Results From a Prospective, Clinical Study (US-nPower) Evaluating a Miniature Spinal Cord Stimulator for the Management of Chronic, Intractable Pain.

BACKGROUND: Chronic, intractable, neuropathic pain is readily treatable with spinal cord stimulation (SCS). Technological advancements, including device miniaturization, are advancing the field of neuromodulation. OBJECTIVES: We report here the results of an SCS clinical trial to treat chronic, low back and leg pain, with a micro-implantable pulse generator (micro-IPG). STUDY DESIGN: This was a single-arm, prospective, multicenter, postmarket, observational study. SETTING: Patients were recruited from 15 US-based comprehensive pain centers. METHODS: This open-label clinical trial was designed to evaluate the performance of the Nalu™ Neurostimulation System (Nalu Medical, Inc., Carlsbad, CA) in the treatment of low back and leg pain. Patients, who provided informed consent and were successfully screened for study entry, were implanted with temporary trial leads. Patients went on to receive a permanent implant of the leads and micro-IPG if they demonstrated a >= 50% reduction in pain during the temporary trial period. Patient-reported outcomes (PROs), such as pain scores, functional disability, mood, patient impression of change, comfort, therapy use profile, and device ease of use, were captured. RESULTS: At baseline, the average pain Visual Analog Scale (VAS) score was 72.1 ± 17.9 in the leg and 78.0 ± 15.4 in the low back. At 90 days following permanent implant (end of study), pain scores improved by 76% (VAS 18.5 ± 18.8) in the leg and 75% (VAS 19.7 ± 20.8) in the low back. Eighty-six percent  of both leg pain and low back pain patients demonstrated a >= 50% reduction in pain at 90 days following implant. The comfort of the external wearable (Therapy Disc and Adhesive Clip) was rated 1.16 ± 1.53, on average, at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). All PROs demonstrated statistically significant symptomatic improvement at 90 days following implant of the micro-IPG. LIMITATIONS:   Limitations of this study include the lack of long-term results (beyond 90 days) and a relatively small sample size of 35 patients who were part of the analysis; additionally, there was no control arm or randomization as this was a single-arm study, without a comparator, designed to document the efficacy and safety of the device. Therefore, no direct comparisons to other SCS systems were possible. CONCLUSIONS: This clinical study demonstrated profound leg and low back pain relief in terms of overall pain reduction, as well as the proportion of therapy responders. The study patients reported the wearable aspects of the system to be very comfortable.

Low-Dose Ketamine Infusion for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass: A Prospective Randomized Controlled Trial.

INTRODUCTION: Obesity is a common comorbidity seen in the perioperative setting and is associated with many diseases including cardiovascular disease and obstructive sleep apnea. Laparoscopic Roux-en-Y gastric bypass is the gold standard surgical treatment for patients whose weight is refractory to diet and exercise. Caring for these patients perioperatively presents unique challenges to anesthesiologists and is associated with an increased risk of adverse respiratory events. In our study, we hypothesize that a low-dose perioperative ketamine infusion will reduce opioid consumption and improve analgesia when compared to standard therapy. METHODS: This is a single-center, prospective randomized controlled study enrolling 35 patients in total. Patients were randomized equally into the ketamine and control group. Preop, intraop, and postop management regimens were standardized. The ketamine group received a 0.3 mg/kg ideal body weight ketamine bolus after induction followed by a 0.2 mg/kg/hr ketamine infusion continued into the postop setting for up to 24 hours. Data collected included total perioperative opioids used converted to oral morphine equivalents (ME), pain scores, side effects, hospital length of stay, and patient satisfaction captured via postoperative questionnaires. RESULTS: The use of perioperative opioid consumption was significantly lower in the ketamine group when compared with the control group (179.9 ME versus 248.7 ME, P=0.03). There was no statistically significant difference in pain scores or hospital length of stay postoperatively between the two groups. There were also no reported adverse respiratory events, prolonged sedation, agitation, or other side effects reported in either group. The patient satisfaction questionnaires showed a significant difference with the ketamine group reporting lower maximum pain scores, a decrease in how pain limited activities of daily living once discharged, and increased hospital pain management satisfaction scores. CONCLUSIONS: Perioperative low-dose ketamine infusions significantly reduced opioid consumption in morbidly obese patients undergoing laparoscopic gastric bypass surgery.

Cutaneous mesenchymal tumors treated with Mohs micrographic surgery: a comprehensive review.

Cutaneous mesenchymal tumors (CMT) are rare tumors with wide clinicopathologic heterogeneity. Treatment of malignant cutaneous mesenchymal tumors traditionally includes wide local excision (WLE), though Mohs micrographic surgery (MMS) has been increasingly used. A PubMed literature review of articles from inception until September 2019 related to malignant CMT and surgical treatment with MMS or WLE was completed. Dermatofibrosarcoma protuberans treated with MMS recurred in 1.2% of patients with no reported metastasis. Atypical fibroxanthoma treated with MMS recurred and metastasized in 2.7 and 2.5%, respectively. Undifferentiated pleomorphic sarcoma treated with MMS recurred in 32% with an unknown metastatic rate. Superficial leiomyosarcoma treated with MMS recurred in 3.8% with no reported metastasis. Cutaneous angiosarcoma and myofibrosarcoma treated with MMS have shown no recurrence or metastatic disease, but literature is sparse. The rarity of malignant CMT and the lack of comparative data on treatment make conclusive treatment recommendations difficult. However, recent literature suggests MMS is a useful option and potentially a superior treatment for primary cutaneous mesenchymal tumors.

Liposomal bupivacaine interscalene nerve block in shoulder arthroplasty is not superior to plain bupivacaine: a double-blinded prospective randomized control trial.

BACKGROUND: Interscalene brachial plexus blocks are a common modality used to provide adjunctive pain relief with shoulder replacement surgery. In 2018, the Federal Drug Administration approved the use of liposomal bupivacaine (LB) for such nerve blocks. We sought to evaluate whether this formulation of bupivacaine would provide superior pain relief for shoulder replacement patients over standard bupivacaine alone. Our hypotheses were that in the LB cohort the average postoperative pain score over the first 72 hours would be significantly lower, time to block cessation would be longer, total opioid consumption would be lower, and the average patient satisfaction score regarding their pain management would be higher. MATERIALS AND METHODS: A randomized, double-blinded study was designed comparing primary shoulder replacement surgery after an interscalene block with 25 mL of 0.5% plain bupivacaine vs. 133 mg of LB with 7.5 mL of 0.5% and 7.5 mL of 0.25% plain bupivacaine. A total of 104 patients were included in the study, with an equal number in each study arm. Patients' visual analog pain scores (VAPS) were followed for their inpatient stay, first 3 full outpatient days, and at a 3-week follow-up. Use of opioid medication was recorded for the same intervals and converted to morphine milligram equivalents. The time to first opioid rescue was documented, as well as the patients' satisfaction with their pain management at both the 3-day and 3-week intervals. RESULTS: No clinically relevant advantage to the use of LB over plain bupivacaine was found. During the second postoperative day, the mean VAPS was 2.4 with LB vs. 3.3 in the standard cohort (P = .0409). The only other statistically significant finding was a higher VAPS with LB during the third full day home compared with standard bupivacaine (4.0 vs. 2.8, respectively, P = .0197). Both of these differences were less than the minimal clinically important difference of 2 for the VAPS. Analysis of the VAPS for the first and third postoperative days, the first and second full days home, and at 3 weeks revealed no significant difference. Similarly, there was no significant difference in time to first opioid rescue, total morphine milligram equivalent use, and patient satisfaction with pain management. CONCLUSION: When used for an interscalene block to provide adjunctive pain relief in shoulder replacement surgery, the addition of LB to plain bupivacaine provides no additional clinically important benefit to the patient's pain experience over standard bupivacaine.

Nontraditional Transesophageal Echocardiographic Views to Evaluate Hepatic Vasculature in Orthotopic Liver Transplantation and Liver Resection Surgery.

BACKGROUND: Utilization of intraoperative transesophageal echocardiography (TEE) during orthotopic liver transplantation (OLT) is expanding annually in high-volume transplant centers. During OLT intraoperative TEE is used to gather real-time information on cardiovascular function and intravascular volume status. Although standardized TEE views exist, there are nontraditional views described in the literature which have the potential to diagnose evolving pathology and define normal variants of hepatic vasculature. METHODS: A literature review was completed utilizing the PubMed database for English-only, peer-reviewed publications discussing nontraditional use of intraoperative TEE during OLT and hepatic vascular-related surgeries from 2009 to 2019. Both case reports and review articles were considered. RESULTS: The PubMed literature search offered 8 publications for analysis, including 7 case reports and 1 article review, revealing several nontraditional TEE views not included in a comprehensive transesophageal echocardiographic examination. These nontraditional views were generally obtained using modifications to the transgastric and bicaval views to visualize liver vasculature. We present the various techniques for obtaining these views from the 8 articles identified. CONCLUSIONS: At high-volume transplant centers, TEE use during OLT is increasing. Intraoperative TEE is a valuable tool to assess hepatic vascular structures critical to allograft/organ function without interruption of the surgical procedure. Nontraditional use of TEE to diagnose intraoperative noncardiac pathology in OLT appears underutilized and underreported. The modified hepatic and modified transgastric views we describe can be used to evaluate hepatic vasculature, influence surgical decision-making and ultimately improve patient care.

Tongue Tied after Shoulder Surgery: A Case Series and Literature Review.

This article presents three cases of cranial nerve palsy following shoulder surgery with general anesthesia in the beach chair position. All patients underwent preoperative ultrasound-guided interscalene nerve block. Two cases of postoperative hypoglossal and one case of combined hypoglossal and recurrent laryngeal nerve palsies (Tapia's syndrome) were identified. Through this case series, we provide a literature review identifying postoperative cranial nerve palsies in addition to the discussion of possible etiologies. We suggest that intraoperative patient positioning and/or airway instrumentation is most likely causative. We conclude that the beach chair position is a risk factor for postoperative hypoglossal nerve palsy and Tapia's syndrome.

Ten-year evolution of a massive transfusion protocol in a level 1 trauma centre: have outcomes improved?

BACKGROUND: We aimed to evaluate the evolution and implementation of the massive transfusion protocol (MTP) in an urban level 1 trauma centre. Most data on this topic comes from trauma centres with high exposure to life-threatening haemorrhage. This study examines the effect of the introduction of an MTP in an Australian level 1 trauma centre. METHODS: A retrospective study of prospectively collected data was performed over a 14-year period. Three groups of trauma patients, who received more than 10 units of packed red blood cells (PRBC), were compared: a pre-MTP group (2002-2006), an MTP-I group (2006-2010) and an MTP-II group (2010-2016) when the protocol was updated. Key outcomes were mortality, complications and number of blood products transfused. RESULTS: A total of 168 patients were included: 54 pre-MTP patients were compared to 47 MTP-I and 67 MTP-II patients. In the MTP-II group, fewer units of PRBC and platelets were administered within the first 24 h: 17 versus 14 (P = 0.01) and 12 versus 8 (P < 0.001), respectively. Less infections were noted in the MTP-I group: 51.9% versus 31.9% (P = 0.04). No significant differences were found regarding mortality, ventilator days, intensive care unit and total hospital lengths of stay. CONCLUSION: Introduction of an MTP-II in our level 1 civilian trauma centre significantly reduced the amount of PRBC and platelets used during damage control resuscitation. Introduction of the MTP did not directly impact survival or the incidence of complications. Nevertheless, this study reflects the complexity of real-life medical care in a level 1 civilian trauma centre.

Fatal diffuse pulmonary fat microemboli following reperfusion in liver transplantation with the use of marginal steatotic allografts.

Organ shortage is a major cause of delayed liver transplantation and increased waitlist time. The level of donor steatosis is a significant determinant in organ selection. Scarcity of organs has led some programs to expand their acceptable criteria for the percentage of steatosis. We report two cases of liver transplantation of steatotic donor organs that resulted in mortality within hours from transplantation. Postmortem analysis showed evidence of diffuse pulmonary fat microemboli likely originating from the donor organ, with marked preservation reperfusion injury. The mechanism of diffuse fat microemboli in this setting and possible relationship to other perioperative syndromes (transfusion-related lung injury, acute kidney injury, and postreperfusion syndrome) is discussed.

Chronic immunosuppression in the mature patient.

In the ever-aging population of the world, the field of geriatrics continues to grow in importance. As human beings age, the skin undergoes a unique array of changes that predispose it to a specific set of dermatoses, infections, and neoplasms. Some of these physiologic alterations are comparable to the changes that happen in immunosuppressed individuals. Given the importance of immunosuppressive medications in treatment of many common skin conditions, we have reviewed the current literature to assist the practicing clinician in using immunosuppressive medications in the geriatric population.

The effect of ampule size of fentanyl on perioperative intravenous opioid dosing.

BACKGROUND AND AIMS: There are limited data on the effect of ampule size on drug dosing. The objective of this study is to determine the effect of ampule size on perioperative opioid dosing and post-anesthesia care unit (PACU) outcomes. MATERIAL AND METHODS: This was a retrospective review of patients undergoing robotically assisted laparoscopic radical prostatectomy before and after a 5-ml fentanyl ampule was discontinued. The primary outcome was intraoperative opioid administration divided into fentanyl at induction of anesthesia, total fentanyl, and total opioid. Secondary outcomes observed in PACU included the opioid administered, visual analog scale (VAS) pain scores, postoperative nausea and vomiting, and length of stay in PACU. RESULTS: A total of 100 patients (50 PRE and 50 POST) were included. In the intraoperative opioid administration, mean (SD) of fentanyl at induction was 117.0 (49.3) in PRE group and 85.0 (35.4) µg in POST group (P < 0.01). The total fentanyl requirement was 247.0 (31.0) in PRE group and 158.5 (85.1) µg in POST group (P < 0.01). The total opioid in intravenous morphine equivalents (IVME) was 34.1 (5.8) in PRE group and 23.2 (6.8) mg in POST group (P < 0.01). Among the secondary outcomes, mean (SD) of IVME of opioid was 7.7 (8.2) in PRE group and 9.9 (8.1) mg in POST group (P = 0.18). The VAS pain score on arrival was 0.7 (1.4) in PRE group and 3.8 (3.3) in POST group (P < 0.01). The cumulative VAS pain score was 2.3 (2.0) in PRE group and 3.3 (2.2) in POST group (P < 0.01). The length of stay was significantly more in POST group, 193.8 (75.8) minutes, as compared with PRE group, 138.6 (61.0) minutes (P < 0.01). CONCLUSIONS: A change in the ampule size significantly affected intraoperative dosing, PACU pain scores, and PACU length of stay in patients undergoing robotically assisted laparoscopic radical prostatectomy under general anesthesia. This was explained by clinician's desire to conserve the drug and avoid the complex process of narcotic waste disposal.

Survey of pain specialists regarding conversion of high-dose intravenous to neuraxial opioids.

The conversion of high-dose intravenous (IV) opioids to an equianalgesic epidural (EP) or intrathecal (IT) dose is a common clinical dilemma for which there is little evidence to guide practice. Expert opinion varies, though a 100 IV:10:EP:1 IT conversion ratio is commonly cited in the literature, especially for morphine. In this study, the authors surveyed 724 pain specialists to elucidate the ratios that respondents apply to convert high-dose IV morphine, hydromorphone, and fentanyl to both EP and IT routes. Eighty-three respondents completed the survey. Conversion ratios were calculated and entered into graphical scatter plots. The data suggest that there is wide variation in how pain specialists convert high-dose IV opioids to EP and IT routes. The 100 IV:10 EP:1 IT ratio was the most common answer of survey respondent, especially for morphine, though also for hydromorphone and fentanyl. Furthermore, more respondents applied a more aggressive conversion strategy for hydromorphone and fentanyl, likely reflecting less spinal selectivity of those opioids compared with morphine. The authors conclude that there is little consensus on this issue and suggest that in the absence of better data, a conservative approach to opioid conversion between IV and neuraxial routes is warranted.

Randomized trial of epidural vs. subcutaneous catheters for managing pain after modified Nuss in adults.

BACKGROUND: Minimally invasive repair of pectus excavatum (MIRPE) is now performed in adults. Managing adult patients' pain postoperatively has been challenging due to increased chest wall rigidity and the pressure required for supporting the elevated sternum. The optimal pain management regimen has not been determined. We designed this prospective, randomized trial to compare postoperative pain management and outcomes between thoracic epidural analgesia (TEA) and bilateral subcutaneous infusion pump catheters (On-Q). METHODS: Patients undergoing MIRPE (modified Nuss) underwent random assignment to TEA or On-Q group. Both groups received intravenous, patient-controlled opioid analgesia, with concomitant delivery of local anesthetic. Primary outcomes were length of stay (LOS), opioid use, and pain scores. RESULTS: Of 85 randomly assigned patients, 68 completed the study [52 men, 76.5%; mean (range) age, 32.2 (20.0-58.0) years; Haller index, 5.9 (range, 3.0-26.7)]. The groups were equally matched for preoperative variables; however, the On-Q arm had more patients (60.3%). No significant differences were found between groups in mean daily pain scores (P=0.52), morphine-equivalent opioid usage (P=0.28), or hospital stay 3.5 vs. 3.3 days (TEA vs. On-Q; P=0.55). Thirteen patients randomized to TEA refused the epidural and withdrew from the study because they perceived greater benefit of the On-Q system. CONCLUSIONS: Postoperative pain management in adults after MIRPE can be difficult. Both continuous local anesthetic delivery by TEA and On-Q catheters with concomitant, intravenous, patient-controlled anesthesia maintained acceptable analgesia with a reasonable LOS. In our cohort, there was preference for the On-Q system for pain management.

Findings of a Naloxone Database and its Utilization to Improve Safety and Education in a Tertiary Care Medical Center.

INTRODUCTION: Analyzing hospital naloxone use may assist in identification of areas for quality and safety improvement. Our primary objective is to quantitate the incidence of hospital naloxone use and to assess certain patient populations at risk. METHODS: During the years 2008 to 2011, each clinical scenario where naloxone was administered on an in-patient care ward was reviewed. The events were assessed to separate situations where naloxone rescue was effective in reversing opioid-induced intoxication vs. others. Further analysis was conducted to stratify patient populations at greatest risk. RESULTS: Naloxone was administered for well-defined opioid-induced respiratory depression and oversedation 61% of the time, the remainder used for patient deterioration of other etiology. Surgical populations are at risk with an incidence of 3.8/1,000 hospitalized patients, and this is the greatest within 24 hours of surgery. General surgical patients represent the highest surgical patient risk at 5.5/1,000. Medical patients represent lower risk at 2.0/1,000. Patients with patient-controlled analgesia and epidural opioid infusion are high risk at 12.1 and 13.1/1,000 patients, respectively. Many quality and safety interventions were gradually implemented in response to this data and are summarized. These include nursing and provider education, electronic medical record modification, and more stringent patient monitoring practices. CONCLUSION: Examination of naloxone use can assist in the identification and stratification of patients at risk for opioid-induced respiratory depression and oversedation and can serve as a driver for improvements in hospital patient safety. This information can also guide other institutions interested in similar improvements.

Combined accurate platelet enumeration and reticulated platelet determination by flow cytometry.

BACKGROUND: Diagnosing the cause of thrombocytopenia often requires a bone marrow aspiration or biopsy, an invasive procedure. Reticulated platelets (RP) are immature RNA containing platelets, accurate RP enumeration has yet to be achieved, partially due to the lack of a robust reference method. GOAL: To refine previous work and gating strategies distinguishing RP from mature platelets while incorporating accurate platelet enumeration into the analysis. After reviewing previously published studies on Thiazole Orange (TO) staining of RP, we systematically evaluated CD41/CD61 in combination with a commercial source of TO (BDBiosciences). Previous RP methods have not taken advantage of platelet enumeration therefore our goal was to incorporate the ICSH platelet enumeration protocol into our method. METHODS: TO concentration, incubation, and fixation method were determined to be 10% of stock concentration, 30 min, and 1% formaldehyde respectively. Gating strategy to determine RP fraction used an unstained control tube to set the limit of TO staining. RESULTS: Normal range (n = 51) was 9.9 ± 3.1%. Analysis of 40 patients with immune-thrombocytopenia-purpura (ITP) showed a RP range from 4.3% to 81.2%. Platelet enumeration was consistent with our previous studies in this area. CONCLUSIONS: Combining CD41/CD61 platelet enumeration with TO RP percentage is possible. Accurate RP percentage requires an effective gating strategy, as background fluorescence cursor placement is important. This method for enumeration of RP percentage combined with accurate platelet enumeration, particularly in the low range, should prove useful in differentiating production from consumption issues in thrombocytopenia and monitoring response to therapy.

Patient understanding of the importance of statin use in the perioperative period.

OBJECTIVE: Perioperative hydroxy-3-methyl glutaryl coenzyme A reductase inhibitors (statins) have been shown to decrease morbidity and mortality after noncardiac surgery. The objective of this study was to assess patient understanding of the potential benefits of perioperative statins in a select population already on chronic therapy. A secondary aim was to determine the frequency with which patients recalled having a discussion with their provider regarding perioperative statins. DESIGN: Survey. SETTING: Teaching hospital. PARTICIPANTS: Patients taking daily statins presenting to a preoperative medical evaluation clinic were offered a 12-question survey that assessed their understanding of the potential benefit of taking the medication in the perioperative period. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: One hundred thirty-two patients completed the questionnaire. The mean age was 68.3 years (standard deviation, 9.0); 42% were female. The most frequent surgical referral to the clinic was orthopedics, at 36%. The most common statin prescribed was atorvastatin, in 35% of patients. Twenty-seven percent of patients (n = 36) recognized that perioperative statins are beneficial; 44% of these patients (n = 14) cited decreased cholesterol during the procedure as the reason, representing 12% of the total sampled population. Twenty-two percent (n = 8) of those recognizing the benefit of perioperative statins identified a decrease in the risk of heart attack or death as the reason. This represented only 6% of the total sample. One percent of surgeons mentioned statins in relation to the planned surgery; 2% of primary or prescribing physicians mentioned the medication in relation to surgery. CONCLUSIONS: This study suggested low patient understanding of the potential importance and reasons for perioperative statins. In addition, this study also suggested that the information regarding the importance of perioperative statins is not being relayed to the patient at the level of the surgeon or primary care physician. All physicians involved in perioperative care can offer improved patient education to promote compliance with statin therapy in hopes of a favorable impact on perioperative outcomes.

Treatment of microperforate hymen with serial dilation: a novel approach.

BACKGROUND: Microperforate and imperforate hymens are one of the most common causes of vaginal outflow obstruction in the adolescent population. To date, these hymen anomalies are traditionally treated by hymenectomy with a cruciate excision. CASES(S): We report 2 cases of adolescent women with a microperforate hymen who were successfully and minimally invasively treated with progressive dilation with Hegar cervical dilators until a number 23 dilator was reached under anesthesia in the OR. SUMMARY AND CONCLUSION: Minimally invasive treatment of microperforate hymen with the use of progressive cervical dilators may be an alternative technique to the traditional excisional hymenectomy. Our patients reported satisfaction and minimal postoperative pain or scarring at 2 weeks and 6 months after the procedure. This technique can be an additional option for all women, especially those with cultural beliefs in virginity.