Challenges With Continuous Pulse Oximetry Monitoring and Wireless Clinician Notification Systems After Surgery: Reactive Analysis of a Randomized Controlled Trial.

BACKGROUND: Research has shown that introducing electronic Health (eHealth) patient monitoring interventions can improve healthcare efficiency and clinical outcomes. The VIGILANCE (VItal siGns monItoring with continuous puLse oximetry And wireless cliNiCian notification aftEr surgery) study was a randomized controlled trial (n=2049) designed to assess the impact of continuous vital sign monitoring with alerts sent to nursing staff when respiratory resuscitations with naloxone, code blues, and intensive care unit transfers occurred in a cohort of postsurgical patients in a ward setting. This report identifies and evaluates key issues and challenges associated with introducing wireless monitoring systems into complex hospital infrastructure during the VIGILANCE eHealth intervention implementation. Potential solutions and suggestions for future implementation research are presented. OBJECTIVE: The goals of this study were to: (1) identify issues related to the deployment of the eHealth intervention system of the VIGILANCE study; and (2) evaluate the influence of these issues on intervention adoption. METHODS: During the VIGILANCE study, issues affecting the implementation of the eHealth intervention were documented on case report forms, alarm event forms, and a nursing user feedback questionnaire. These data were collated by the research and nursing personnel and submitted to the research coordinator. In this evaluation report, the clinical adoption framework was used as a guide to organize the identified issues and evaluate their impact. RESULTS: Using the clinical adoption framework, we identified issues within the framework dimensions of people, organization, and implementation at the meso level, as well as standards and funding issues at the macro level. Key issues included: nursing workflow changes with blank alarm forms (24/1030, 2.33%) and missing alarm forms (236/1030, 22.91%), patient withdrawal (110/1030, 10.68%), wireless network connectivity, false alarms (318/1030, 30.87%), monitor malfunction (36/1030, 3.49%), probe issues (16/1030, 1.55%), and wireless network standards. At the micro level, these issues affected the quality of the service in terms of support provided, the quality of the information yielded by the monitors, and the functionality, reliability, and performance of the monitoring system. As a result, these issues impacted access through the decreased ability of nurses to make complete use of the monitors, impacted care quality of the trial intervention through decreased effectiveness, and impacted productivity through interference in the coordination of care, thus decreasing clinical adoption of the monitoring system. CONCLUSIONS: Patient monitoring with eHealth technology in surgical wards has the potential to improve patient outcomes. However, proper planning that includes engagement of front-line nurses, installation of appropriate wireless network infrastructure, and use of comfortable cableless devices is required to maximize the potential of eHealth monitoring. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907255; https://clinicaltrials.gov/ct2/show/NCT02907255.

Vital sign monitoring with continuous pulse oximetry and wireless clinical notification after surgery (the VIGILANCE pilot study)-a randomized controlled pilot trial.

BACKGROUND: Respiratory depression is a serious perioperative complication associated with morbidity and mortality. Recently, technology has become available to wirelessly monitor patients on regular surgical wards with continuous pulse oximetry and wireless clinician notification with alarms. When a patient's SpO2 falls below a set threshold, the clinician is notified via a pager and may intervene earlier to prevent further clinical deterioration. To date, the technology has not been evaluated with a randomized controlled trial (RCT). METHODS: We designed a parallel-group unblinded pilot RCT of a wireless monitoring system on two surgical wards in an academic teaching hospital. Postsurgical patients with an anticipated length of stay of at least 1 day were included and randomized to standard care or standard care plus wireless respiratory monitoring for up to a 72-h period. The primary outcomes were feasibility outcomes: average patients recruited per week and tolerability of the system by patients. Secondary outcomes included (1) respiratory events (naloxone administration for respiratory depression, ICU transfers, and cardiac arrest team activation) and (2) system alarm types and details. The analysis of the outcomes was based on descriptive statistics and estimates reported using point (95% confidence intervals). Criteria for success of feasibility were recruitment of an average of 15 patients/week and 90% of the patients tolerating the system. RESULTS: The pilot trial enrolled 250 of the 335 patients screened for eligibility, with 126 and 124 patients entering the standard monitoring and wireless groups, respectively. Baseline demographics were similar between groups, except for slightly more women in the wireless group. Average patient recruitment per week was 14 95% CI [12, 16] patients. The wireless monitoring was quite tolerable with 86.6% (95% CI 78.2-92.7%) of patients completing the full course, and there were no other adverse events directly attributable to the monitoring. With regard to secondary outcomes, the respiratory event rate was low with only 1 event in the wireless group and none in the control group. The average number of alarms per week was 4.0 (95% CI, 1.6-6.4). CONCLUSIONS: This pilot study demonstrated adequate patient recruitment and high tolerability of the wireless monitoring system. A full RCT that is powered to detect patient important outcomes such as respiratory depression is now underway. TRIAL REGISTRATION: ClinicalTrials.gov, Registration number NCT02907255, registered 7 September 2016-retrospectively registered.

Perioperative Pregabalin and Intraoperative Lidocaine Infusion to Reduce Persistent Neuropathic Pain After Breast Cancer Surgery: A Multicenter, Factorial, Randomized, Controlled Pilot Trial.

Persistent postsurgical pain is defined as pain localized to the area of surgery of a duration of ≥2 months and is, unfortunately, a common complication after breast cancer surgery. Although there is insufficient evidence to support any preventative strategy, prior literature suggests the possible efficacy of intravenous lidocaine and perioperative pregabalin in preventing persistent pain after surgery. To determine feasibility of conducting a larger definitive trial, we conducted a multicenter 2 × 2 factorial, randomized, placebo-controlled pilot trial of 100 female patients undergoing breast cancer surgery. Patients were randomized to receive an intraoperative lidocaine infusion (1.5 mg/kg bolus followed by 2 mg/kg/h) or placebo and perioperative pregabalin (300 mg preoperatively, 75 mg twice daily for 9 days) or placebo. All feasibility criteria were surpassed; recruitment of 100 patients was accomplished within 42 weeks, with a follow-up rate of 100% and study drug compliance of ≥80%. At 3 months, 53% of patients reported persistent neuropathic pain. Although there was no interaction between lidocaine and pregabalin, lidocaine decreased the development of persistent neuropathic pain (43.1% vs 63.3%; relative risk = .68; 95% confidence interval = .47-1.0). Pregabalin did not reduce persistent pain (60% vs 46%; relative risk = 1.3; 95% confidence interval = .90-1.90) and neither pregabalin nor lidocaine impacted acute postoperative pain, opioid consumption, pain interference, or quality of life. Our pilot trial successfully demonstrated feasibility and provided promising data for conducting further trials of intraoperative lidocaine infusions during breast cancer surgeries. Clinical trial number: NCT02240199 PERSPECTIVE: This article reports the findings of a pilot randomized, controlled trial evaluating the effects of perioperative pregabalin and intraoperative lidocaine infusions in patients undergoing breast cancer surgery. This trial demonstrated the feasibility of conducting a larger trial and provided promising data that these interventions may decrease the development of persistent pain.

Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial.

Background: Electronic data collection is increasingly available as a means to collect pain-related clinical trial data; however, effectiveness and costs relative to traditional data collection are uncertain. Aims: The aim of this study was to evaluate data quality, protocol adherence, satisfaction, and resource requirements of electronic data collection (i.e., Internet-based electronic submission) compared to traditional data collection methods (i.e., paper-based diaries and telephone interviews) in a perioperative factorial randomized controlled trial. Methods: This study was an open-label two-arm parallel randomized controlled trial. Women (18-75 years) undergoing breast cancer surgery were allocated to either electronic or traditional data collection and completed pain-related questionnaires at baseline, postoperative period, and 3-month follow-up (NCT02240199). Results: We acquired outcome data at all time points from 78 randomized patients, 38 in the electronic group and 40 in the traditional group. The number of data queries (e.g., erroneously entered data) per patient was higher in the electronic data group (4.92 [SD = 4.67] vs. 1.88 [SD = 1.51]; P < 0.001). No between-group differences were observed for compliance with medications, data completeness, loss to follow-up, or patient or research assistant satisfaction. More research assistant time per patient was spent collecting data in the traditional group (42.6 min [SD = 12.8] vs. 9.92 min [SD = 7.6]; P < 0.001); however, costs per patient were higher in the electronic group ($176.85 [SD = 2.90] vs. $16.33 [SD = 4.90]; P < 0.001). Conclusion: Electronic data collection is feasible for perioperative pain clinical trials. Additional trials, including different surgical populations, are needed to confirm our findings and optimize use of electronic data capture methods.

Contexte: La collecte électronique de données est de plus en plus disponible en tant que moyen de recueillir les données dans le cadre d'essais cliniques liés à la douleur; toutefois, l'efficacité et le coût de cette méthode, comparativement à la collecte de données traditionnelle, sont incertains.But: Évaluer la qualité des données, le respect du protocole, la satisfaction et les ressources requises dans le cadre de la collecte électronique de données (i.e. la transmission électronique par Internet) comparativement aux méthodes de collecte de données traditionnelles (c.-à.-d les cahiers papier et les entrevues téléphoniques) dans un essai randomisé contrôllé factoriel périopératoire.Méthodes: Cette étude était un essai contrôlé randomisé ouvert parallèle à deux volets. Des femmes (de 18 à 75 ans) subissant une chirurgie pour traiter un cancer du sein ont été réparties en deux groupes, soit celui de la collecte életronique de données et celui de la collecte traditionnelle de données. Elles ont ensuite répondu à des questionnaires liés à la douleur au départ, pendant la période post-opératoire et au bout de trois mois (NCT02240199).Résutats: Nous avons receuilli les données de 78 patientes randomisées à chaque point dans le temps : 38 patientes dans le groupe électronique et 40 patientes dans le groupe traditionnel. Le nombre de questions relatives aux données (ex.: données saisies de manière erronée) par patiente était plus élevé dans le groupe de données électroniques (4,92, É.-T. 4,67 comparativement à 1,88, É.-T. 1,51; p < 0,001). Aucune différence n'a été observée entre les groupes en ce qui concerne l'observance du traitement médicamenteux, l'exhaustivité des données, le nombre de patientes perdues de vue et la satisfaction des patientes ou des assistantes de recherche. Les assistants de recherche ont passé plus de temps par patiente pour recueillir les données dans le groupe traditionnel (42,6 minutes É.-T. 12,8 comparativement à 9,92 minutes É.-T. 76; p < 0,001); toutefois, le coût par patiente était plus élevé dans le groupe électronique (176,85 $ É.-T. 2,90 comparativement à 16,33 $ É.-T. 4,90; p < 0,001).Conclusion: La collecte électronique de données est réalisable dans le cadre d'essais cliniques portant sur la douleur périopératoire. Des essais supplémentaires, y compris auprès de différentes populations de patients chirurgicaux, sont nécessaires pour confirmer nos résultats et optimiser l'utilisation de méthodes éectroniques de saisie de données.

Optimizing Pain and Rehabilitation After Knee Arthroplasty: A Two-Center, Randomized Trial.

BACKGROUND: This randomized trial compared (1) continuous femoral nerve block (cFNB), (2) single femoral nerve block (sFNB), and (3) local infiltration analgesia (LIA) with respect to analgesic and functional outcomes after primary tricompartmental knee arthroplasty (TKA). METHODS: One hundred twenty patients undergoing primary tricompartmental knee arthroplasty were randomly assigned to 1 of 3 interventions for postoperative analgesia: (1) cFNB-preoperative bolus of ropivacaine 0.5% 20 mL followed by ropivacaine 0.2% 5 mL per hour for 48 hours; (2) sFNB-preoperative bolus of ropivacaine 0.5% 20 mL with placebo 0.9% saline 5 mL per hour for 48 hours; or (3) LIA-intraoperative tricompartmental injection of ropivacaine 0.2% (150 mL) with epinephrine (10 µg/mL) and ketorolac 30 mg with femoral placebo 0.9% saline 20 mL preoperative bolus and 0.9% saline placebo 5 mL per hour for 48 hours. All participants received an identical, standardized, postoperative multimodal analgesic regimen. Participants, health care providers, data collectors, and analysts were blinded. All participants received identical perineural catheters and perineural/LIA solution (depending on randomized intervention) to maintain blinding. The primary outcome measure was numeric rating scale for pain (NRS) during physiotherapy on postoperative day (POD) 2 at 9:00 AM. Secondary outcomes included opioid consumption, NRS on POD 1 (rest/physiotherapy/worst), functional outcomes, and block complications. RESULTS: For the primary outcome, pain during physiotherapy on POD 2 at 9:00 AM, the overall analysis of covariance (ANCOVA) was significant (P = .049), but pairwise comparisons did not demonstrate any significant differences between treatment arms. NRS was 4.6 (95% confidence interval [CI], 3.3-6.0) for the cFNB group, 4.6 (95% CI, 3.3-6.0) for the sFNB group, and 3.4 (95% CI, 2.2-4.8) for the LIA group. The following is the mean difference in NRS on POD 2 at 9:00 AM among groups: cFNB-LIA (1.2, 95% CI, -0.1 to 2.5; P = .073); sFNB-LIA (1.2, 95% CI, -0.2 to 2.5; P = .097); cFNB-sFNB (0.0, 95% CI, -1.3 to 1.4; P = .996). There were no statistically significant differences between groups in cumulative 48-hour opioid consumption or functional outcomes. cFNB and LIA were superior to sFNB for NRS on POD 1 for worst pain experienced and pain during physiotherapy, respectively. There were no adverse events associated with study procedures reported among participants in the 3 groups. CONCLUSIONS: Our findings suggest no clinically significant differences between cFNB, LIA, and sFNB for pain during physiotherapy on POD 2 after TKA. Secondary analyses suggest that cFNB and LIA are superior to sFNB for early analgesic outcomes (NRS on POD 1) after TKA.

Postoperative epidural analgesia for patients undergoing pectus excavatum corrective surgery: a 10-year retrospective analysis.

INTRODUCTION: Managing postoperative pain in patients undergoing minimally invasive pectus excavatum repair (Nuss procedure) is challenging but essential in facilitating ambulation and minimizing the length of stay. Although multiple epidural regimens with varying opioids are presently used for pain management, there is currently no clinical consensus regarding which epidural regimen provides the best analgesia outcomes with the fewest side effects. This 10-year retrospective cohort study was performed to compare the quality of analgesia and the incidence of side effects associated with the three most common epidural regimens used at a tertiary care children's hospital, in patients undergoing the Nuss procedure. METHODS: Seventy-two pediatric patients were identified as having been treated with one of three epidural regimens for postoperative pain management following the Nuss procedure: Group A (n=12) received 0.125% bupivacaine and 5 µg/mL fentanyl, Group B (n=21) received 0.125% bupivacaine and 10 µg/mL hydromorphone, and Group C (n=39) received 0.1% ropivacaine and 20 µg/mL hydromorphone. Our primary outcome was maximal daily pain scores (numerical rating scale 0-10), with an analytical focus on postoperative day 1 scores. The primary outcome was analyzed using linear regression. The secondary outcomes included the length of stay, side-effect profiles as reflected by the number of treatments for nausea and pruritus, pain scores according to epidural site insertion, occurrence of breakthrough pain, and presence of severe pain throughout their hospital stay. Secondary outcomes were analyzed using linear or logistic regression adjusted for pain scores at baseline. The criterion for statistical significance was set a priori at alpha =0.05. RESULTS: Group A had significantly higher day-1 pain scores (score 5.42/10) than Group B (4.52/10; P=0.030) and Group C (4.49/10; P=0.015) after adjusting for baseline pain and age. No significant difference in maximum daily pain scores was found between groups during postoperative days 2-5. Among secondary outcomes, Group C had a significantly lower incidence of nausea/vomiting than Group B (P=0.003). There was also significantly more severe pain in Group A than in Group C (P=0.031). No significant difference was found between the three groups for the incidence of pruritus, critical events, breakthrough pain, or patient satisfaction. CONCLUSION: There is no significant difference in managing postoperative pain overall between the three epidural regimens employed at our center. However, in managing day-1 postoperative pain and minimizing nausea/vomiting, our study suggests that a hydromorphone-ropivacaine epidural regimen appears to have more favorable results than a fentanyl-bupivacaine regimen or a hydromorphone-bupivacaine regimen.

The impact of transitioning from a 24-hour to a 16-hour call model amongst a cohort of Canadian anesthesia residents at McMaster University - a survey study.

PURPOSE: The primary objective of this study was to assess anesthesia residents' opinions and perceptions on wellness/burnout, fatigue, education, and patient safety after the initiation of a reduced call model (16-hour call). METHODS: A prospective cohort study was conducted at three time points during the 2013-2014 academic year. A web-based questionnaire consisting of 23 questions was electronically distributed to all anesthesia residents from postgraduate years (PGY) 1 to 5 who were part of the active call roster (n=84) at McMaster University in Hamilton, Ontario. Descriptive summaries were calculated, counts and percentages were used for categorical variables, and answers to open text questions were reviewed for themes. RESULTS: A response rate of 67% was obtained for this study. A majority of anesthesia residents (65%) approved of 16-hour call, felt that their overall quality of life as a senior resident (PGY3 or greater) or junior resident (PGY2 and below) had improved (73% and 55%, respectively), and reported overall feeling less fatigued. Most respondents indicated that the quality of education remained unchanged (47%), or had improved (31%). And most felt better prepared for the royal college exam (52%). Most felt patient safety had improved or was unchanged (both 48%). CONCLUSION: The study demonstrates that 16-hour call improved resident wellness, reduced burnout and fostered an environment where residents are less fatigued and more satisfied with their educational experience promoting an environment of patient safety. Overall, the anesthesia residency group demonstrated that not only is 16-hour call preferred but beneficial.

Randomized controlled trial of gabapentin as an adjunct to perioperative analgesia in total hip arthroplasty patients.

PURPOSE: Gabapentin was investigated as a single-dose adjunct to morphine for postoperative pain management. The primary objective was to determine if gabapentin given preoperatively and for two days postoperatively as part of multimodal analgesia would decrease postoperative morphine consumption in patients undergoing primary total hip arthroplasty (THA). METHODS: The study group included 102 patients aged 19-90 years who were undergoing primary THA in a single joint with no contraindications to the study medications, no chronic pain syndrome, and no chronic opioid use. Intervention group patients (n = 48) received gabapentin 600 mg po preoperatively and 200 mg postoperatively on the day of surgery. They were continued on gabapentin at 200 mg three times daily for two days. Control group patients (n = 54) received placebo in a similar fashion. Preoperatively, all patients were given 30 mg of ketorolac intravenously and acetaminophen 1000 mg po. Postoperatively, they received intravenous patient-controlled analgesia with morphine, along with ketorolac 15 mg iv and acetaminophen 1000 mg po every six hours. RESULTS: The primary outcome was mean (SD) postoperative morphine consumption at 72 hr which was 55.8 (39.2) mg in the gabapentin groups vs 60.7 (37.2) mg for the control group (mean difference, -4.91 mg, 95% confidence intervals [CI]: -21.2 to 11.35; P = 0.550). There were no significant differences between the groups regarding secondary outcomes: pain scores, side effects, range of motion. Patient satisfaction on day 3 was more favourable in the placebo group. Length of hospitalization was marginally shorter in the placebo group. CONCLUSIONS: This trial indicated that gabapentin treatment had no clinically important reduction in postoperative morphine consumption at 72 hr in patients undergoing THA. Multimodal analgesia may account for the similar primary and secondary outcomes found in the groups. This trial was registered at ClinicalTrials.gov, number: NCT01307202.

Lumbar transversus abdominis plane block: the role of local anesthetic volume and concentration-a pilot, prospective, randomized, controlled trial.

BACKGROUND: The lumbar transversus abdominis plane (TAP) block has become an optional part of multimodal analgesia following several abdominal surgeries. There remains a lack of consensus regarding the extent of dermatomal blockade following lumber TAP block, as well as the optimal local anesthetic volumes and concentrations. The objectives of this pilot trial were to assess the feasibility of conducting a similar full-scale trial and gather information on relevant clinical outcomes, namely whether greater local anesthetic volumes would lead to more cephalad dermatomal blockade. METHODS: The study was a prospective, double-blinded pilot randomized controlled trial (RCT) with three arms, each representing different local anesthetic volumes: 20 ml 0.5% ropivacaine, 30 ml 0.33% ropivacaine, and 40 ml 0.25% ropivacaine. We planned to recruit 30 females undergoing total abdominal hysterectomy for non-malignant pathology, who would then receive bilateral ultrasound-guided midaxillary TAP blocks at the completion of surgery. Randomized patients would be followed for 48 h post-block and would receive multimodal analgesia. The primary outcomes were measurements of patient recruitment and safety, to inform the feasibility of a larger trial. The main secondary outcome was the clinically pertinent endpoint of dermatomal blockade, which was assessed by loss of sensation to ice and pinprick. RESULTS: Our target sample size was reached in 8 months, and the recruitment rate was 52% (31/60). A total of 58 TAP blocks were performed among 29 patients. All but one of the patients who received interventions were successfully followed and assessed up to 48 h. No patient safety-related adverse events were reported during the study period. The mean highest dermatome blocked in each group at any time point was T8. The 20 ml 0.5% ropivacaine group achieved a T9-L1 block that lasted for 48 h. The 30 ml 0.33% ropivacaine group had a sensory block from T9-L1 that regressed to T10-T12 between 24 and 48 h. The 40 ml 0.25% ropivacaine group reported an initial sensory block from T9-T12 that regressed by 24 h to include only the T12 dermatome. CONCLUSIONS: This pilot study demonstrated that the study design is feasible and safe to be carried to a full-scale RCT. The preliminary clinical findings showed that increasing the volume, while maintaining a constant dose, of local anesthetic does not appear to extend the height of dermatomal blockade following midaxillary TAP block. This finding needs to be confirmed in future studies. TRIAL REGISTRATION: ClinicalTrials.gov registration is: NCT01307215.

Hamilton acute pain service safety study: using root cause analysis to reduce the incidence of adverse events.

BACKGROUND: Although intravenous patient-controlled analgesia opioids and epidural analgesia offer improved analgesia for postoperative patients treated on an acute pain service, these modalities also expose patients to some risk of serious morbidity and even mortality. Root cause analysis, a process for identifying the causal factor(s) that underlie an adverse event, has the potential to identify and address system issues and thereby decrease the chance of recurrence of these complications. METHODS: This study was designed to compare the incidence of adverse events on an acute pain service in three hospitals, before and after the introduction of a formal root cause analysis process. The "before" cohort included all patients with pain from February 2002 to July 2007. The "after" cohort included all patients with pain from January 2009 to December 2009. RESULTS: A total of 35,384 patients were tracked over the 7 yr of this study. The after cohort showed significant reductions in the overall event rate (1.47 vs. 2.35% or 1 in 68 vs. 1 in 42, the rate of respiratory depression (0.41 vs. 0.71%), the rate of severe hypotension (0.78 vs. 1.34%), and the rate of patient-controlled analgesia pump programming errors (0.0 vs. 0.08%). Associated with these results, the incidence of severe pain increased from 6.5 to 10.5%. To achieve these results, 26 unique recommendations were made of which 23 being completed, 1 in progress, and 2 not completed. CONCLUSIONS: Formal root cause analysis was associated with an improvement in the safety of patients on a pain service. The process was effective in giving credibility to recommendations, but addressing all the action plans proved difficult with available resources.

Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial.

PURPOSE: This study assessed whether gabapentin given preoperatively and for two days postoperatively (in addition to patient-controlled analgesia [PCA] morphine, acetaminophen, and ketorolac) is effective in reducing morphine requirements and moderating pain scores when compared with placebo for primary total knee arthroplasty. METHODS: This single-centre double-blind randomized controlled trial was undertaken in patients who underwent primary total knee arthroplasty. All subjects received acetaminophen 1,000 mg and ketorolac 15 mg po preoperatively. Postoperatively, subjects received PCA morphine, acetaminophen 1,000 mg every six hours, and ketorolac 15 mg po every six hours. Subjects received either gabapentin 600 mg po preoperatively followed by 200 mg po every eight hours for two days or matching placebo. The primary outcome was cumulative morphine consumption at 72 hr following surgery. Secondary outcome measures included pain scores and patient satisfaction. RESULTS: There were 52 subjects in the gabapentin group and 49 subjects in the placebo group. The average cumulative morphine consumption at 72 hr postoperatively was 66.3 mg in the gabapentin group and 72.5 mg in the placebo group (difference -6.2 mg; 95% confidence interval -29.1 to 16.8 mg; P = 0.59). Mean pain scores at rest, with passive movement, or with weight bearing were similar in both groups at corresponding time periods for the first three days following surgery. In addition, mean patient satisfaction scores and hospital length of stay were similar in the two groups. CONCLUSION: Gabapentin 600 mg po given preoperatively followed by 200 mg po every eight hours for two days has no effect on postoperative morphine consumption, pain scores, patient satisfaction, or length of hospital stay. This trial is registered at ClinicalTrials.gov NCT01307202.

Continuous lumbar transversus abdominis plane block may spread to supraumbilical dermatomes.

PURPOSE: The transversus abdominis plane block is an interfascial block intended to target nerves supplying the abdominal wall. It has been shown to reduce pain and postoperative opioids in abdominal surgeries. We present the case of a high-risk patient in whom bilateral continuous lumbar transversus abdominis plane blocks provided effective postoperative analgesia following infraumbilical midline laparotomy. CLINICAL FEATURES: A 59-yr-old woman with coronary artery disease, severe peripheral vascular disease, and mild to moderate obstructive sleep apnea underwent a total abdominal hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node dissection via an infraumbilical midline laparotomy. Bilateral ultrasound-guided lumbar transversus abdominis plane blocks with catheters were sited intraoperatively. Using only a continuous local anesthetic infusion in the postoperative period, the patient required no systemic opioids or acetaminophen for 81 hr. A sensory block level of T6-L1, higher than that reported following a single-shot technique, remained for 24 hr following infusion discontinuation and finally normalized after 33 hr. CONCLUSIONS: Lumbar transversus abdominis plane blocks with continuous infusions may offer an effective alternative to epidural blockade and systemic opioids in high-risk patients. Additionally, given the extensive somatosensory block, this technique may have an analgesic role following abdominal incisions involving not only the infraumbilical region but also supraumbilical sites.

Impact of a comprehensive safety initiative on patient-controlled analgesia errors.

BACKGROUND: Adverse drug events related to patient-controlled analgesia (PCA) place patients at risk. METHODS: We reviewed all critical incident reports at three tertiary care hospitals dated January 1, 2002, to February 28, 2009. In this longitudinal cohort study, critical incidents attributable to PCA errors were identified, and each incident was investigated. A safety intervention was implemented in February 2006 and involved new PCA pumps, new preprinted physician orders, nursing and patient education, a manual independent double-check, and a formal nursing transfer of accountability. RESULTS: A total of 25,198 patients were treated with PCA during this study, and 62 errors were found (0.25%), with 21 (0.08%) involving pump programming. All errors occurred before the safety interventions were put in place. Compared with the preintervention period, the odds ratio of a PCA error postintervention was 0.28 (95% CI = 0.14, 0.53; P < 0.001) whereas the odds ratio of a pump-programming error postintervention was 0.05 (95% CI = 0.001, 0.30; P < 0.001). Programming the wrong drug concentration was the most common programming error (10 of 21). Improper setup of intravenous tubing was also common (8 of 62), with one incident leading to respiratory arrest. Most PCA errors resulted in no harm, but there was negative impact to patients 34% of the time. CONCLUSION: At less than 1%, the incidence of PCA errors is relatively low. Most errors occur during PCA administration. Safety can be improved by addressing equipment, education, and process issues.

Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials.

BACKGROUND: Femoral nerve blockade (FNB) is a common method of analgesia for postoperative pain control after total knee arthroplasty. We conducted a systematic review to compare the analgesia outcomes in randomized controlled trials that compared FNB (with and without sciatic nerve block) with epidural and patient-controlled analgesia (PCA). METHODS: We identified 23 randomized controlled trials that compared FNB with PCA or epidural analgesia. These studies included 1,016 patients, 665 with FNB, 161 with epidural, and 190 with PCA alone. RESULTS: All 10 studies of single-shot FNB (SSFNB) used concurrent PCA opioids. SSFNB was found to reduce PCA morphine consumption at 24 h (-19.9 mg, 95% credible interval [CrI]: -35.2 to -4.6) and 48 h (-38.0 mg, 95% CrI: -56.0 to -19.7), pain scores with activity (but not at rest) at 24 and 48 h (-1.8 visual analog pain scale, 95% CrI: -3.3 to -0.02 at 24 h; -1.5 visual analog pain scale, 95% CrI: -2.9 to -0.02 at 48 h) and reduce the incidence of nausea (0.37 odds ratio, 95% CrI: 0.1 to 0.9) compared with PCA alone. SSFNB had similar morphine consumption and pain scores compared with SSFNB plus sciatic nerve block, and SSFNB plus continuous FNB. CONCLUSIONS: SSFNB or continuous FNB (plus PCA) was found to be superior to PCA alone for postoperative analgesia for patients having total knee arthroplasty. The impact of adding a sciatic block or continuous FNB to a SSFNB needs to be studied further.

Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study.

BACKGROUND: Early randomized controlled trials have suggested that neuraxial blockade may reduce cardiorespiratory complications after non-cardiothoracic surgery, but recent larger trials have been inconclusive. We conducted a pilot study to assess the feasibility of conducting a large multicentre randomized controlled trial in Canada. METHODOLOGY/PRINCIPAL FINDINGS: After Research Ethics Board approvals from the participating institutions, subjects were recruited if they were > or = 45 years old, had an expected hospital stay > or = 48 hours, were undergoing a noncardiothoracic procedure amenable to epidural analgesia, met one of six risk criteria, and did not have contraindications to neuraxial blockade. After informed consent, subjects were randomly allocated to combined epidural analgesia (epidural group) and neuraxial anesthesia, with or without general anesthesia, or intravenous opioid analgesia (IV group) and general anesthesia. The primary outcomes were the rate of recruitment and the percents of eligible patients recruited, crossed over, and followed completely. Feasibility targets were defined a priori. A blinded, independent committee adjudicated the secondary clinical outcomes. Subjects were followed daily while in hospital and then at 30 days after surgery. Analysis was intention-to-treat. Over a 15-month period, the recruitment rate was 0.5+/-0.3 (mean+/-SEM) subjects per week per centre; 112/494 (22.7%) eligible subjects were recruited at four tertiary-care teaching hospitals in Canada. Thirteen (26.5%) of 49 subjects in the epidural group crossed over to the IV group; seven (14.3%) were due to failed or inadequate analgesia or complications from epidural analgesia. Five (9.8%) of 51 subjects in the IV group crossed over to the epidural group but none were due to inadequate analgesia or complications. Ninety-eight (97.0%) of 101 subjects were successfully followed up until 30 days after their surgery. CONCLUSION/SIGNIFICANCE: Of the criteria we defined for the feasibility of a full-scale trial, only the follow-up target was met. The other feasibility outcomes did not meet our preset criteria for success. The results suggest that a large multicentre trial may not be a feasible design to study the perioperative effects of neuraxial blockade. TRIAL REGISTRATION: ClinicalTrials.gov NCT 0221260 Controlled-Trials.com ISRCTN 35629817.

The OxyMask(™) development and performance in healthy volunteers.

BACKGROUND: The OxyMask(™) is a unique, open-style, oxygen mask that was originally developed in 2005. The original mask was modified, using computational fluid dynamics numerical simulations, with the goal of allowing it to produce a wider range of FiO(2). This analysis was used to guide the modification of the mask shell and the location for the oxygen diffuser. METHODS: The new OxyMask was attached to 10 healthy subjects and used to deliver escalating levels of oxygen (1.5, 2, 2.5, 3, 5, 10, 15, 20, 25 and 30 LPM) for 90 seconds at each level and the resulting FiO(2) was recorded (at the lips) from 5 consecutive measurements at each oxygen flow rate. RESULTS: Mean FiO(2) was 25.4% at 1.5 LPM of oxygen, 30.1% at 2 LPM, 36.5% at 2.5 LPM, 41.8% at 3 LPM, 57.6% at 5 LPM, 74.4% at 10 LPM, and 80.1% at 15 LPM. Each FiO(2) achieved at these escalating oxygen levels was significantly greater than all the previous levels. The mean FiO(2) was 82.8 at 20 LPM, 84.2% at 25 LPM and 84.3% at 30 LPM. All of these values on average were not significantly greater than the FiO(2) achieved with 15 LPM. In a few subjects a maximum FiO(2) of 90% was reached. CONCLUSION: The original OxyMask was successfully modified so that the second generation of the mask can provide a wide range of FiO(2), from 25% to 90%, while keeping its unique open design.

Morphine overdose from error propagation on an acute pain service.

PURPOSE: To highlight a case in which multiple errors occurred during programming and administration of analgesia via a patient-controlled analgesia (PCA) pump, and to formulate recommendations on how to avoid such errors in the future. CLINICAL FEATURES: Following lumbar surgery, a 43-yr-old woman was switched from epidural analgesia to a PCA pump. This change was associated with numerous errors at several points of delivery of her care. Errors included incorrect connection of the PCA adapter, incorrect pump programming, and communication lapses which resulted in a morphine overdose and subsequent respiratory arrest. The patient was promptly resuscitated, and she had an uneventful recovery. The event resulted in a complete review of pain management equipment and the training and education of staff using this equipment at our institution. CONCLUSION: This case highlights how multiple individual errors can combine to result in a serious adverse event. While equipment design was an important factor in this adverse event, human factors played a critical role at multiple levels.

Preoperative gabapentin for postoperative analgesia: a meta-analysis.

PURPOSE: Gabapentin's role in the treatment of chronic neuropathic pain is well known. What is less well established is its role for managing postoperative pain. In order to clarify whether gabapentin's utility in acute pain control is more than just theoretical, we conducted a meta-analysis of all randomized trials that addressed gabapentin's role in acute postoperative pain control. We specifically addressed whether gabapentin reduces pain scores, analgesia consumption, and/or analgesia-related side effects in the first 24 hr following surgery. SOURCE: We identified eight placebo-controlled, randomized controlled trials and conducted a meta-analysis using the primary outcomes of pain scores, total analgesia consumption, and side effects over a 24-hr period. PRINCIPLE FINDINGS: Patients who received gabapentin preoperatively reported significantly lower pain scores (-11.9 at rest and -11.0 with movement on a 100-point visual analogue scale) and opioid consumption (-14.7 mg of morphine in 24 hr) with no difference in the incidence of side effects. CONCLUSION: Although gabapentin given preoperatively decreases pain scores and analgesic consumption in the first 24 hr after surgery, the clinical significance of this finding has yet to be determined. This meta-analysis could not demonstrate a significant reduction in the incidence of side effects. Due to the small numbers enrolled in the studies, larger randomized control trials are warranted.