine and liposomal bupivacaine provided superior quality of recovery at 24 h after cesarean delivery compared to using plain bupivacaine alone.

Liu HH ，Qiu D ，Xu DR ，Yang JJ ，Teng PL ... -  《-》

Comparison of Two Modern Survival Prediction Tools, SORG-MLA and METSSS, in Patients With Symptomatic Long-bone Metastases Who Underwent Local Treatment With Surgery Followed by Radiotherapy and With Radiotherapy Alone.

Survival estimation for patients with symptomatic skeletal metastases ideally should be made before a type of local treatment has already been determined. Currently available survival prediction tools, however, were generated using data from patients treated either operatively or with local radiation alone, raising concerns about whether they would generalize well to all patients presenting for assessment. The Skeletal Oncology Research Group machine-learning algorithm (SORG-MLA), trained with institution-based data of surgically treated patients, and the Metastases location, Elderly, Tumor primary, Sex, Sickness/comorbidity, and Site of radiotherapy model (METSSS), trained with registry-based data of patients treated with radiotherapy alone, are two of the most recently developed survival prediction models, but they have not been tested on patients whose local treatment strategy is not yet decided. (1) Which of these two survival prediction models performed better in a mixed cohort made up both of patients who received local treatment with surgery followed by radiotherapy and who had radiation alone for symptomatic bone metastases? (2) Which model performed better among patients whose local treatment consisted of only palliative radiotherapy? (3) Are laboratory values used by SORG-MLA, which are not included in METSSS, independently associated with survival after controlling for predictions made by METSSS? Between 2010 and 2018, we provided local treatment for 2113 adult patients with skeletal metastases in the extremities at an urban tertiary referral academic medical center using one of two strategies: (1) surgery followed by postoperative radiotherapy or (2) palliative radiotherapy alone. Every patient's survivorship status was ascertained either by their medical records or the national death registry from the Taiwanese National Health Insurance Administration. After applying a priori designated exclusion criteria, 91% (1920) were analyzed here. Among them, 48% (920) of the patients were female, and the median (IQR) age was 62 years (53 to 70 years). Lung was the most common primary tumor site (41% [782]), and 59% (1128) of patients had other skeletal metastases in addition to the treated lesion(s). In general, the indications for surgery were the presence of a complete pathologic fracture or an impending pathologic fracture, defined as having a Mirels score of ≥ 9, in patients with an American Society of Anesthesiologists (ASA) classification of less than or equal to IV and who were considered fit for surgery. The indications for radiotherapy were relief of pain, local tumor control, prevention of skeletal-related events, and any combination of the above. In all, 84% (1610) of the patients received palliative radiotherapy alone as local treatment for the target lesion(s), and 16% (310) underwent surgery followed by postoperative radiotherapy. Neither METSSS nor SORG-MLA was used at the point of care to aid clinical decision-making during the treatment period. Survival was retrospectively estimated by these two models to test their potential for providing survival probabilities. We first compared SORG to METSSS in the entire population. Then, we repeated the comparison in patients who received local treatment with palliative radiation alone. We assessed model performance by area under the receiver operating characteristic curve (AUROC), calibration analysis, Brier score, and decision curve analysis (DCA). The AUROC measures discrimination, which is the ability to distinguish patients with the event of interest (such as death at a particular time point) from those without. AUROC typically ranges from 0.5 to 1.0, with 0.5 indicating random guessing and 1.0 a perfect prediction, and in general, an AUROC of ≥ 0.7 indicates adequate discrimination for clinical use. Calibration refers to the agreement between the predicted outcomes (in this case, survival probabilities) and the actual outcomes, with a perfect calibration curve having an intercept of 0 and a slope of 1. A positive intercept indicates that the actual survival is generally underestimated by the prediction model, and a negative intercept suggests the opposite (overestimation). When comparing models, an intercept closer to 0 typically indicates better calibration. Calibration can also be summarized as log(O:E), the logarithm scale of the ratio of observed (O) to expected (E) survivors. A log(O:E) > 0 signals an underestimation (the observed survival is greater than the predicted survival); and a log(O:E) < 0 indicates the opposite (the observed survival is lower than the predicted survival). A model with a log(O:E) closer to 0 is generally considered better calibrated. The Brier score is the mean squared difference between the model predictions and the observed outcomes, and it ranges from 0 (best prediction) to 1 (worst prediction). The Brier score captures both discrimination and calibration, and it is considered a measure of overall model performance. In Brier score analysis, the "null model" assigns a predicted probability equal to the prevalence of the outcome and represents a model that adds no new information. A prediction model should achieve a Brier score at least lower than the null-model Brier score to be considered as useful. The DCA was developed as a method to determine whether using a model to inform treatment decisions would do more good than harm. It plots the net benefit of making decisions based on the model's predictions across all possible risk thresholds (or cost-to-benefit ratios) in relation to the two default strategies of treating all or no patients. The care provider can decide on an acceptable risk threshold for the proposed treatment in an individual and assess the corresponding net benefit to determine whether consulting with the model is superior to adopting the default strategies. Finally, we examined whether laboratory data, which were not included in the METSSS model, would have been independently associated with survival after controlling for the METSSS model's predictions by using the multivariable logistic and Cox proportional hazards regression analyses. Between the two models, only SORG-MLA achieved adequate discrimination (an AUROC of > 0.7) in the entire cohort (of patients treated operatively or with radiation alone) and in the subgroup of patients treated with palliative radiotherapy alone. SORG-MLA outperformed METSSS by a wide margin on discrimination, calibration, and Brier score analyses in not only the entire cohort but also the subgroup of patients whose local treatment consisted of radiotherapy alone. In both the entire cohort and the subgroup, DCA demonstrated that SORG-MLA provided more net benefit compared with the two default strategies (of treating all or no patients) and compared with METSSS when risk thresholds ranged from 0.2 to 0.9 at both 90 days and 1 year, indicating that using SORG-MLA as a decision-making aid was beneficial when a patient's individualized risk threshold for opting for treatment was 0.2 to 0.9. Higher albumin, lower alkaline phosphatase, lower calcium, higher hemoglobin, lower international normalized ratio, higher lymphocytes, lower neutrophils, lower neutrophil-to-lymphocyte ratio, lower platelet-to-lymphocyte ratio, higher sodium, and lower white blood cells were independently associated with better 1-year and overall survival after adjusting for the predictions made by METSSS. Based on these discoveries, clinicians might choose to consult SORG-MLA instead of METSSS for survival estimation in patients with long-bone metastases presenting for evaluation of local treatment. Basing a treatment decision on the predictions of SORG-MLA could be beneficial when a patient's individualized risk threshold for opting to undergo a particular treatment strategy ranged from 0.2 to 0.9. Future studies might investigate relevant laboratory items when constructing or refining a survival estimation model because these data demonstrated prognostic value independent of the predictions of the METSSS model, and future studies might also seek to keep these models up to date using data from diverse, contemporary patients undergoing both modern operative and nonoperative treatments. Level III, diagnostic study.

Lee CC ，Chen CW ，Yen HK ，Lin YP ，Lai CY ，Wang JL ，Groot OQ ，Janssen SJ ，Schwab JH ，Hsu FM ，Lin WH ... -  《-》

Comparison of erector spinae plane block and transverse abdominis plane block in postoperative recovery after laparoscopic colorectal surgery: a randomized, double-blind, controlled trial.

Patients experience significant postoperative pain after laparoscopic resection of colorectal cancer. Transversus abdominis plane block (TAPB) provides effective analgesia, and recent studies have also shown that erector spinae plane block (ESPB) can be used for postoperative analgesia in abdominal surgery. However, there is a lack of comparison between the two methods regarding recovery quality following laparoscopic colorectal surgery. Sixty patients scheduled for laparoscopic radical resection of colorectal cancer were randomly assigned to receive either a ESPB with TAPB (n = 30). Both groups received a single injection of 20 mL of 0.25% ropivacaine bilaterally. The primary outcome was the quality of recovery (QoR) at 24 h postoperatively, using the quality of recovery-15 (QoR-15) scale. Secondary outcomes included the QoR at 48 h postoperatively, visual analogue scale (VAS) pain scores during the first 48 h postoperatively in both resting and active states, requirements for rescue analgesia, cumulative postoperative opioid consumption, patient satisfaction, incidence of postoperative nausea and vomiting (PONV), time to first flatus and ambulation, the Comprehensive Complication Index (CCI) score, and postoperative hospital stay. At 24 h postoperatively, the QoR-15 score (mean ± standard deviation) was significantly higher in the ESPB group (109.2 ± 8.7) compared to the TAPB group (101 ± 10.1) (p = 0.001). Similarly, at 48 h postoperatively, the QoR-15 score remained higher in the ESPB group (118.5 ± 8.8) than in the TAPB group (113.8 ± 8.1) (p = 0.035). Patients in the ESPB group reported lower visual analog scale (VAS) pain scores during the first 24 h postoperatively (all p < 0.05) compared to those in the TAPB group. The sufentanil consumption median (interquartile range) in the ESPB group at 24 h postoperatively was lower (62, 61-65 μg) compared to the TAPB group (66, 63-70 μg) (p < 0.001). Hospital stay median was 7 (6-9) days for the ESPB group and 8 (7-10) days for the TAPB group (p = 0.037). Patients who received ESPB showed better recovery quality, improved analgesic effects, and higher postoperative satisfaction compared to those who underwent preoperative TAPB. https://www.chictr.org.cn (ChiCTR2400081157); date of registration: February 24, 2024. The first participant was enrolled on February 27, 2024.

Hou P ，Liu W ，Chen R ，Mi H ，Jia S ，Lin J ... -  《-》

A Randomized Controlled Trial of a Novel Formulation of Ketorolac Tromethamine for Continuous Infusion (NTM-001) in Healthy Volunteers.

Pergolizzi JV Jr ，Batra A ，Schmidt WK 《-》

Enhancing Postoperative Analgesia After Cesarean Section: Insights Into Transversus Abdominis Plane Block, Intrathecal Opioids, and Other Analgesic Techniques.

Cesarean section (CS) is associated with moderate to severe pain that may delay recovery and interfere with the mother's ability to take care of the newborn. This clinical study aimed to evaluate different analgesic protocols for postoperative pain management after CS. The study included 300 parturients scheduled for CS and classified into five equal groups as follows: general anesthesia (GA group), GA plus transversus abdominis plane (TAP) block (GA+TAP group), spinal anesthesia (SA) plus intrathecal fentanyl (ITF group), SA plus fentanyl + TAP block (ITF+TAP group), and SA plus intrathecal morphine (ITM group). Multimodal analgesia was added to all groups in the form of paracetamol 1 g/6 hours intravenously (IV), lornoxicam (8 mg/8 hours/IV), in addition to rescue opioid analgesia (morphine or oxycodone 4 mg/IV) upon the patient's request. Primary outcomes included pain assessments by numerical rating scale (NRS), worst and least pain scores, and time in maximum pain. Secondary outcomes included time to first request of analgesia, total opioid consumption, patient request for additional analgesia, function, and satisfaction scores. Possible side effects and neonatal Apgar scores were recorded at five and 10 minutes. The results showed a significant difference between the study groups regarding pain relief. The best pain relief, lowest worst pain, least pain, and total opioid consumption were reported by the ITM group, followed by ITF+TAP, GA+TAP, then SA, and GA groups (p < 0.05). The lower percentage of time in the worst pain and the longest time to the first request of analgesia were reported with ITM and ITF+TAP groups followed by the ITF group and GA+TAP group. In contrast, the longest time spent in the worst pain and the shortest duration until the first request of analgesia was observed in the GA group (p < 0.05). The best function scores were observed with ITF+TAP and then ITM, while the highest satisfaction scores were reported with ITM, ITF+TAP followed by SA and GA+TAP, and the lowest scores were observed in the GA group (p < 0.001 and p < 0.005, respectively). Side effects such as itching, nausea, and vomiting were significantly higher in the ITM group when compared to the other groups (p < 0.05). There were no significant differences between the study groups regarding the Apgar scores at five and 10 minutes (p = 0.271 and 0.760). Bilateral TAP block has the potential to effectively enhance postoperative analgesia and reduce the need for systemic opioids after both GA and SA. Compared to ITF, ITM provides a higher quality and longer duration of analgesia with minimal analgesic-related side effects. Further studies to find an optimal analgesic protocol with few to no side effects are warranted.

El-Tallawy SN ，Pergolizzi JV ，Amlih HF ，Fairaq MM ，Awaleh FI ，Alsubaie AT ，Shaheen IS ，Al-Kayyal YS ，Ahmed RS ，Ali WA ... -  《Cureus》