Birth outcomes and usability of Relaxbirth® for upright positioning intrapartum: A retrospective case control study.

INTRODUCTION: The aim of this study was to pilot Relaxbirth® (Relaxbirth®, Ltd., Helsinki, Finland), an investigational device designed to facilitate upright positioning intrapartum. The objective was to 1) compare birth outcomes with and without the use of Relaxbirth®, and 2) assess device usability. METHODS AND MATERIALS: Study design: prospective product use and retrospective case control study at one perinatal center in Ohio. INCLUSION CRITERIA: ≥18 years old, <300 lbs. women with a low-risk, term gestation of a singleton, vertex fetus, and vaginal birth between January 2013 to June 2016. Participants who used the Relaxbirth® device intrapartum (RB group) were retrospectively case-matched to controls (CON group) according to age, race, insurance, gravida/parity, gestational age and labor type. Birth outcomes (primary outcome) were compared between groups. Providers and women who used Relaxbirth® assessed usability of the device with the Modified System Usability Scale Tool (secondary outcome). RESULTS: Of the n = 60 included in the final analysis, RB women (n = 30) pushed for a shorter average duration compared to CON women (n = 30) [34 min (±48) versus 60 min (±63), p = 0.023]. RB women did not experience more adverse birth outcomes including: longer second stage duration, operative vaginal delivery, malpresentation, perineal laceration/episiotomy, higher blood loss, or low Apgars. Usability survey results were favorable (Total Average Scores: providers 74.1; RB 83.6). CONCLUSION: Clinical experience with the Relaxbirth® device was positive at this pilot site. The device was associated with favorable birth outcomes and usability, suggesting potential as a safe and novel adjunct to promote intrapartum choices, upright positioning and maternal satisfaction.

Obesity-related endometrial cancer: an update on survivorship approaches to reducing cardiovascular death.

As the rate of obesity increases worldwide, so will the number of women diagnosed with obesity-related malignancy. The strongest correlation between obesity and cancer is endometrial cancer (EC). Obesity is the most significant modifiable risk factor for development of EC and also contributes to the most common cause of death in EC survivors-cardiovascular disease (CVD). Most cancer survivors after diagnosis do not implement lifestyle changes aimed at weight-loss and CVD risk reduction. This selective review highlights recent novel and unique approaches for managing CVD co-morbidities in EC survivorship.

Direct Screening of Blood by PCR and Pyrosequencing for a 16S rRNA Gene Target from Emergency Department and Intensive Care Unit Patients Being Evaluated for Bloodstream Infection.

Here we compared the results of PCR/pyrosequencing to those of culture for detecting bacteria directly from blood. DNA was extracted from 1,130 blood samples from 913 patients suspected of bacteremia (enrollment criteria were physician-ordered blood culture and complete blood count [CBC]), and 102 controls (healthy blood donors). Real-time PCR assays for beta-globin and Universal 16S rRNA gene targets were performed on all 1,232 extracts. Specimens identified by Universal 16S rRNA gene PCR/pyrosequencing as containing staphylococci, streptococci, or enteric Gram-negative rods had target-specific PCR/pyrosequencing performed. Amplifiable beta-globin (melting temperature [Tm], 87.2°C ± 0.2°C) occurred in 99.1% (1,120/1,130) of patient extracts and 100% (102/102) of controls. Concordance between PCR/pyrosequencing and culture was 96.9% (1,085/1,120) for Universal 16S rRNA gene targets, with positivity rates of 9.4% (105/1,120) and 11.3% (126/1,120), respectively. Bacteria cultured included staphylococci (59/126, 46.8%), Gram-negative rods (34/126, 27%), streptococci (32/126, 25.4%), and a Gram-positive rod (1/126, 0.8%). All controls screened negative by PCR/pyrosequencing. Clinical performance characteristics (95% confidence interval [CI]) for Universal 16S rRNA gene PCR/pyrosequencing included sensitivity of 77.8% (69.5 to 84.7), specificity of 99.3% (98.6 to 99.7), positive predictive value (PPV) of 93.3% (86.8 to 97.3), and negative predictive value (NPV) of 97.2% (96.0 to 98.2). Bacteria were accurately identified in 77.8% (98/126) of culture-confirmed sepsis samples with Universal 16S PCR/pyrosequencing and in 76.4% (96/126) with follow-up target-specific PCR/pyrosequencing. The initial PCR/pyrosequencing took ∼5.5 h to complete or ∼7.5 h when including target-specific PCR/pyrosequencing compared to 27.9 ± 13.6 h for Gram stain or 81.6 ± 24.0 h for phenotypic identification. In summary, this molecular approach detected the causative bacteria in over three-quarters of all culture-confirmed cases of bacteremia directly from blood in significantly less time than standard culture but cannot be used to rule out infection.

Self-efficacy, quality of life, and weight loss in overweight/obese endometrial cancer survivors (SUCCEED): a randomized controlled trial.

OBJECTIVE: More patient-centered programming is essential for endometrial cancer (EC) survivors needing to lose weight to reduce cardiovascular disease risk (CVD). The purpose of this study was to improve self-efficacy (SE) and quality of life (QOL) using a lifestyle intervention program designed for weight loss. METHODS: Overweight and obese early-stage EC survivors, n = 75, were randomized into two groups: 1) Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED), a six-month lifestyle intervention or 2) a usual care group (UC). Participants completed the Weight Efficacy Lifestyle Questionnaire (WEL) to assess SE and the Functional Assessment of Cancer Therapy-General (FACT-G) to measure QOL, and their body mass index (BMI) was calculated at baseline, 3, 6, and 12 months. Mixed, repeated-measures ANCOVA models with baseline covariates were employed using SPSS 20.0. RESULTS: Positive effects in every WEL domain, including the total score, were statistically significant in the SUCCEED group versus the UC group. A linear regression model demonstrated that, if BMI decreased by 1 unit, the total WEL score increased by 4.49 points. Significant negative correlations were found in the total WEL score and a change in BMI of R = -0.356 (p = 0.006). Between-group differences in the FACT-G were significant from baseline in the fatigue domain at three months (p = .008) and in the physical domain at six months (p = .048). No other significant differences were found. CONCLUSION: Overall, this study shows promise for targeted interventions to help improve SE, thus improving BMI.

Latent profile analysis of pelvic floor muscle pain in patients with chronic pelvic pain.

AIM: Chronic pelvic pain (CPP) is a syndrome of related diagnoses including pain originating from the muscles of the pelvic floor. The objective of this study was to evaluate which muscles are important to examine, in what manner pelvic floor muscle pain contributes to patients' pain experience, or what thresholds should be applied to identify significant pelvic floor muscle pain by comparing exam findings with outcome measures METHODS: A total of 428 patients meeting the definition for CPP were evaluated using a standardized physical examination of the abdominal wall, pelvic floor, and vestibule along with the 12 domain Patient Reported Outcome Measures Information System (PROMIS). These scores were evaluated for unidimensionality followed by latent profile analysis. The areas under the receiver operator characteristic curves were used to identify the best pain threshold for each muscle. RESULTS: The eight pelvic floor muscle sites all loaded onto a single factor, separate from other areas examined. Two latent classes were found within all the variables. Patients in the severe pelvic floor pain class had significantly worse pain related PROMIS scores. Optimal thresholds for identifying significant pelvic floor pain ranged between 3 and 5. CONCLUSION: Pain in the pelvic floor muscles is distinguishable from pain in the abdominal wall and vulva. Any of the lateral muscle sites evaluated can be used to identify patients with significant pelvic floor pain. Two latent classes of CPP patients were identified: those with limited and those with severe pain, as identified by moderate to severe pelvic floor tenderness.

Phenotyping chronic pelvic pain based on latent class modeling of physical examination.

Introduction. Defining clinical phenotypes based on physical examination is required for clarifying heterogeneous disorders such as chronic pelvic pain (CPP). The objective of this study was to determine the number of classes within 4 examinable regions and then establish threshold and optimal exam criteria for the classes discovered. Methods. A total of 476 patients meeting the criteria for CPP were examined using pain pressure threshold (PPT) algometry and standardized numeric scale (NRS) pain ratings at 30 distinct sites over 4 pelvic regions. Exploratory factor analysis, latent profile analysis, and ROC curves were then used to identify classes, optimal examination points, and threshold scores. Results. Latent profile analysis produced two classes for each region: high and low pain groups. The optimal examination sites (and high pain minimum thresholds) were for the abdominal wall region: the pair at the midabdomen (PPT threshold depression of > 2); vulvar vestibule region: 10:00 position (NRS > 2); pelvic floor region: puborectalis (combined NRS > 6); vaginal apex region: uterosacral ligaments (combined NRS > 8). Conclusion. Physical examination scores of patients with CPP are best categorized into two classes: high pain and low pain. Standardization of the physical examination in CPP provides both researchers and general gynecologists with a validated technique.

Analgesic efficacy of parenteral paracetamol (propacetamol) and diclofenac in post-operative orthopaedic pain.

BACKGROUND: Propacetamol is an injectable pro-drug of paracetamol (acetaminophen) with analgesic and antipyretic activities, especially used in the post-operative period. The aim of this study was to assess the analgesic efficacy and safety of intravenous paracetamol, administered as propacetamol, in comparison with placebo and intramuscular diclofenac in patients with post-operative pain. METHODS: This was a randomized, double-blind, double-dummy study. One hundred and twenty patients with moderate to severe pain following total hip arthroplasty received either two administrations of propacetamol 2 g intravenously, 5 h apart (n = 40), one single administration of diclofenac 75 mg intramuscularly (n = 40) or placebo (n = 40). Efficacy measures were assessed before each drug administration, for the 5 h following each study treatment administration and for the total study duration of 10 h. Safety was assessed by reporting adverse events and changes in vital signs, electrocardiogram (ECG) and biochemical investigations before and 24 h after dosing. RESULTS: Both active treatments were effective and statistically superior to placebo over the whole study period, as indicated by the total pain relief score. No significant differences were found between propacetamol and diclofenac for any measures of analgesic activity. Only minor and common adverse events were reported, with no overall differences between the groups. CONCLUSION: Both active treatments were superior to placebo, and the overall efficacy of two intravenous infusions of propacetamol 2 g (equivalent to 1 g of paracetamol), 5 h apart, was not statistically different from that provided by a single intramuscular injection of diclofenac 75 mg over the first 5 h post-dose and over the total 10-h study period. The safety was good.

Separation of the insecticidal pyrethrin esters by capillary electrochromatography.

A simple, rapid technique for the direct separation and quantification of the six insecticidally active pyrethrin esters in typical extracts and commercial formulations by capillary electrochromatography (CEC) has been described. The separation of the pyrethrin esters was achieved by optimizing several parameters including the length of stationary phase, the mobile phase composition and column temperature. The mobile phase composition had the most pronounced effect toward resolving these structurally similar compounds. A ternary mobile phase composed of acetonitrile-aqueous buffer-tetrahydrofuran (55:35:10) provided the elutropic solvent strength needed to resolve the six esters from an extract mixture in under 16 min. A 25 cm packed bed of Hypersil 3 microm C18 stationary phase was used with the ternary mobile phase at 25 degrees C and 30 kV voltage. These conditions also yielded excellent separation of the pyrethrin esters in two different commercially available insecticidal formulations. In addition, the developed CEC method was shown to be a fast and easy way of quantifying the amount of these esters in typical pyrethrin formulations.

Capillary electrophoretic separation of binaphthyl enantiomers with two polymeric chiral surfactants: 1H-nuclear magnetic resonance and fluorescence spectroscopy study.

The use of the water-soluble polymeric chiral surfactants (PCS), sodium N-undecanoyl-L-valinate (poly-L-SUV) and sodium undecanoyl-L-isoleucinate (poly-L-SUI) as buffer additives in electrokinetic chromatography (EKC) afforded the separation of racemic mixtures of 2,2'-dihydroxy-1,1'-binaphthyl (BOH) and 1,1'-binaphthyl-2,2'-diyl hydrogen phosphate (BNP). The apparent binding constants of the PCS to the enantiomers of BNP and BOH were obtained through 1H-nuclear magnetic resonance (1H-NMR) titrations and fluorescence spectroscopy, respectively. The 1H-NMR titration studies show that the BNP enantiomers are localized in the hydrophobic micellar pockets of PCS and form complexes of a 1:1 stoichiometry. The binding constants of PCS of BOH were determined from a Benesi-Hildebrand treatment of the fluorescence data. The EKC data corroborate those of the binding constants, supporting the formation of inclusion complexes. A model rationalizing the chiral discrimination of the enantiomers of BNP is proposed based on the intermolecular interactions observed in 1H-NMR data.

A comparison of regularly administered sustained release oral morphine with intramuscular morphine for control of postoperative pain.

UNLABELLED: We studied the efficacy and side effect profile of regularly administered, oral sustained-release morphine sulfate tablets (MST) and IM morphine in patients undergoing total hip arthroplasty under lumbar spinal anesthesia. Patients in Group I received MST 20 mg 12 hourly and a placebo IM injection 6 hourly regularly. Group II patients received an oral placebo 12 hourly and morphine sulfate 10 mg IM 6 hourly regularly. Rescue analgesia was provided with regular diclofenac suppositories and patient-controlled analgesia. Pain scores assessed by using visual analog scale and verbal pain scoring at rest and with movement were low in both groups, with no statistical difference between groups. Mean patient-controlled analgesia morphine consumption during the 48-h study was 16.7 mg in the IM group and 25.9 mg in the MST group. The difference between the groups was significant at 36 h postoperatively (0.03). Side effects of sedation and respiratory depression were not problematic in either group, with a maximal sedation score of 2 occurring once in a patient in Group II. Nausea and vomiting occurred more often in Group II, but this was not statistically significant, with a mean nausea/vomiting score for Group II of 1.7. We conclude that oral, sustained-release morphine is an attractive alternative to IM opiates in patients undergoing body surface surgery under regional anesthesia. IMPLICATIONS: Each postoperative analgesic has its own limitations for route of administration, dosage, and potential side effects. Using the oral route for drug administration seems more attractive than other methods but may not be suitable in all postoperative patients. We studied the efficacy and side effect profile of sustained-release, oral morphine compared with standard IM morphine for the treatment of pain after hip replacement surgery. We concluded that use of the oral preparation is a suitable alternative to the IM route in this population undergoing surgery under spinal anesthesia.

Intra-articular tenoxicam improves postoperative analgesia in knee arthroscopy.

PURPOSE: Non Steroidal Anti-inflammatory drugs have a well documented benefit in the relief of postoperative pain. This study was designed to compare the analgesic effect of intra-articular tenoxicam 20 mg with intravenous tenoxicam on postoperative pain in 88 patients undergoing day case knee arthroscopy. METHODS: A prospective, double blind, randomized trial was performed. All patients received a standard general anesthetic. Patients in group A received 20 mg tenoxicam made up to 40 ml with normal saline intra-articularly (ia) and 2 ml normal saline i.v. Patients in group B received 40 ml normal saline intra-articularly and 2 ml, 20 mg of tenoxicam, i.v. RESULTS: Both groups of patients were similar with respect to age, weight, sex and tourniquet inflation time. Patients receiving ia tenoxicam had lower pain scores (at rest and upon movement) at 30, 60, 120 and 180 min postoperatively (0.8+/-0.2 vs. 2.5+/-0.2 at rest and 1.24+/-0.2 vs. 3.4+/-0.2 at movement at 60 min; P< 0.0001). Fewer patients required additional analgesia in the first four hours postoperatively (33% vs. 84%; P<0.00001) and the time to first analgesia (23.7+/-11.2 vs. 9.4+/-0.6; P<0.02) was longer in those receiving ia tenoxicam. CONCLUSION: Intra-articular tenoxicam provides superior postoperative analgesia and reduces postoperative analgesic requirements compared with i.v. tenoxicam in patients undergoing day case knee arthroscopy.

Simple and rapid visual sensing of saccharides.

Solutions of compound 1 exhibit dramatic, characteristic color changes in response to sugar analytes. Structurally related saccharides including glucose phosphates and amino and carboxylic acid sugars can be readily distinguished by visual inspection. These findings should promote the design of unique color sensory materials based on readily available, functional macrocyclic hosts.

Clonidine at induction reduces shivering after general anaesthesia.

PURPOSE: Postanaesthetic shivering occurs in 5-65% of patients. In addition to causing discomfort, it is associated with deleterious consequences. Our objective was to investigate the effect of 150 micrograms clonidine, at induction of anaesthesia, on perioperative core and peripheral temperature, incidence of postanaesthetic shivering and patients' perception of cold. METHODS: Sixty ASA 1 or 2 patients scheduled for elective orthopaedic limb surgery were randomly allocated to group 1, who received 150 micrograms clonidine iv, or group 2, who received a saline bolus iv, before induction. In all patients, anaesthesia was induced with fentanyl and propofol and maintained by spontaneous respiration (via a laryngeal mask airway) of oxygen, nitrous oxide and enflurane. Core (nasopharyngeal) and peripheral (dorsal hand) temperatures were recorded at induction and 15-min intervals. Nurses, unaware of the treatment groups, recorded visible shivering in the recovery room. When cognitive function returned, patients were asked to grade their perception of cold on a 10 cm linear analogue scale, higher scores indicating heat discomfort. RESULTS: While core temperature decreased and peripheral temperature increased in both groups, there was no difference between the groups at any time. However, there was a lower incidence of shivering in the clonidine group (20% vs 66.7%, P < 0.001). Patients receiving clonidine felt warmer; thermal comfort score (median interquartile range) 5.9 (5.0-7.2) vs 5.0 (4.5-6.0), P < 0.05). CONCLUSION: Clonidine 150 g iv at induction of anaesthesia reduces the incidence of shivering and patients' subjective perception of cold on emergence from general anaesthesia.

Role of quality assessment in improving red blood cell transfusion practice.

A prospective analysis of perioperative red blood cell transfusion practice in 110 patients undergoing elective primary total hip arthroplasty was conducted as a part of a quality assessment programme at the National Orthopaedic Hospital. In addition to demographic and clinical data, blood loss and perioperative transfusions were also recorded. Blood was collected for evaluation of haematocrit levels at predetermined intervals (preoperative and 6 h, 1, 2, 3, 7 days, postoperatively). Blood transfused with the patient's haematocrit of more than 30 per cent was considered inappropriate. In addition, a discharge haematocrit exceeding 36 per cent was chosen to identify overtransfusion. Eighty-four per cent were transfused a total of 191 units of homologous blood. Only 4 units were transfused between 3 patients, intraoperatively. All intraoperative transfusions were appropriate. Using the preset criteria (i.e. blood transfused with haematocrit of more than 30 per cent), 36 per cent of total units transfused were inappropriate. Using the criterion of discharge haematocrit of more than 36 per cent, 24 per cent of the patients were overtransfused. As compared to a previous retrospective analysis of blood transfusion in the same patient population which showed that inappropriate transfusion occurred in 45 per cent of the patients, the results from this study suggest a trend towards a more conservative transfusion practice. The improvement in transfusion practice may be due to the ongoing quality assurance programme and the use of transfusion guidelines.

Prevention of spinal anesthesia-induced hypotension in the elderly: comparison between preanesthetic administration of crystalloids, colloids, and no prehydration.

The practice of routinely prehydrating patients by infusing a crystalloid or colloid solution (up to 1.0 L/70 kg) for prevention of spinal anesthesia-induced hypotension has been challenged recently, after several reports of failure to demonstrate its efficacy in young women. We compared the incidence and frequency of hypotension and vasopressor therapy after spinal anesthesia and no prehydration with crystalloid and colloid prehydration in elderly patients. Eighty-five ASA grade I or II patients (aged 60-89 yr) for elective total hip replacement were randomized to receive 500 mL crystalloid solution (Hartmanns, n = 29), 500 mL colloid (Haemaccel, n = 28), or no prehydration (n = 28) over 10 min prior to spinal anesthesia. Hypotension was defined as a 30% decrease from baseline systolic blood pressure (BP) or systolic < 90 mm Hg, and was treated with ephedrine 3-mg boluses. Although absolute systolic BP readings were significantly higher in the colloid group between 6 and 30 min (P < 0.05), the incidence of hypotension was not significantly different between the groups. The incidence of ephedrine use, incidence of nausea/vomiting, and median total dose of ephedrine were similar in all groups. We conclude that, in elderly patients undergoing elective procedures, withholding prehydration is not associated with any greater degree of hypotension or need for vasopressor therapy compared with crystalloid or colloid prehydration.

The efficacy of single-dose aprotinin 2 million KIU in reducing blood loss and its impact on the incidence of deep venous thrombosis in patients undergoing total hip replacement surgery.

STUDY OBJECTIVE: To evaluate the efficacy of a 2 million KIU single dose of aprotinin on blood loss, transfusion requirements, and incidence of deep venous thrombosis (DVT) in patients undergoing total hip replacement surgery. DESIGN: Randomized study. SETTING: Operating theater at an orthopedic hospital. PATIENTS: 40 adult patients scheduled for total hip replacement surgery. INTERVENTIONS: Patients were randomized to two groups. Group A (n = 20) received 2 million KIU of aprotinin over 20 minutes, Group C (n = 20), the control group, received placebo. Anesthesia and surgical technique were standardized. MEASUREMENTS AND MAIN-RESULTS: Intraoperative blood loss, postoperative blood loss, transfusion requirements (48 hr), hemoglobin, coagulation parameters, and platelet counts were assessed. On the seventh postoperative day, all patients in both groups underwent venography to ascertain the incidence of DVT. We found no significant difference in blood loss or transfusion requirements between the two groups. Intraoperative and postoperative blood losses, coagulation parameters, and incidence of DVT did not differ significantly between the two groups. CONCLUSION: A single 2 million KIU bolus dose of aprotinin does not reduce perioperative blood loss or transfusion requirements. Aprotinin therapy, when used in conjunction with other antithrombotic therapies, does not increase the incidence of DVT after major orthopedic surgery.

Modification of pain on injection of propofol. A comparison of pethidine and lignocaine.

One hundred and fifty ASA 1 and 2 patients were randomly allocated to receive pethidine 25 mg (1 ml), lignocaine 10 mg (1 ml) or 0.9% saline (1 ml) on a double-blind basis, as pretreatment to reduce pain on injection of propofol. Both active treatments were significantly better than placebo at preventing pain (p < 0.01). Lignocaine was most effective in preventing pain in men (p < 0.05) whilst pethidine was more effective in women (p < 0.05).

Intrathecal morphine: one year's experience in cardiac surgical patients.

OBJECTIVES: This study was designed to assess the benefits and complications associated with the use of intrathecal morphine (ITM) in patients undergoing coronary artery bypass surgery (CABG). DESIGN: This was a retrospective chart review. SETTING: The study was performed in a single hospital that is affiliated with a university medical school. PARTICIPANTS: The charts of all patients who presented for CABG in a 12-month period were reviewed. INTERVENTIONS: All patients entered into the study had received ITM (0.03 mg/kg) at induction of anesthesia. MEASUREMENTS AND MAIN RESULTS: Complete data were available for 152 patients (86%). Median duration of ventilation postoperatively was 12 hours, and median duration of stay in the ICU was 72 hours. All patients received additional postoperative opioid analgesia, many by the epidural route. Fifteen percent developed respiratory complications, and the incidence of respiratory depression was 1.9%. Thirty-five percent required inotropic support; 17% percent were treated for hypertension; and 49% received antiarrhythmic therapy. The re-infarction rate was 2.6%, and 3% developed cardiac tamponade. Three patients developed neurologic complications unrelated to lumbar puncture. There were no in-hospital deaths. CONCLUSIONS: ITM is safe and provides effective pain relief after cardiac surgery. The high incidence of respiratory depression confirms the need for close observation of these patients postoperatively.