Exploratory study of VVZ-149, a novel analgesic molecule,in the affective component of acute postoperative pain after laparoscopic colorectal surgery

Study objectiveVVZ-149 is a small molecule that inhibits the glycine transporter type 2 and the serotonin receptor 5-hydroxytryptamine 2A. In the present study, we investigated the efficacy and safety of VVZ-149 as a single-use injectable analgesic for treating moderate to severe postoperative pain after colorectal surgery.DesignRandomized, parallel group, double-blind Phase 2 clinical trial (NCT02489526).Setting3 academic institutions in the United States.Patients60 patients undergoing laparoscopic colorectal surgery.InterventionsA continuous 8-h intravenous infusion of VVZ-149 Injections (n = 40) or placebo (n = 20) administered after emergence from anesthesia.MeasurementsThe outcome measures included pain intensity (PI), opioid consumption via patient-controlled analgesia (PCA), and rescue dosing provided “as needed”. Early rescue dosing with opioids postoperatively was associated with preoperative negative affect (anxiety, depression, and pain catastrophizing), enabling it to be used as an indirect measure of the affective component of pain. Efficacy outcomes were compared between treatment groups based on preoperative negative affect and early rescue dosing of opioids.Main resultsPostoperative PI was non-significantly lower in patients receiving VVZ-149 compared to those receiving placebo. The VVZ-149 group had a 34.2% reduction in opioid consumption for 24 h post-dose, along with fewer PCA demands. Somnolence and headache was higher in the intervention group. For patients characterized by high levels of preoperative negative affect, the VVZ-149 group experienced a significant pain reduction and 40% less opioid use compared to the placebo group.ConclusionsVVZ-149 resulted in a non-significant reduction of postoperative pain during the first 8 h after surgery. Post hoc analysis indicates that VVZ-149 may benefit patients with negative affect who otherwise have higher postoperative opioid use.Registration numberwww.clinicaltrials.gov, ID: NCT02489526.     

Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial

ObjectiveCompare transversus abdominis plane (TAP) blocks with liposomal bupivacaine were to epidural analgesia for pain at rest and opioid consumption in patients recovering from abdominal surgery.BackgroundERAS pathways suggest TAP blocks in preference to epidural analgesia for abdominal surgery. However, the relative efficacies of TAP blocks and epidural analgesia remains unknown.MethodsPatients having major abdominal surgery were enrolled at six sites and randomly assigned 1:1 to thoracic epidural analgesia or bilateral/4-quadrant TAP blocks with liposomal bupivacaine. Intravenous opioids were used as needed. Non-inferiority margins were a priori set at 1 point on an 11-point pain numeric rating scale for pain at rest and at a 25% increase in postoperative opioid consumption.ResultsEnrollment was stopped per protocol at 3rd interim analysis after crossing an a priori futility boundary. 498 patients were analyzed (255 had TAP blocks and 243 had epidurals). Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI: −0.12, 0.30; noninferiority P < 0.001). Opioid consumption during the initial 3 postoperative days in TAP patients was not non-inferior to epidurals, with an estimated ratio of geometric means of 1.37 (CI: 1.05, 1.79; non-inferiority P = 0.754). However, the absolute difference was only 21 mg morphine equivalents over the 3 days. Patients with epidurals were more likely to experience mean arterial pressures <65 mmHg than those given TAP blocks: 48% versus 31%, P = 0.006.ConclusionPain scores at rest during the initial three days after major abdominal surgery were similar. Patients assigned to TAP blocks required more opioid then epidural patients but had less hypotension. Clinicians should reconsider epidural analgesia in patients at risk from hypotension.Trial Registration: ClinicalTrials.gov Identifier: NCT02996227.     

Opioid administration in the prehospital setting for patients sustaining traumatic injuries: An evaluation of national emergency medical services data

IntroductionDespite concerns about long-term dependence, opioids remain the mainstay of treatment for acute pain from traumatic injuries. Additionally, early pain management has been associated with improved long-term outcomes in injured patients. We sought to identify the patterns of prehospital pain management across the United States.MethodsWe used 2019 national emergency medical services (EMS) data to identify the use of pain management for acutely injured patients. Opioid specific dosing was calculated in morphine milligram equivalents (MME). The effects of opioids as well as adverse events were identified through objective patient data and structured provider documentation.ResultsWe identified a total of 3,831,768 injured patients, 85% of whom were treated by an advanced life support (ALS) unit. There were 269,281 (7.0%) patients treated with opioids, including a small number of patients intubated by EMS (n = 1537; 0.6%). The median opioid dose was 10 MME [IQR 5–10] and fentanyl was the most commonly used opioid (88.2%). Patients treated with opioids had higher initial pain scores documented by EMS than those not receiving opioids (median: 9 vs 4, p<0.001), and had a median reduction in pain score of 3 points (IQR 1–5) based on the final prehospital pain score. Adverse events associated with opioid administration, including episodes of altered mental status (n = 453; 0.2%) and respiratory compromise (n = 252; 0.1%), were rare. For patients with severe pain (≥8/10), 27.3% of patients with major injuries (ISS ≥15) were treated with opioids, compared with 24.8% of those with moderate injuries (ISS 9–14), and 21.4% of those with minor (ISS 1–8) injuries (p<0.001).ConclusionThe use of opioids in the prehospital setting significantly reduced pain among injured patients with few adverse events. Despite its efficacy and safety, the majority of patients with major injuries and severe pain do not receive opioid analgesia in the prehospital setting.     

Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine

Study objectiveTo investigate efficacy and safety of liposomal bupivacaine (LB) transversus abdominis plane (TAP) block with or without intrathecal morphine (ITM) compared with ITM alone for postsurgical analgesia after cesarean delivery (CD).DesignMulticenter, open-label, randomized trial (NCT03853694).SettingOperating room.PatientsWomen with term pregnancy of 37 to 42 weeks scheduled for elective CD under spinal anesthesia.InterventionPatients were randomized 1:1:1 to LB 266 mg TAP block alone (LB group), ITM 50 μg followed by LB 266 mg TAP block (LB + ITM group), or ITM 150 μg alone (ITM group). All groups received the same postsurgical multimodal analgesic regimen.MeasurementsThe LB and LB + ITM groups were compared with the ITM group for all efficacy outcomes. Postsurgical opioid consumption in morphine milligram equivalents (MMEs) through 72 h was compared by assessing noninferiority before testing superiority. Postsurgical pruritus severity was assessed on an 11-point numerical rating scale.Main resultsBetween March 4, 2019, and January 10, 2020, 153 patients (LB, n = 52; LB + ITM, n = 48; ITM, n = 53) were enrolled. Baseline characteristics were comparable across groups. The LB group had statistically noninferior postsurgical opioid consumption through 72 h compared with the ITM group (least squares mean [LSM], 19.2 vs 16.4 MMEs; LSM treatment ratio, 1.17 [95% confidence interval (CI), 0.74–1.86]; noninferiority P < 0.0034) as did the LB + ITM group (LSM, 14.6 vs 16.4 MMEs; LSM treatment ratio, 0.89 [95% CI, 0.55–1.44]; noninferiority P < 0.0001). The LB and LB + ITM groups had significantly reduced pruritus severity scores through 12, 24, 48, and 72 h compared with the ITM group (P ≤ 0.0121). Adverse events occurred in 58%, 85%, and 81% of the LB, LB + ITM, and ITM groups, respectively.ConclusionsLB TAP block with or without ITM resulted in statistically noninferior postsurgical opioid consumption through 72 h, reduced pruritus, and favorable safety compared with ITM in women undergoing CD.     

Perioperative supplemental oxygen and oxidative stress in patients undergoing moderate- to high-risk major abdominal surgery – A subanalysis of randomized clinical trial

Study objectiveOxidative stress plays a pivotal role in the development and aggravation of cardiovascular diseases. The influence of intraoperative inspired oxygen concentrations on oxidative stress is still not entirely known. Therefore, we evaluated in this sub-study if supplemental oxygen affects the oxidation-reduction potential in patients at-risk for cardiovascular complications undergoing moderate- to high-risk major abdominal surgery.DesignSub-study of a prospective parallel-arm double-blinded single-center superiority randomized trial.SettingOperating room and postoperative recovery area.InterventionAdministration of 0.8 FiO₂ versus 0.3 FiO₂ throughout surgery and for the first two postoperative hours.MeasurementsThe primary outcome was the static oxidation-reduction potential (sORP) and the oxidation-reduction potential capacity (cORP) between both groups. The secondary outcome was the trend of sORP and cORP in the overall study population. We assessed sORP and cORP before induction of anesthesia, 2 h after induction of anesthesia, within 2 h after surgery and on the first and third postoperative day.Main results258 patients were analyzed. 128 patients were randomly assigned to the 80% oxygen group and 130 patients were randomly assigned to the 30% oxygen group. Postoperative sORP values did not differ significantly between the 80% and 30% oxygen group (effect estimate: −1.162 mV,95% CI: −2.584 to 0.260; p = 0.109). On average, we observed a change in sORP of 5.288 mV (95% CI:4.633 to 5.913, p < 0.001) per day. cORP values did not differ significantly between the 80% and 30% oxygen group (effect estimate: −0.015μC, (95%CI: −0.062 to 0.032; p = 0.524). On average, we observed a change in cORP values of −0.170μC (95%CI: −0.194 to −0.147, p < 0.001) per day.ConclusionIn contrast to previous reports, we could not find any evidence of an association between intraoperative supplemental oxygen and perioperative oxidative stress assessed by sORP and cORP.Trial registrationclinicaltrials.gov: NCT03366857 https://clinicaltrials.gov/ct2/show/NCT03366857?term=vienna&cond=oxygen&draw=2&rank=1     

Nasal continuous positive pressure versus simple face mask oxygenation for adult obese and obstructive sleep apnea patients undergoing colonoscopy under propofol-based general anesthesia without tracheal intubation: A randomized controlled trial

Study objectiveTo determine if a nasal positive airway pressure (nasal CPAP) mask would decrease the number of hypoxemic events in obese and obstructive sleep apnea patients undergoing colonoscopy.DesignSingle-center prospective randomized controlled trial.SettingTertiary academic center.PatientsWe enrolled 109 patients with diagnosis of obesity and/or obstructive sleep apnea scheduled to undergo colonoscopy under propofol general anesthesia without planned tracheal intubation.InterventionPatients were randomly allocated (1:1 ratio) to receive supplementary oxygen at a flow of 10 L/min, either through a nasal CPAP or a simple facemask.MeasurementsThe primary endpoint was the difference in the mean percentage of time spent with oxygen saturation below 90% between the two groups. Secondary outcomes included the need for airway maneuvers/interventions, average SpO2 during the case, duration and severity of oxygen desaturation, incidence and duration of procedural interruptions, and satisfaction and tolerance scores.Main results54 were allocated to the simple face mask and 55 to the nasal CPAP mask arms, respectively. A total of 6 patients experienced a hypoxemic event. Among these patients, the difference in the percentage of time spent with oxygen saturation below 90% was not clinically relevant (p = 1.0). However, patients in the nasal CPAP group required less chin lift (20% vs. 42.6%; p = 0.01) and oral cannula insertion (12.7% vs.29.6%; p = 0.03). The percentage of patients with at least one airway maneuver was higher in the simple face mask arm (68.5% vs. 41.8%; p = 0.005). Patient tolerance to device score was lower in the nasal CPAP group (8.85 vs. 9.56; p = 0.003).ConclusionsA nasal CPAP did not prevent hypoxemia and should not be used routinely for colonoscopy in obese or OSA patients if a simple face mask is an alternative therapy. However, potential advantages of its use include fewer airway maneuvers or interventions, which may be desirable in certain clinical settings.Trial registrationClinicaltrials.gov, identifier: NCT05175573.     

Variation in opioid utilization among neonates with gastroschisis

PurposeRepetitive painful stimuli and early exposure to opioids places neonates at risk for neurocognitive delays. We aimed to understand opioid utilization for neonates with gastroschisis.MethodsWe performed a retrospective review of infants with gastroschisis at a tertiary children's hospital (2017–2019). Multivariate linear regression was performed to analyze variations in opioid use.ResultsAmong 30 patients with gastroschisis, 33% were managed by primary suture-less closure, 7% by primary sutured closure, 40% by spring silo, and 20% by handsewn silo. The proportion of pain medication used was: morphine (89%), acetaminophen (8%), and fentanyl (3%). Opioids were used for a median of 6.5 days (range 0–20) per patient. Median total opioid administered across all patients was 2.2 morphine milligram equivalents (MME)/kg (IQR 0.7–3.3). Following definitive closure, median opioid use was 0.2 MME/kg (IQR 0.1–0.8). With multivariate regression, 45% of the variation in MME use was associated with the type of surgery after adjusting for weight, gestational age, and gender, p = 0.02. After definitive fascial closure, there was no significant variations in opioid use.ConclusionThere is a significant variation in the utilization of opioid, primarily prior to fascial closure. Understanding pain needs and standardization may improve opioid stewardship in infants with gastroschisis. 197/200Level of EvidenceLevel III     

The effect of hyperoxia on ventilation during recovery from general anesthesia: A randomized pilot study for a parallel randomized controlled trial

Study objectiveWhile supplemental O₂ inhalation corrects hypoxemia, its effect on post-anesthesia ventilation remains unknown. This pilot trial tested the hypothesis that hyperoxia increases the time spent with a transcutaneous PCO₂ (TcPCO₂) > 45 mmHg, compared with standard O₂ supplementation.DesignSingle-blinded, parallel two-arm randomized pilot trial.SettingUniversity hospital.Patients20 patients undergoing robotic-assisted laparoscopic nephrectomy.MeasurementsAfter institutional approval and informed consent, patients were randomized to receive O₂ titrated to arterial saturation (SpO₂): 90–94% (Conservative O₂, N =10), or to SpO₂ > 96% (Liberal O₂, N = 10) for up to 90 min after anesthesia. Continuous TcPCO₂, respiratory inductance plethysmography (RIP), and SpO₂, were recorded. We calculated the percentage of time at TcPCO₂ > 45 mmHg for each patient and compared the two groups using analysis of covariance, adjusting for sex, age, and body mass index. We also estimated the sample size required to detect the between-group difference observed in this pilot trial. RIP signals were used to calculate apnea/hypopnea index (AHI), which was then compared between two groups.Main resultsThe mean percentage of time with a TcPCO₂ > 45 mmHg was 80.6% for the Conservative O₂ (N=9) and 61.2% for the Liberal O₂ (N=10) group [between-group difference of 19.4% (95% CI: −18.7% to 57.6%), P = 0.140]. With an observed effect size of 0.73, we estimated that 30 participants per group are required, to demonstrate this difference with a power of 80% at a two-sided alpha of 5%. Means SpO₂ were 94.5% and 99.9% for the Conservative O₂ and the Liberal O₂ groups, respectively. AHI was significantly higher in the Conservative O₂, compared with the Liberal O₂ group (median AHI: 16 vs. 3; P = 0.0014).ConclusionsHyperoxia in the post-anesthesia period reduced the time spent at TcPCO₂ > 45 mmHg and significantly decreased AHI, while mean SpO₂ ranged inside the a priori defined limits.Trial registrationClinicalTrials.gov identifier: NCT04723433     

Perioperative supplemental oxygen and NT-proBNP concentrations after major abdominal surgery – A prospective randomized clinical trial

Study objectiveSupplemental oxygen is a simple method to improve arterial oxygen saturation and might therefore improve myocardial oxygenation. Thus, we tested whether intraoperative supplemental oxygen reduces the risk of impaired cardiac function diagnosed with NT-proBNP and myocardial injury after noncardiac surgery (MINS) diagnosed with high-sensitivity Troponin T.DesignParallel-arm double-blinded single-centre superiority randomized trial.SettingOperating room and postoperative recovery area.Patients260 patients over the age of 45 years at-risk for cardiovascular complications undergoing major abdominal surgery.InterventionAdministration of 80% versus 30% oxygen throughout surgery and for the first two postoperative hours.MeasurementsThe primary outcome was the postoperative maximum NT-proBNP concentration in both groups, which was assessed within 2 h after surgery, and on the first and third postoperative day. The secondary outcome was the incidence of MINS in both groups.Main results128 patients received 80% oxygen and 130 received 30% oxygen throughout surgery and for the first two postoperative hours. There was no significant difference in the median postoperative maximum NT-proBNP concentration between the 80% and the 30% oxygen group (989 pg.mL⁻¹ [IQR 499; 2005] and 810 pg.mL⁻¹ [IQR 409; 2386], effect estimate: 159 pg.mL⁻¹, 95%CI -123, 431, p = 0.704). There was no difference in the incidence of MINS between both groups. (p = 0.703).ConclusionsThere was no beneficial effect of perioperative supplemental oxygen administration on postoperative NT-proBNP concentration and MINS. It seems likely that supplemental oxygen has no effect on the release of NT-proBNP in patients at-risk for cardiovascular complications undergoing major abdominal surgery.Trial registrationClinicalTrials.gov: NCT 03366857.https://clinicaltrials.gov/ct2/results?cond=NCT+03366857&term=&cntry=&state=&city=&dist=     

Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter,randomized, parallel-group,controlled trial

Study objectiveAfter surgery, patients reported the delay in receiving help as the primary factor for poorly controlled pain. This study aimed to compare the effectiveness of patient management through two communication modalities: remote transmission (RT) versus bedside control (BC). We hypothesized that using remote technology for pump programming may provide the best postoperative infusion regimen for the patient's self-assessment of pain and adverse events.DesignA multicenter, randomized, parallel-group, controlled trial.SettingAnesthesiology department and orthopedic surgery ward at three university hospitals.PatientsEighty patients undergoing orthopedic surgery with postoperative perineural patient-controlled analgesia were included.InterventionsTwo groups (n = 40 for each group) were formed by randomization. In the postoperative period, perineural analgesia was followed up via an RT system or BC for 72 h.MeasurementsA nurse assessed daily pain, sensory and motor blocks and adverse events. Patients completed a questionnaire three times a day and alerted for any problem according to the group (RT system or nurses' follow-up). On the third postoperative day, the nurse removed the catheter, completed the final assessment, and collected the historical data from the pump. A physician's shorter response time to change the patient control analgesia (PCA) program was the primary endpoint.ResultsOf the 80 patients, 71 were analyzed (34 were randomized to the RT group and 37 to the BC group). Fifty-eight pump setting changes were noted. Analysis of repeated evaluations shows that mean time (SD) to change the PCA pump settings was significantly lower in the RT group (20 min (22.3 min)) than in the BC group (55.9 min (71.1 min)); mean difference [95% CI], −35.9 min [−74.3 to 2.4]); β estimation [95% CI], −34 [−63 to −6], p = 0.011). Pain relief, sensory and motor blocks did not differ between the groups: β estimation [95% CI], 0.1 [−0.4 to 0.6], p = 0.753; 0.5 [−0.4 to 1.4], p = 0.255; 0.9 [−0.04 to 1.8], p = 0.687, respectively. β = −34 [−63 to −6], p = 0.011). The consumption of ropivacaine, nurse workload and the cost of the analgesia regimen decreased in the RT group. No differences were noted in satisfaction scores or complication rates.ConclusionsThe response time for the physician to change the PCA program when necessary was shorter for patients using RT and alerts to the physician were more frequent compared with spot checks by nurses. RT helps to decrease nurses' workload, ropivacaine consumption, and costs but did not affect postoperative pain relief, complication rate, or patient-reported satisfaction score.IRB contact informationComité de Protection des Personnes, Sud Méditerranée III, Montpellier-Nîmes, France, registration number EudraCT A01698-35.Clinical trial numberClinicalTrials.gov ID:NCT02018068ProtocolThe full trial protocol can be accessed at Department of Anesthesiology and Critical Care Medicine, Medical Research and Statistics Unit, Lapeyronie University Hospital, Avenue Doten G Giraud, Montpellier, France. s-bringuierbranchereau@chu-montpellier.fr     

Lung-protective ventilation during Trendelenburg pneumoperitoneum surgery: A randomized clinical trial

Study objectiveTo assess the effects of a protective ventilation strategy during Trendelenburg pneumoperitoneum surgery on postoperative oxygenation.DesignsParallel-group, randomized trial.SettingOperating room of a university hospital, Italy.PatientsMorbidly obese patients undergoing Trendelenburg pneumoperitoneum gynaecological surgery.InterventionsParticipants were randomized to standard (SV: tidal volume = 10 ml/kg of predicted body weight, PEEP = 5 cmH₂O) or protective (PV: tidal volume = 6 ml/kg of predicted body weight, PEEP = 10 cmH₂O, recruitment maneuvers) ventilation during anesthesia.MeasurementsPrimary outcome was PaO₂/FiO₂ one hour after extubation. Secondary outcomes included day-1 PaO₂/FiO₂, day-2 respiratory function and intraoperative respiratory/lung mechanics, assessed through esophageal manometry, end-expiratory lung volume (EELV) measurement and pressure-volume curves.Main resultsSixty patients were analyzed (31 in SV group, 29 in PV group). Median [IqR] tidal volume was 350 ml [300–360] in PV group and 525 [500–575] in SV group. Median PaO₂/FiO₂ one hour after extubation was 280 mmHg [246–364] in PV group vs. 298 [250–343] in SV group (p = 0.64). Day-1 PaO₂/FiO_2, day-2 forced vital capacity, FEV-1 and Tiffenau Index were not different between groups (all p > 0.10). Intraoperatively, 59% of patients showed complete airway closure during pneumoperitoneum, without difference between groups: median airway opening pressure was 17 cmH₂O. In PV group, airway and transpulmonary driving pressure were lower (12 ± 5 cmH₂O vs. 17 ± 7, p < 0.001; 9 ± 4 vs. 13 ± 7, p < 0.001), PaCO₂ and respiratory rate were higher (48 ± 8 mmHg vs. 42 ± 12, p < 0.001; 23 ± 5 breaths/min vs. 16 ± 4, p < 0.001). Intraoperative EELV was similar between PV and SV group (1193 ± 258 ml vs. 1207 ± 368, p = 0.80); ratio of tidal volume to EELV was lower in PV group (0.45 ± 0.12 vs. 0.32 ± 0.09, p < 0.001).ConclusionsIn obese patients undergoing Trendelenburg pneumoperitoneum surgery, PV did not improve postoperative oxygenation nor day-2 respiratory function. PV was associated with intraoperative respiratory mechanics indicating less injurious ventilation. The high prevalence of complete airway closure may have affected study results.Trial registrationProspectively registered on http://clinicaltrials.gov NCT03157479 on May 17th, 2017.     

Transcutaneous electrical acupoint stimulation before surgery reduces chronic pain after mastectomy: A randomized clinical trial

Study objectiveDespite multiple interventions, the incidence of chronic pain after mastectomy could be as high as 50% after surgery. This study aimed to determine the efficacy of transcutaneous electrical acupoint stimulation (TEAS) before anesthesia induction in reducing chronic pain and to compare the effect of combined acupoint TEAS with that of single acupoint TEAS.DesignA multicenter randomized clinical trial.SettingThe study was conducted at six medical centers in China from May 2016 to April 2018. Final follow-up was on October 26, 2018.ParticipantsEligible patients were women scheduled for radical mastectomy under general anesthesia.InterventionsPatients were randomly and equally grouped into sham control (n = 188), single acupoint (PC6, n = 198), or combined acupoints (PC6 and CV17, n = 190) TEAS groups using a centralized computer-generated randomization system. TEAS was applied for 30 min before anesthesia induction. The sham-operated control group received electrode attachment but without stimulation. Anesthesiologists, surgeons, and outcome assessors were blinded to the interventions.MeasuresThe primary endpoint was the incidence of chronic pain 6 months after surgery. Incidences were compared among the groups using the unadjusted χ² test.ResultsOf the 576 randomized patients, 568 completed the trial. In the intention-to-treat analysis, post-mastectomy pain at 6 months was reported in 42 of 190 patients (22.1%) in the combined acupoints group, 65 of 188 patients (34.6%) in the sham-operated group (P = 0.007; relative risk [RR], 95% confidence interval [CI]: 0.68, 0.52–0.89), and 72 of 198 patients (36.4%) in the single acupoint group (P = 0.002; RR, 95% CI: 0.72, 0.55–0.93). Remifentanil consumption during surgery and postoperative nausea and vomiting at 24 h after surgery were lower in the combined acupoint group than that in the sham-operated group.ConclusionTEAS at combined acupoints before surgery was associated with reduced chronic pain 6 months after surgery.Trial registration: Clinicaltrials.gov identifier: NCT02741726. Registered on April 13, 2016.     

Bilateral continuous erector spinae plane block using a programmed intermittent bolus regimen versus intrathecal morphine for postoperative analgesia in living donor laparoscopic hepatectomy: A randomized controlled trial

Study objectiveTo determine if continuous bilateral erector spinae plane (ESP) blocks would improve the postoperative analgesia in the first 48 h after laparoscopic donor hepatectomy, compared to intrathecal morphine (ITM).DesignProspective, randomized controlled trial.SettingA single tertiary care center from October 2019 and September 2020.PatientsA total of 60 donors scheduled to undergo elective laparoscopic right hepatectomy.InterventionsSixty donors were randomized to receive either bilateral continuous T8 ESP blocks with a programmed intermittent bolus regimen of 10 mL 0.2% ropivacaine every 3 h for 48 h (n = 30) or 400 μg ITM (n = 30), in addition to IV fentanyl PCA and multimodal analgesia.MeasurementsThe primary outcome was cumulative opioid consumption over the first 48 h, expressed as IV morphine equivalents. Secondary outcomes included pain scores, Quality of Recovery-15 scores, ambulation within 24 h, time to first flatus, and opioid-related adverse drug events over 72 h.Main resultsFifty-nine donors were analyzed. Cumulative 48-h opioid consumption was similar between the ITM and ESP groups (29.8 ± 18.2 vs. 35.1 ± 21.9 mg, mean difference (ESP-ITM) (95% CI), 5.3 (−11.5 to 22) mg; p > 0.99). Resting pain scores at 48 and 72 h postoperatively were significantly lower in the ESP group (0 [0–2] vs. 3 [1.5–3], and 0 [0–2] vs. 3 [1–3] respectively, both p<0.001) (Goldaracena and Barbas, 2019; Ko et al., 2009; Choi et al., 2007 [[1], [2], [3]]) respectively, both p < 0.001). The ESP group had significantly lower incidences of postoperative nausea, vomiting, and pruritus at all timepoints. There were no differences in recovery outcomes.ConclusionsContinuous ESP blocks did not reduce cumulative 48-h opioid consumption compared to 400 μg ITM after laparoscopic donor hepatectomy, but it was associated with a significantly reduced risk of postoperative nausea, vomiting and pruritus.Clinical trial number and registry URLClinical Trial Registry of Korea; https://cris.nih.go.kr/cris/index.jsp and identifier: KCT0004313; date of registration: October 15, 2019; principal investigator's name: Justin Sangwook Ko.     

The impact of social media presence,age, and patient reported wait times on physician review websites for sports medicine surgeons

BackgroundWhen choosing physicians, patients often review options online via physician review websites, which may influence decisions on providers.PurposeThe purpose of this study is to investigate the impacts of social media usage, age, and patient reported wait times on online ratings for three popular review websites.Study designCross-sectional study.MethodsThe American Orthopaedic Society for Sports Medicine database was used to extract demographic information for all listed sports medicine surgeons in Florida. Overall ratings, number of ratings and comments, and patient reported wait-times were recorded from three leading review websites (Healthgrades.com, Vitals.com, Google.com). Professionally focused SM accounts were searched for each physician on Facebook.com, Twitter.com, Instagram, and LinkedIn.com.Results102 orthopaedic sports medicine surgeons were included. At least one form of social media was used by 62.4% of our cohort. Those with social media had higher overall online physician ratings out of 5.00 across all review websites (Google:4.65vs4.44, p = 0.05; Healthgrades:4.41vs4.15, p = 0.03; Vitals:4.43vs4.14, p = 0.01). In bivariate analysis, older age was associated with lower ratings on Health Grades (Absolute difference (AD) −0.26, p < 0.0001), and social media was linked to higher ratings (Google: AD 0.21, p = 0.05; Healthgrades: AD 0.26, p = 0.03; Vitals: AD 0.29, p = 0.008). Longer wait times were associated with lower ratings in a dose-dependent manner in both bivariate and multivariable analysis.ConclusionsSocial media use among sports medicine surgeons correlated with higher overall physician ratings. Potentially, younger surgeons increase social media use because of a heightened concern for online image, whereas older surgeons may have less value in using online platforms to capitalize on an online presence. Older age and increased patient reported wait times in office had a negative correlation with online reviews, which highlights that factors beyond the surgeon's skill sets can influence overall ratings.     

Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial

Study objectiveTo investigate whether optimizing individualized goal-directed therapy (GDT) based on cerebral oxygen balance in high-risk surgical patients would reduce postoperative morbidity.DesignThis was a prospective, randomized, controlled study.SettingThe study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018.Patients146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled.InterventionPatients were randomized to an individualized GDT group or usual care group. Individualized GDT was targeted to achieve the following goals: A less than 20% decline in the regional cerebral oxygen saturation (rScO₂) level from baseline; a less than 20% decline in the mean arterial pressure (MAP) from baseline, as well as a bispectral index (BIS) of 45–60 before and after CPB and 40–45 during CPB.MeasurementsThe primary outcome was a composite endpoint of 30-day mortality and major postoperative complications.Main results128 completed the trial and were included in the modified intention-to-treat analysis. Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50–1.08; P = 0.15). Secondary analysis showed that 75 (59%) of 128 patients achieved individual targets (irrespective of intervention) and sustained less morbidity (relative risk 3.41, 95% CI 2.19–5.31; P < 0.001).ConclusionsIn high-risk patients undergoing cardiac surgery, individualized GDT therapy did not yield better outcomes, however, the achievement of preoperative individual targets may be associated with less morbidity.Trial registrationClinicaltrials.gov identifier: NCT03103633. Registered on 1 April 2017.     

Single shot of intravenous iron in cardiac surgery: The ICARUS study

BackgroundIron deficiency (ID), with or without anemia, is commonly observed among patients scheduled for cardiac surgery. We investigated if screening ID in the immediate preoperative period and treating ID patients regardless of anemia could reduce perioperative transfusion requirements.MethodsThis is an observational single-center propensity score-matched study including candidates to elective cardiac surgery prospectively and retrospectively enrolled. Prospectively enrolled patients were screened for ID at hospital admission: if ferritin was ≤100 μg/L or ≤ 300 μg/L with transferrin saturation index ≤20% they received intravenous ferric carboxymaltose, B12-vitamin, and folic acid. A retrospective series of patients not screened for ID and matched for gender, type of surgery, BMI, Goudie transfusion risk score, hemoglobin level, and red blood cell (RBC) indices, served as controls. The primary outcome was the proportion of patients requiring ≤1 packed RBC (pRBC) unit within day 7 or discharge The main secondary outcomes were intraoperative and postoperative pRBC transfusions, duration of hospitalization, and cost-effectiveness of ID screening and treatment.ResultsWe included 479 prospective and 833 retrospective cases: 442 patients screened for ID and 442 matched controls with unknown iron status were analyzed. ID was observed in 196 patients (44.3%) and iron was administered 1 day (IQR 1–2) before surgery. Overall, 76.9% of patients in the prospective group and 69.7% of controls received ≤1 pRBC transfusion (p = 0.014). The risk for multiple transfusions was lower in patients screened for ID (OR 0.689, 95% CI 0.510–0.930). Despite similar Hb levels at day 7, patients in the prospective group received fewer postoperative pRBC transfusions (p < 0.001) and had a shorter hospital length of stay (p < 0.001). Globally, hospitalization costs were lower in patients screened and treated for ID.ConclusionsShort-term pre-operative iron therapy is associated with a reduction in postoperative transfusions in anemic and non-anemic ID cardiac surgery patients and has a favorable impact on hospitalization costs.Clinical trial registrationNCT04744181     

Transcutaneous carbon dioxide levels and oxygen saturation following caesarean section performed under spinal anaesthesia with intrathecal opioids

BackgroundIntrathecal opioids can be associated with respiratory depression which may have serious consequences. We describe the use of a non-invasive monitor (TOSCA) to measure transcutaneous carbon dioxide levels and percentage of haemoglobin oxygen saturation in post-caesarean section patients in two hospitals which used different intrathecal opioids.MethodsEighty-nine women undergoing caesarean section were monitored postoperatively until 08.00 h on the first postoperative day. In addition to hyperbaric bupivacaine, patients from Hospital 1 received intrathecal diamorphine 300 μg: those from Hospital 2 received intrathecal fentanyl 15 μg and postoperative intramuscular morphine 10 mg and were given morphine patient-controlled analgesia. Data from TOSCA were analysed the following day. Respiratory depression was defined as oxygen saturations <90% or transcutaneous carbon dioxide levels >7 kPa for >2 min or the need for medical intervention for clinical respiratory depression.ResultsSustained hypercapnia was recorded in 8/45 (17.8%) patients from Hospital 1 and 3/44 (6.8%) from Hospital 2. Sustained oxygen saturations <90% were recorded in one patient from Hospital 2 and none from Hospital 1. The overall incidence of respiratory depression was 17.8% in Hospital 1 and 9.1% in Hospital 2. The median duration of hypercapnia was 9 min [IQR 5.8–12.4] in Hospital 1 and 11.5 min [IQR 7–32.8] in Hospital 2. No patient required medical intervention.ConclusionsThe incidence of opioid-induced respiratory depression detected by TOSCA is higher than previously reported by other monitoring methods. TOSCA may have a role in detecting subclinical respiratory depression in the obstetric population. Further studies with a control population are needed.