American Society of Pain and Neuroscience Best Practice (ASPN) Guideline for the Treatment of Sacroiliac Disorders.

Clinical management of sacroiliac disease has proven challenging from both diagnostic and therapeutic perspectives. Although it is widely regarded as a common source of low back pain, little consensus exists on the appropriate clinical management of sacroiliac joint pain and dysfunction. Understanding the biomechanics, innervation, and function of this complex load bearing joint is critical to formulating appropriate treatment algorithms for SI joint disorders. ASPN has developed this comprehensive practice guideline to serve as a foundational reference on the appropriate management of SI joint disorders utilizing the best available evidence and serve as a foundational guide for the treatment of adult patients in the United States and globally.

The analgesic effectiveness of perioperative lidocaine infusions for acute and chronic persistent postsurgical pain in patients undergoing breast cancer surgery: a systematic review and meta-analysis.

BACKGROUND: Breast cancer is the most common cancer among women and tumour resection carries a high prevalence of chronic persistent postsurgical pain (CPSP). Perioperative i.v. lidocaine infusion has been proposed as protective against CPSP; however, evidence of its benefits is conflicting. This review evaluates the effectiveness of perioperative lidocaine infusions for breast cancer surgery. METHODS: Randomised trials comparing perioperative lidocaine infusions with parenteral analgesia in breast cancer surgery patients were sought. The two co-primary outcomes were the odds of CPSP at 3 and 6 months after operation. Secondary outcomes included rest pain at 1, 6, 12, and 24 h; analgesic consumption at 0-24 and 25-48 h; quality of recovery; opioid-related side-effects; and lidocaine infusion side-effects. Hartung-Knapp-Sidik-Jonkman (HKSJ) random effects modelling was used. RESULTS: Thirteen trials (1039 patients; lidocaine: 518, control: 521) were included. Compared with control, perioperative lidocaine infusion did not decrease the odds of developing CPSP at 3 and 6 months. Lidocaine infusion improved postoperative pain at 1 h by a mean difference (95% confidence interval) of -0.65 cm (-0.73 to -0.57 cm) (P<0.0001); however, this difference was not clinically important (1.1 cm threshold). Similarly, lidocaine infusion reduced oral morphine consumption by 7.06 mg (-13.19 to -0.93) (P=0.029) over the first 24 h only; however, this difference was not clinically important (30 mg threshold). The groups were not different for any of the remaining outcomes. CONCLUSIONS: Our results provide moderate-quality evidence that perioperative lidocaine infusion does not reduce CPSP in patients undergoing breast cancer surgery. Routine use of lidocaine infusions for perioperative analgesia and CPSP prevention is not supported in this population. SYSTEMATIC REVIEW PROTOCOL: PROSPERO CRD42023420888.

Incidence of subsequent surgical decompression following minimally invasive approaches to treat lumbar spinal stenosis: A retrospective review.

BACKGROUND CONTEXT: Surgical decompression is the definitive treatment for managing symptomatic lumbar spinal stenosis; however, select patients are poor surgical candidates. Consequently, minimally invasive procedures have gained popularity, but there exists the potential for failure of therapy necessitating eventual surgical decompression. PURPOSE: To evaluate the incidence and characteristics of patients who require surgical decompression following minimally invasive procedures to treat lumbar spinal stenosis. STUDY DESIGN/SETTING: Retrospective review. PATIENT SAMPLE: Patients who underwent minimally invasive procedures for lumbar spinal stenosis (Percutaneous Image-guided Lumbar Decompression [PILD] or interspinous spacer device [ISD]) and progressed to subsequent surgical decompression within 5 years. OUTCOME MEASURES: The primary outcome was the rate of surgical decompression within 5 years following the minimally invasive approach. Secondary outcomes included demographic and comorbid factors associated with increased odds of requiring subsequent surgery. METHODS: Patient data were collected using the PearlDiver-Mariner database. The rate of subsequent decompression was described as a percentage while univariable and multivariable regression analysis was used for the analysis of predictors. RESULTS: A total of 5278 patients were included, of which 3222 (61.04%) underwent PILD, 1959 (37.12%) underwent ISD placement, and 97 (1.84%) had claims for both procedures. Overall, the incidence of subsequent surgical decompression within 5 years was 6.56% (346 of 5278 patients). Variables associated with a significantly greater odds ratio (OR) [95% confidence interval (CI)] of requiring subsequent surgical decompression included male gender and a prior history of surgical decompression by 1.42 ([1.14, 1.77], p = 0.002) and 2.10 times ([1.39, 3.17], p < 0.001), respectively. In contrast, age 65 years and above, a diagnosis of obesity, and a Charlson Comorbidity Index score of three or greater were associated with a significantly reduced OR [95% CI] by 0.64 ([0.50, 0.81], p < 0.001), 0.62 ([0.48, 0.81], p < 0.001), and 0.71 times ([0.56, 0.91], p = 0.007), respectively. CONCLUSIONS: Minimally invasive procedures may provide an additional option to treat symptomatic lumbar spinal stenosis in patients who are poor surgical candidates or who do not desire open decompression; however, there still exists a subset of patients who will require subsequent surgical decompression. Factors such as gender and prior surgical decompression increase the likelihood of subsequent surgery, while older age, obesity, and a higher Charlson Comorbidity Index score reduce it. These findings aid in selecting suitable surgical candidates for better outcomes in the elderly population with lumbar spinal stenosis.

Wearable motion-based platform for functional spine health assessment.

INTRODUCTION: Low back pain is a significant burden to society and the lack of reliable outcome measures, combined with a prevailing inability to quantify the biopsychosocial elements implicated in the disease, impedes clinical decision-making and distorts treatment efficacy. This paper aims to validate the utility of a biopsychosocial spine platform to provide standardized wearable sensor-derived functional motion assessments to assess spine function and differentiate between healthy controls and patients. Secondarily, we explored the correlation between these motion features and subjective biopsychosocial measures. METHODS: An observational study was conducted on healthy controls (n=50) and patients with low back pain (n=50) to validate platform utility. The platform was used to conduct functional assessments along with patient-reported outcome assessments to holistically document cohort differences. Our primary outcomes were motion features; and our secondary outcomes were biopsychosocial measures (pain, function, etc). RESULTS: Our results demonstrated statistically significant differences in motion features between healthy and patient cohorts across anatomical planes. Importantly, we found velocity and acceleration in the axial plane showed the largest difference, with healthy controls having 49.7% and 55.7% higher values, respectively, than patients. In addition, we found significant correlations between motion features and biopsychosocial measures for pain, physical function and social role only. CONCLUSIONS: Our study validated the use of wearable sensor-derived functional motion metrics in differentiating healthy controls and patients. Collectively, this technology has the potential to facilitate holistic biopsychosocial evaluations to enhance spine care and improve patient outcomes. TRIAL REGISTRATION NUMBER: NCT05776771.

Neuromodulation for the Sphenopalatine Ganglion-a Narrative Review.

PURPOSE OF REVIEW: To provide an integrated overview of the current state of knowledge of neuromodulation for the sphenopalatine ganglion (SPG) by reviewing relevant and significant literature. RECENT FINDINGS: There are several case reports and clinical trials evaluating neuromodulation for the SPG. We identified two blinded, randomized clinical trials for patients with chronic cluster headache. The randomized trials and additional studies demonstrated the long-term safety, efficacy, and cost-effectiveness of neuromodulation for the SPG. Recent studies in Europe and the USA suggest that SPG neuromodulation is a novel modality with clinical importance for treating acute cluster headaches and reducing the frequency of attacks.

Neuromodulation for Peripheral Nerve Regeneration: Systematic Review of Mechanisms and In Vivo Highlights.

While denervation can occur with aging, peripheral nerve injuries are debilitating and often leads to a loss of function and neuropathic pain. Although injured peripheral nerves can regenerate and reinnervate their targets, this process is slow and directionless. There is some evidence supporting the use of neuromodulation to enhance the regeneration of peripheral nerves. This systematic review reported on the underlying mechanisms that allow neuromodulation to aid peripheral nerve regeneration and highlighted important in vivo studies that demonstrate its efficacy. Studies were identified from PubMed (inception through September 2022) and the results were synthesized qualitatively. Included studies were required to contain content related to peripheral nerve regeneration and some form of neuromodulation. Studies reporting in vivo highlights were subject to a risk of bias assessment using the Cochrane Risk of Bias tool. The results of 52 studies indicate that neuromodulation enhances natural peripheral nerve regeneration processes, but still requires other interventions (e.g., conduits) to control the direction of reinnervation. Additional human studies are warranted to verify the applicability of animal studies and to determine how neuromodulation can be optimized for the greatest functional restoration.

Cognitive dissonance increases spine loading in the neck and low back.

Cognitive dissonance refers to a state where two psychologically inconsistent thoughts, behaviours, or attitudes are held at the same time. The objective of this study was to explore the potential role of cognitive dissonance in biomechanical loading in the low back and neck. Seventeen participants underwent a laboratory experiment involving a precision lowering task. To establish a cognitive dissonance state (CDS), study participants were provided negative feedback on their performance running counter to a pre-established expectation that their performance was excellent. Dependent measures of interest were spinal loads in the cervical and lumbar spines, calculated via two electromyography-driven models. The CDS was associated with increases to peak spinal loads in the neck (11.1%, p < .05) and low back (2.2%, p < .05). A greater CDS magnitude was also associated with a greater spinal loading increase. Therefore, cognitive dissonance may represent a risk factor for low back/neck pain that has not been previously identified.Practitioner summary: Upon establishing a cognitive dissonance state in a group of participants, spinal loading in the cervical and lumbar spines were increased proportional to the magnitude of the cognitive dissonance reported. Therefore, cognitive dissonance may represent a risk factor for low back and neck pain that has not been previously identified.

Identifying Predictors for Early Percutaneous Spinal Cord Stimulator Explant at One and Two Years: A Retrospective Database Analysis.

OBJECTIVES: Placement of percutaneous spinal cord stimulator (SCS) implant has become a therapeutic option for various chronic pain conditions; however, early surgical explant still occurs. Unfortunately, evidence regarding the incidence of early surgical explant, and patient-specific factors and comorbidities associated with such, is limited and mixed. The objective of this retrospective analysis was to elucidate the incidence and predictors of percutaneous SCS explant within the first two years of device placement. MATERIALS AND METHODS: The PearlDiver-Mariner Patient Record Database of all payer claims was used to identify patients who underwent percutaneous lead SCS implant (leads and generator) with subsequent explant within two years of initial device implant. The primary outcome was to determine the incidence of SCS explant within the first two years of device placement. Secondary outcomes included evaluating the effects of several patient-specific comorbidities on explant rates using univariate regression analysis. RESULTS: Across the database, a total of 52,070 patients who underwent percutaneous lead SCS implant were included, of whom 3104 (5.96%) had SCS explant within the first two years. Most explants occurred within the first-year time interval at 72.8% (2260 patients), whereas only 27.2% (844 patients) had SCS explant between years one and two. At the one-year time interval, covariates associated with an increased odds ratio (OR) (95% CI) of SCS explant were 1) depression (1.39 [1.26, 1.52]), 2) chronic preoperative (1.27 [1.16, 1.39]) or postoperative (1.23 [1,13, 1.36]) opioid use, 3) cannabis abuse (1.58 [1.20, 2.02]), 4) tobacco use (1.13 [1.04, 1.23]), and 5) coagulopathy (1.22 [1.07, 1.38]). In contrast, the OR of explant was lower in patients who were older, men, or had diabetes (complicated or uncomplicated). All associated covariates became nonsignificant after the first year of SCS implant (ie, between the first and second years), and only depression and tobacco use remained as associated factors for device explant. CONCLUSIONS: Our retrospective analysis highlights that the rate of percutaneous SCS explant appears to considerably decrease after the first year of device implant. Furthermore, this analysis sheds additional insights into patients who may be at risk of early percutaneous SCS explant, especially within the first year of device placement, and underscores the importance of a continued multidimensional/biopsychologic assessment in patients with chronic pain.

The role of neuroinflammation in the transition of acute to chronic pain and the opioid-induced hyperalgesia and tolerance.

Current evidence suggests that activation of glial and immune cells leads to increased production of proinflammatory mediators, creating a neuroinflammatory state. Neuroinflammation has been proven to be a fundamental mechanism in the genesis of acute pain and its transition to neuropathic and chronic pain. A noxious event that stimulates peripheral afferent nerve fibers may also activate pronociceptive receptors situated at the dorsal root ganglion and dorsal horn of the spinal cord, as well as peripheral glial cells, setting off the so-called peripheral sensitization and spreading neuroinflammation to the brain. Once activated, microglia produce cytokines, chemokines, and neuropeptides that can increase the sensitivity and firing properties of second-order neurons, upregulating the signaling of nociceptive information to the cerebral cortex. This process, known as central sensitization, is crucial for chronification of acute pain. Immune-neuronal interactions are also implicated in the lesser-known complex regulatory relationship between pain and opioids. Current evidence suggests that activated immune and glial cells can alter neuronal function, induce, and maintain pathological pain, and disrupt the analgesic effects of opioid drugs by contributing to the development of tolerance and dependence, even causing paradoxical hyperalgesia. Such alterations may occur when the neuronal environment is impacted by trauma, inflammation, and immune-derived molecules, or when opioids induce proinflammatory glial activation. Hence, understanding these intricate interactions may help in managing pain signaling and opioid efficacy beyond the classical pharmacological approach.

Efficacy of PECS block in addition to multimodal analgesia for postoperative pain management in patients undergoing outpatient elective breast surgery: A retrospective study.

Background: Pectoralis nerve blocks (PECS) have been shown in numerous studies to be a safe and effective method to treat postoperative pain and reduce postoperative opioid consumption after breast surgery. However, there are few publications evaluating the PECS block effectiveness in conjunction with multimodal analgesia (MMA) in outpatient breast surgery. This retrospective study aims to evaluate the efficacy of PECS's blocks on perioperative pain management and opioid consumption. Methods: We conducted a retrospective study to assess the efficacy of preoperative PECS block in addition to preoperative MMA (oral acetaminophen and/or gabapentin) in reducing opioid consumption in adult female subjects undergoing outpatient elective breast surgery between 2015 and 2020. A total of 228 subjects were included in the study and divided in two groups: PECS block group (received PECS block + MMA) and control Group (received only MMA). The primary outcome was to compare postoperative opioid consumption between both groups. The secondary outcome was intergroup comparisons of the following: postoperative nausea and vomiting (PONV), incidence of rescue antiemetic medication, PACU non-opioid analgesic medication required, length of PACU stay and the incidence of 30-day postoperative complications between both groups. Results: Two hundred and twenty-eight subjects (n = 228) were included in the study. A total of 174 subjects were allocated in the control group and 54 subjects were allocated in the PECS block group. Breast reduction and mastectomy/lumpectomy surgeries were the most commonly performed procedures (48% and 28%, respectively). The total amount of perioperative (intraoperative and PACU) MME was 27 [19, 38] in the control group and 28.5 [22, 38] in the PECS groups (p = 0.21). PACU opioid consumption was 14.3 [7, 24.5] MME for the control group and 17 [8, 23] MME (p = 0.732) for the PECS group. Lastly, the mean overall incidence of postsurgical complications at 30 days was 3% (N = 5), being wound infection, the only complication observed in the PECS groups (N = 2), and hematoma (N = 2) and wound dehiscence (N = 1) in the control group. Conclusion: PECS block combined with MMA may not reduce intraoperative and/or PACU opioid consumption in patients undergoing outpatient elective breast surgery.

The Potential Relationship Between a Cognitive Dissonance State and Musculoskeletal Injury: A Systematic Review.

OBJECTIVE: The objective of this systematic review was to investigate the potential link between cognitive dissonance or its related constructs (emotional dissonance, emotional labor) and musculoskeletal disorders. BACKGROUND: The etiology of musculoskeletal disorders is complex, as pain arises from complex interactions among physical, social, and psychological stressors. It is possible that the psychological factor of cognitive dissonance may contribute to the etiology and/or maintenance of musculoskeletal disorders. METHOD: MEDLINE, APA PsycInfo, and CINAHL Plus databases were searched for studies investigating cognitive dissonance or its related constructs as exposure(s) of interest and outcomes related to physical health (including, but not limited to, musculoskeletal pain). Risk of bias was assessed using the Appraisal tool for Cross-Sectional Studies (AXIS) tool. RESULTS: The literature search yielded 7 studies eligible for inclusion. None of the included studies investigated cognitive dissonance directly but instead investigated dissonance-related constructs of emotional dissonance and emotional labor, in which a mismatch between required and felt emotions might elicit a psychological response consistent with the cognitive dissonance state. Moderate effect sizes between dissonance-related constructs and musculoskeletal disorders were noted (OR 1.25-2.22). CONCLUSION: There is likely a relationship between the two factors studied. However, as the included studies were cross-sectional in nature, a causal relationship between cognitive dissonance-related constructs and musculoskeletal disorders cannot be inferred. Therefore, future study proposing and validating a causal pathway between these variables is warranted. APPLICATION: Cognitive dissonance and its related constructs may serve as risk factors for musculoskeletal disorders that have not been considered previously.

Incidence and Predictors of Inadvertent Dural Puncture After Percutaneous Spinal Cord Stimulation: A Retrospective Database Analysis.

OBJECTIVES: Inadvertent dural puncture (IDP) is a known complication associated with traditional neuraxial procedures; however, its characterization after percutaneous spinal cord stimulation (SCS) lead placement has yet to be clearly established in large population studies. This retrospective analysis aims to understand the incidence and associated characteristics of patients with IDP after percutaneous SCS lead placement. MATERIALS AND METHODS: The PearlDiver Mariner database of national all-payer claims was used to identify patients who received percutaneous SCS leads and had a claim for IDP (intraoperative IDP or postdural puncture headache [PDPH] claim) within 45 days. The primary outcome was to determine the overall incidence of IDP. Secondary outcomes included an evaluation of associated risk factors for IDP and treatments used in symptomatic management. RESULTS: A total of 90,952 patients who underwent percutaneous lead SCS placement were included. The incidence of IDP was 0.48% (436/90,952 patients). Older age (odds ratio [OR]: 0.96; 95% CI: 0.95-0.97; p < 0.0001) and male sex (OR: 0.66; 95% CI: 0.53-0.81; p < 0.001) had a lower odds of having a claim for IDP, whereas a history of IDP was associated with a higher OR (95% CI) by 13.72 times (10.72-17.58) (p < 0.0001). Of the IDP patients, 64% (277/436 patients) had a claim for a therapeutic blood patch. Discrepancy in type of claim for IDP was observed, with most being for PDPH. CONCLUSIONS: Our findings suggest that IDP after percutaneous SCS lead placement is an uncommon event; however, certain factors are associated with its development. Overall, early recognition of IDP after percutaneous SCS lead placement is imperative to facilitate the delivery of targeted treatments and prevent further harmful consequences to the patient.

Peripheral Nerve Stimulation for Lower Extremity Pain.

Peripheral nerve stimulation (PNS) is rapidly increasing in use. This interventional pain treatment modality involves modulating peripheral nerves for a variety of chronic pain conditions. This review evaluated its use specifically in the context of chronic lower extremity pain. Studies continue to elucidate the utility of PNS and better define indications, contraindications, as well as short- and long-term benefits of the procedure for the lower extremity. While large, prospective evidence is still lacking, the best available evidence suggests that improvements may be seen in pain scores, functionality, and opioid consumption. Overall, evidence synthesis suggests that PNS for the lower extremities may be a viable option for patients with chronic lower extremity pain.

Evaluating the incidence of spinal cord injury after spinal cord stimulator implant: an updated retrospective review.

INTRODUCTION: While spinal cord stimulator implant is an increasingly safe procedure, one of the most feared complications is spinal cord injury. Still, literature regarding its incidence remains highly variable. This retrospective analysis aims to evaluate the incidence of spinal cord injury after spinal cord stimulator implant using a large-scale claims database. METHODS: The PearlDiver-Mariner database of national all payer claims was used to identify patients who underwent spinal cord stimulator implant (percutaneous or paddle) and developed subsequent spinal cord injury within 45 days. The primary outcome was to determine the overall incidence of spinal cord injury after spinal cord stimulator implant. Secondary outcomes included an evaluation of potential factors associated with developing spinal cord injury using univariable and multivariable regression analysis. RESULTS: A total of 71,172 patients who underwent a spinal cord stimulator implant were included in the analysis, of which 52,070 underwent percutaneous and 19,102 underwent paddle spinal cord stimulator lead implant. The overall incidence of spinal cord injury after spinal cord stimulator implant (any lead type) was found to be 0.42% (302 patients). The incidence of spinal cord injury after percutaneous and paddle lead implants did not differ at 0.45% (233 patients) and 0.36% (69 patients)(p=0.12), respectively. Overall, variables associated with a significantly increased OR (95% confidence interval) of developing spinal cord injury included male gender by 1.31 times (1.04 to 1.65)(p=0.02); having a claim for low molecular weight heparin within 30 days by 3.99 times (1.47 to 10.82)(p<0.01); a diagnosis for osteoporosis within 1 year by 1.75 times (1.15 to 2.66)(p<0.01); and a diagnosis of cervical or thoracic spinal canal stenosis within 1 year by 1.99 (1.37 to 2.90)(p<0.001) and 4.00 (2.63 to 6.09)(p<0.0001) times, respectively. CONCLUSIONS: Overall, our results support the notion that spinal cord stimulator implant continues to be a safe procedure for chronic pain patients. However, risk factor mitigation strategies for the prevention of spinal cord injury after spinal cord stimulator implant should be undertaken prior to performing the procedure.

Perioperative subcutaneous methylnaltrexone does not enhance gastrointestinal recovery after posterior short-segment spinal arthrodesis surgery: a randomized controlled trial.

BACKGROUND CONTEXT: Postoperative ileus is a major barrier to gastrointestinal recovery following surgery. Opioid analgesics likely play an important causative role, particularly in spinal or orthopedic surgeries not involving bowel manipulation. Methylnaltrexone, a peripherally-acting µ-opioid receptor antagonist, is a potential prophylactic treatment. PURPOSE: To assess the influence of perioperative subcutaneous methylnaltrexone administration on gastrointestinal recovery following short-segment lumbar arthrodesis surgeries. DESIGN: This is a randomized, double-blind, controlled trial. PATIENT SAMPLE: Eligible patients undergoing posterior short-segment lumbar arthrodesis surgeries at a single institution between February 2019 and April 2021 were enrolled in this study. OUTCOME MEASURES: The primary outcome measure was time-to-first bowel movement. Secondary outcome measures included time-to-discharge/discharge eligibility. Exploratory outcome measures included daily postoperative opioid consumption and pain scores. METHODS: In this study, eligible patients were enrolled to receive either methylnaltrexone or placebo perioperatively. Time-to-bowel movement, time-to-discharge/discharge eligibility, intra and postoperative analgesic administration, and pain scores were recorded and compared. RESULTS: Eighty two patients in total were enrolled; 41 to the methylnaltrexone and 41 to the placebo group. Both groups were similar in their baseline characteristics. There was no difference in median (range) time-to-bowel movement between the 2 groups [61.8 hours (35.7-93.6) versus 50.7 hours (17.8-110.8), p = .391]. There was also no difference in time-to-discharge/discharge eligibility [105.0 hours (81.0 - 201.3) versus 90.7 (77.5 - 184.5), p=.784]. Finally, there were no differences in either postoperative opioid consumption or numeric rating scores for back, leg, or abdominal pain on postoperative days 0 to 4 (p>.05). CONCLUSIONS: Methylnaltrexone did not accelerate gastrointestinal recovery and did not affect opioid consumption or pain scores following short-segment spinal surgery as compared to placebo. Additional studies will be needed to identify effective opioid receptor antagonist dosing regimens for patients undergoing either short- or long-segment spinal arthrodesis procedures.

Neurofilament Levels in CSF and Serum in an Adult SMA Cohort Treated with Nusinersen.

OBJECTIVE: To retrospectively evaluate the utility of serum and cerebrospinal fluid (CSF) levels of neurofilament light chain (NfL) and phosphorylated neurofilament heavy chain (pNfH) as biomarkers for spinal muscular atrophy (SMA) progression and response to nusinersen treatment. METHODS: NfL and pNfH levels were quantified using single molecular array (SIMOA) in CSF of 33 adult SMA patients (SMN copy number 3-5) before and in response to nusinersen treatment. In 11 of the patients, blood serum samples were also collected. CSF NfL and pNfH from patients were compared to CSF Nfs from age-matched controls without neurological disease (n = 6). For patients, pearson correlation coefficients (r) were calculated to investigate associations between Nf levels and other functional outcome measures. RESULTS: Nf levels were similar between SMA and control adults and showed no change in response to nusinersen treatment in CSF or serum. Cross-sectional analyses showed an increase in CSF NfL and pNfH with age in patients (NfL p = 0.0013; pNfH p = 0.0035) and an increase in CSF NfL in controls (p = 0.002). In non-ambulatory patients, baseline serum pNfH showed a negative correlation with multiple strength and functional assessment metrics including Revised Upper Limb Module (r = -0.822, p = 0.04), upper extremity strength (r = -0.828, p = 0.042), lower extremity strength (r = -0.860, p = 0.028), and total strength (r = -0.870, p = 0.024). CONCLUSIONS: Nf levels did not change in response to nusinersen in adults with SMA and were not different from controls. In patients and controls, we detected an age-related increase in baseline CSF NfL and pNfH levels. Though some associations were identified, our results suggest Nf levels are not preditive or prognostic biomarkers in this population.

Design and feasibility of a double-blind, randomized trial of peri-operative methylnaltrexone for postoperative ileus prevention after adult spinal arthrodesis.

BACKGROUND: Postoperative ileus (POI) is a common complication with no proven prophylactic measures in place. While perioperative opioid use has been implicated in POI development, current treatments fail to target this disease mechanism. Methylnaltrexone (MNTX) has been used to prevent the effects of opioids on the bowel and could reduce the incidence of POI when administered preoperatively. METHODS: In this phase IIb randomized controlled trial, we assessed the effect of perioperative MNTX on time-to-first-bowel movement following spinal arthrodesis surgeries. RESULTS: 82 patients were randomly selected in a 1:1 ratio to be included in either the treatment or placebo groups. Comparison of relevant factors of included patients to patients who refused to participate (n = 21) and to a prior retrospective series (n = 241) revealed no differences in age, male sex, liver disease, and number of surgical levels. Overall treatment fidelity (98% adherence) and retention (100% at one-month follow-up) were high. The predicted POI incidence (9.3-11.1%) was also equivalent to a prior retrospective series. However, the overall observed POI incidence (3.7%) was lower than expected, which could reflect a superimposed 'trial effect' related to standardized care in a research setting. CONCLUSIONS: Since exposure to significant opioid doses represents a barrier to enhanced recovery after surgery, the results of this innovative trial may provide further guidance for the peri-operative use of opioid-receptor blockers. Here, we show that MNTX can be effectively administered in the peri-operative period with appropriate follow-up achieved in a representative population of patients undergoing spinal surgery. TRIAL REGISTRATION NUMBERS: Clinicaltrials.gov - NCT03852524 and Institutional Review Board - 2018H0260.

Perioperative Morbidity and Complications in Patients With an Established Ileostomy Undergoing Major Abdominal Surgery: A Retrospective Study.

Background: Recently formed ileostomies may produce an average of 1,200 ml of watery stool per day, while an established ileostomy output varies between 600-800 ml per day. The reported incidence of renal impartment in patients with ileostomy is 8-20%, which could be caused by dehydration (up to 50%) or high output stoma (up to 40%). There is a lack of evidence if an ileostomy could influence perioperative fluid management and/or surgical outcomes. Methods: Subjects aged ≥18 years old with an established ileostomy scheduled to undergo an elective non-ileostomy-related major abdominal surgery under general anesthesia lasting more than 2 h and requiring hospitalization were included in the study. The primary outcome was to assess the incidence of perioperative complications within 30 days after surgery. Results: A total of 552 potential subjects who underwent non-ileostomy-related abdominal surgery were screened, but only 12 were included in the statistical analysis. In our study cohort, 66.7% of the subjects were men and the median age was 56 years old (interquartile range [IQR] 48-59). The median time from the creation of ileostomy to the qualifying surgery was 17.7 months (IQR: 8.3, 32.6). The most prevalent comorbidities in the study group were psychiatric disorders (58.3%), hypertension (50%), and cardiovascular disease (41.7%). The most predominant surgical approach was open (8 [67%]). The median surgical and anesthesia length was 3.4 h (IQR: 2.5, 5.7) and 4 h (IQR: 3, 6.5), respectively. The median post-anesthesia care unit (PACU) stay was 2 h (IQR:0.9, 3.1), while the median length of hospital stay (LOS) was 5.6 days (IQR: 4.1, 10.6). The overall incidence of postoperative complications was 50% (n = 6). Two subjects (16.7%) had a moderate surgical wound infection, and two subjects (16.7%) experienced a mild surgical wound infection. In addition, one subject (7.6%) developed a major postoperative complication with atrial fibrillation in conjunction with moderate hemorrhage. Conclusions: Our findings suggest that the presence of a well-established ileostomy might not represent a relevant risk factor for significant perioperative complications related to fluid management or hospital readmission. However, the presence of peristomal skin complications could trigger a higher incidence of surgical wound infections.