A pilot randomized-controlled trial evaluating the erector spinae plane block in thoracic and breast surgery.

PURPOSE: This pilot study evaluated the feasibility of investigating the effect of the erector spinae plane (ESP) block on the patient-centred outcomes of quality of recovery-15 (QoR-15), and brief pain inventory (BPI) in thoracic and breast surgery patients. METHODS: In this randomized-controlled pilot trial, 82 patients undergoing video-assisted thoracoscopic surgery (n = 77) and mastectomy (n = 5) received either continuous ESP block with ropivacaine (ropivacaine group) or the same procedure with 0.9% saline (saline group). All patients received surgical intercostal block (thoracic surgery) or local anesthetic infiltration (breast surgery). Feasibility as the primary outcome was evaluated on recruitment (three patients per week), catheter retention (above 90% at 24 hr), and patient attrition (less than 10%). Secondary outcomes comprised of QoR-15, BPI, and opioid consumption. RESULTS: Recruitment rate was 1.8 patients per week. Catheters were retained in 77 patients (94%) at 24 hr. At three months, five patients were lost to follow-up (6%). At 24 hr compared with baseline, the ropivacaine group had a smaller decline in QoR-15 score (median difference, 14; 95% confidence interval [CI], 2 to 26; P = 0.02) and a smaller increase in BPI global score (median difference, 14; 95% CI, 0 to 24; P = 0.048). There was no difference in opioid consumption (P = 0.08). CONCLUSIONS: In this pilot study, the target recruitment rate was not met, but catheter retention and patient attrition rates were both satisfactory. A definitive trial with QoR-15 as the primary outcome would require 300 study participants. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ID12618000701224); registered 30 April 2018.

RéSUMé: OBJECTIF: Cette étude pilote a évalué la faisabilité d'explorer l'effet d'un bloc du plan des muscles érecteurs du rachis sur des résultats centrés sur le patient, soit la qualité de récupération (QoR-15) et le Questionnaire concis de la douleur (QCD ou BPI 'Brief Pain Inventory'), chez les patients de chirurgie thoracique et mammaire. MéTHODE: Dans cette étude pilote randomisée contrôlée, 82 patients subissant une chirurgie thoracoscopique (n = 77) ou une mastectomie (n = 5) ont reçu soit un bloc continu du plan des muscles érecteurs du rachis avec de la ropivacaïne (groupe ropivacaïne), ou la même intervention avec une solution saline à 0,9 % (groupe salin). Tous les patients ont reçu un bloc intercostal chirurgical (chirurgie thoracique) ou une infiltration d'anesthésique local (chirurgie mammaire). La faisabilité a été évaluée par les critères de recrutement (trois patients par semaine), de la rétention du cathéter (plus de 90 % à 24 h), et du taux d'attrition des patients (moins de 10 %). Les critères d'évaluation secondaires comportaient la QoR-15, le QCD et la consommation d'opioïdes. RéSULTATS: Le taux de recrutement était de 1,8 patients par semaine. Les cathéters sont restés en place chez 77 patients (94 %) à 24 h. À trois mois, cinq patients ont été perdus au suivi (6 %). Après 24 h, par rapport aux valeurs de base, le groupe ropivacaïne présentait un déclin plus léger du score de QoR-15 (différence médiane, 14; intervalle de confiance [IC] 95 %, 2 à 26; P = 0,02) ainsi qu'une augmentation moindre du score global de QCD (différence médiane, 14; IC 95 %, 0 à 24; P = 0,048). Aucune différence n'a été observée en matière de consommation d'opioïdes (P = 0,08). CONCLUSION: Dans cette étude pilote, le taux de recrutement cible n'a pas été atteint, mais les taux de rétention des cathéters et d'attrition des patients étaient tous deux satisfaisants. Une étude définitive de la QoR-15 en tant que critère d'évaluation principal nécessiterait le recrutement de 300 participants. ENREGISTREMENT DE L'éTUDE: Australian New Zealand Clinical Trials Registry (ID12618000701224); enregistrée le 30 avril 2018.

Weightbearing Cone-Beam Computed Tomography of Acute Ankle Syndesmosis Injuries.

Syndesmotic injuries are common, but only a subset of these injuries are unstable. A noninvasive tool for identifying instability would aid in the selection of patients for surgery. Weightbearing computed tomography (CT) data have been reported for healthy patients, but there are limited data on unstable syndesmoses. We evaluated the syndesmotic area of arthroscopically proven unstable ankles after acute injury. This is a prospective comparative study of consecutive patients recruited to a weightbearing CT database. Thirty-nine patients were included for analysis with arthroscopically proven unstable syndesmoses and an uninjured contralateral ankle. The syndesmosis area was measured for both ankles, in non-weightbearing and weightbearing positions, and compared. Syndesmosis area of the unstable ankle was significantly greater than the uninjured ankle of the same patient, by a mean of 22.9 ± 10.5 mm2. This was a significantly greater difference than that observed with non-weightbearing CT (9.8 ± 10.2 mm2, p < .001). Dynamic change in area, from non-weightbearing to weightbearing, of the unstable ankle (13.7% [16.6 ± 9.9 mm2]) was significantly greater than that of the uninjured ankle (3.1% [3.4 ± 6.7 mm2], p < .001). The intraobserver and interobserver correlations were good with intraclass correlation coefficients of 0.983 and 0.970, respectively. Weightbearing CT demonstrated significantly greater diastasis in unstable ankles than did conventional non-weightbearing CT. Syndesmosis area measurement was reliable and reproducible. Dynamic change in area and weightbearing comparison with the contralateral uninjured ankle are 2 parameters that may prove useful in the future for predicting syndesmotic instability.

Quality of Recovery After Breast Surgery: A Multicenter Randomized Clinical Trial Comparing Pectoral Nerves Interfascial Plane (Pectoral Nerves II) Block With Surgical Infiltration.

BACKGROUND: Pectoral nerves (PECS II) block is a popular regional analgesia technique for breast surgery. PECS II block or local infiltration by surgeon may improve outcomes including quality of recovery (QoR). METHODS: In this multicenter randomized clinical trial, 104 female patients undergoing breast surgery received: (1) PECS II block with local anesthetic and surgical infiltration with 0.9% saline (PECS group) or (2) PECS II block with 0.9% saline and surgical infiltration with local anesthetic (infiltration group). Patients, anesthetists, surgeons, nursing staff, and research assistants were blinded to group allocation. Patients received standardized general anesthesia and multimodal analgesia. The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional) QoR-15 questionnaire measured 24 hours postoperatively. Secondary outcomes were pain, and its functional interference measured 24 hours and 3 months postoperatively using the Brief Pain Inventory (BPI) short form (0, optimal; 120, worst possible). Randomly assigned groups were compared on outcomes using the Wilcoxon rank-sum test, and the results were reported as median difference with 95% confidence interval. RESULTS: One hundred eight patients were recruited from August 17, 2016 to June 8, 2018, and 4 patients were withdrawn. Twelve patients from 104 had mastectomy, with the remainder having less invasive surgery. Baseline QoR-15 global scores reported as median [quartiles] were 135 [129, 143] in the PECS group and 139 [127, 143] in the infiltration group. The 24-hour QoR-15 global score reported as median [quartiles] was 131 [116, 140] in the PECS group and 123 [117, 143] in the infiltration group (P = .60), with median difference (95% confidence interval) of -2 (-9 to 5). The median difference reported as infiltration minus PECS for QoR-15 domains was pain 0 (-2 to 1), physical comfort -1 (-3 to 2), physical independence 0 (-2 to 1), psychological support 0 (0-0), and emotions 0 (-1 to 2) (P > .28). The BPI pain subscale at 24 hours (0-40, lower score indicates less pain), reported as median [quartiles], was 7 [2, 13] in the PECS group and 10 [5, 17] in the infiltration group (P = .15). The BPI global score at 24 hours, reported as median [quartiles], was 20 [7, 36] in the PECS group and 23 [10, 43] in the infiltration group (P = .34) and at 3 months was 0 [0, 14] and 0 [0, 11] (P = .85). CONCLUSIONS: After mostly minor surgery for breast cancer, PECS II block was not superior to local infiltration by the surgeon.

Impact of Local Infiltration Analgesia on the Quality of Recovery After Anterior Total Hip Arthroplasty: A Randomized, Triple-Blind, Placebo-Controlled Trial.

BACKGROUND: Local infiltration analgesia (LIA) is commonly used in anterior total hip arthroplasty (THA) surgery; however, evidence for its efficacy is lacking. We hypothesized that LIA with 0.2% ropivacaine when compared with injection of placebo (0.9% saline) would improve patient quality of recovery on postoperative day (POD) 1, as measured by the Quality of Recovery-15 (QoR-15) score. METHODS: Patients scheduled to have a primary unilateral anterior THA with a single surgeon in a tertiary level metropolitan hospital were randomized to receive LIA with either 2.5 mL/kg of 0.2% ropivacaine or 0.9% saline as placebo. Patients and clinical and study personnel were blinded to group allocation. Perioperative care was standardized and this included spinal anesthesia and oral multimodal analgesia. The primary outcome was a multidimensional (pain, physical comfort, physical independence, emotions, and psychological support) patient-reported quality of recovery scale, QoR-15, measured on POD 1. RESULTS: One hundred sixty patients were randomized; 6 patients were withdrawn after randomization and 2 patients had incomplete outcome data. The intention-to-treat analysis included 152 patients. The median (interquartile range [IQR]) QoR-15 score on POD 1 of the ropivacaine group was 119.5 (102-124), compared with the placebo group which had a median (IQR) of 115 (98-126). The median difference of 2 (95% confidence interval [CI], -4 to 7; P = .56) was not statistically or clinically significant. An as-per-protocol sensitivity analysis of 146 patients who received spinal anesthesia without general anesthesia, and the allocated intervention, also showed no evidence of a significant difference between groups. Secondary outcomes (worst pain numerical rating scale at rest and with movement on POD 1, opioid consumption on PODs 1 and 2, mobilization on POD 1, Brief Pain Inventory severity and interference on POD 90, and length of stay) were similar in both groups. CONCLUSIONS: LIA with 0.2% ropivacaine when compared with 0.9% saline as placebo did not improve quality of recovery 1 day after anterior THA.

Acromioclavicular Joint Stabilization: A Biomechanical Study of Bidirectional Stability and Strength.

BACKGROUND: It is important to restore horizontal and vertical stability to the acromioclavicular (AC) joint when treating dislocations of this joint. Most surgical stabilization techniques of the AC joint have primarily addressed the coracoclavicular ligament complex; however, these techniques may not satisfactorily restore horizontal stability to the AC joint. PURPOSE: To evaluate the strength and bidirectional stability of 3 AC joint stabilizing techniques in a cadaveric model. STUDY DESIGN: Controlled laboratory study. METHODS: A total of 24 cadaveric shoulders were randomly allocated to 3 treatment groups. For each group, a standardized AC joint stabilizing procedure was performed, and the specimens were potted for mechanical testing. The following reconstruction techniques were used: a single clavicular tunnel for group A, a double clavicular tunnel for group B, and a double clavicular tunnel plus suture fixation across the AC joint for group C. The specimens underwent cyclic loading in the horizontal and vertical planes and then load to failure. Eight control specimens also underwent cyclic loading in both planes. Construct stiffness during cyclic loading, change in displacement after cyclic loading in both planes, load to failure in the vertical plane, and mode of failure were evaluated, and stiffness was compared among the treatment groups as well as with a control group. RESULTS: There was a decrease in joint stiffness for all groups, including controls, during the cyclic loading. Compared with controls, all 3 treatment groups demonstrated equivalent stiffness and displacement in the vertical plane. In the horizontal plane, all 3 treatment groups demonstrated decreased stiffness, increased displacement, or both when compared with controls. When groups were compared, no treatment arm proved superior regarding stiffness or displacement in either plane. Load-to-failure testing of the 3 treatment groups in the vertical plane demonstrated construct strength and stiffness comparable with reports for the native AC joint. The mode of failure was predominantly fracture at the point of fixation to the testing apparatus. CONCLUSION: There was no difference in bidirectional strength and stability between the single- and double-clavicular tunnel techniques of coracoclavicular reconstruction. The addition of a stabilizing suture across the AC joint does not improve horizontal stability in the absence of repair of the AC joint capsule and deltotrapezial fascia. CLINICAL RELEVANCE: This laboratory study provides further evidence of the importance of the AC joint capsule and associated soft tissues in affording horizontal stability to that joint. Information from this and subsequent studies utilizing a bidirectional model can influence the choice of surgical procedure in the clinical treatment of AC joint dislocations.

Minimizing Propionibacterium acnes contamination in shoulder arthroplasty: use of a wound protector.

BACKGROUND: Propionibacterium acnes may be transmitted from the subdermal tissues to the deeper tissues during shoulder arthroplasty surgery, resulting in deep infection. The aim of this prospective, clinical study was to determine whether the use of a wound protector drape can lower the incidence of P. acnes in the wound during shoulder arthroplasty surgery. METHODS: For a consecutive series of 47 patients undergoing shoulder arthroplasty, a wound protector drape was used during surgery, to isolate the subdermal layer from the surgeons' hands, retractors and other instruments. Microbiological swabs were taken both from the subdermal layer and the exposed drape to determine the incidence of P. acnes at both sites. RESULTS: The overall incidence of P. acnes in the subdermal layer was 23%. A fivefold decrease in the incidence of P. acnes in the exposed superficial layer was demonstrated by use of the wound protector drape. CONCLUSION: Use of a wound protector drape to isolate the superficial tissue layer from the surgeons' gloves, instruments and retractors decreases the incidence of P. acnes in the surgical field. This may result in a decreased rate of transmission to the deeper tissues, and a decreased rate of P. acnes deep infection.

Platelet transfusion is not associated with increased mortality or morbidity in patients undergoing cardiac surgery.

BACKGROUND: Transfusion of platelets is common in cardiac surgery, and while there are guidelines for their use, there are concerns about potential risks. We aimed to assess the impact of platelet transfusion on mortality, thrombosis, and infection in this patient group. STUDY DESIGN AND METHODS: A retrospective cohort study of all patients at St Vincent's Hospital Melbourne who underwent a first cardiac surgery procedure from June 2001 to June 2014 was conducted. A propensity-weighted analysis was performed to examine the association between intraoperative platelet transfusion and outcomes. RESULTS: A total of 5233 patients met inclusion criteria, and 531 (10.15%) received intraoperative platelet transfusion (median two platelet doses, interquartile range, 1-17). Patients receiving platelets were older, had higher body mass index, lower rates of diabetes and dyslipidemia, higher rates of infective endocarditis, recent myocardial infarction and unstable angina, and exposure to aspirin or clopidogrel. On univariable analysis, platelet transfusion was associated with increased 30-day mortality (2.4% vs. 10.55%, p < 0.001), return to theatre for bleeding (3.23% vs. 13.37%, p < 0.001), and rates of any infection (9.26% vs. 19.17%, p < 0.001). After adjusting for confounders, platelet transfusion was not associated with increased risk of 30-day mortality or infective complications. Platelet transfusion was associated with higher rates of return to theatre (relative risk [RR], 2.46; confidence interval [CI], 1.42, 4.04; p = 0.001) and decreased risk of thromboembolic events (RR, 0.28; CI, 0.15, 0.51; p < 0.001). CONCLUSION: Platelet transfusion was not associated with increased mortality or infective complications following first cardiac surgery. Further prospective studies are required to identify patients most likely to benefit from platelet transfusion.

Mortality is Greater in Septic Patients With Hyperlactatemia Than With Refractory Hypotension.

BACKGROUND: In septic patients, it is uncertain whether isolated hyperlactatemia (lactate ≥4 mmol/L without refractory hypotension) can be used to diagnose septic shock and whether mortality rate differs from that of isolated refractory hypotension (refractory to 1000 mL or greater fluid bolus). AIMS: To compare baseline characteristics, treatments, and outcomes of participants enrolled into the Australian Resuscitation in Sepsis Evaluation (ARISE) trial according to the presence of isolated hyperlactatemia or isolated refractory hypotension. PATIENTS: Cohort of 1,332 ARISE participants with sepsis and either isolated hyperlactatemia or isolated refractory hypotension. METHODS: We performed a secondary analysis of the ARISE data, constructing a propensity score model to discriminate between hyperlactatemia and isolated refractory hypotension. We analyzed 90-day all-cause mortality using a generalized linear model and inverse propensity score weighting. We modeled length of intensive care unit (ICU) and hospital stay using time to event analyses incorporating mortality as a competing risk. RESULTS: There were 478 participants (35.9%) with isolated hyperlactatemia and 854 (64.1%) with isolated refractory hypotension. They had similar median (interquartile range) ages (66.2 [54.2, 76.3] years vs. 65.2 [50.9, 75.5] years) and similar sources of infection. However, isolated hyperlactatemia participants had higher mean (standard deviation) baseline APACHE II scores (isolated hyperlactatemia 16.2 [6.4]) vs. 14.5 [6.4] for isolated refractory hypotension; P < 0.001). Isolated hyperlactatemia participants had a 1.7 times higher risk of 90-day mortality (propensity-weighted risk ratio; 95% confidence intervals [CI] 1.2, 2.5, P = 0.003). They were less likely to be discharged alive from ICU and hospital (propensity weighted sub-hazard ratio 0.77 (95% CI 0.64, 0.92; P < 0.005) and 0.79 (95% CI 0.66, 0.95; P = 0.01), respectively). CONCLUSIONS: ARISE trial participants with isolated hyperlactatemia had worse adjusted 90-day mortality than those with isolated refractory hypotension. In septic patients, isolated hyperlactatemia may define greater illness severity and worse outcomes than isolated refractory hypotension.

Transfusion interventions in critical bleeding requiring massive transfusion: a systematic review.

Critical bleeding (CB) requiring massive transfusion (MT) can occur in a variety of clinical contexts and is associated with substantial mortality and morbidity. In 2011, the Australian National Blood Authority (NBA) published patient blood management guidelines for CB and MT, which found limited high-quality evidence from which only 2 recommendations could be made. The aim of this systematic review (SR) was to update these guidelines and identify evidence gaps still to be addressed. A comprehensive search was performed for randomized controlled trials (RCTs) and SRs using MeSH index and free text terms in MEDLINE, the Cochrane Library (Issue 11, 2012), EMBASE, CINHAL, PUBMED, and the Transfusion Evidence Library up to July 15, 2014. The evidence was grouped according to 4 questions based on the original guideline relating to transfusion interventions: (1) effect of dose, timing, and ratio of red blood cells (RBCs) to component therapy on patient outcomes; (2) effect of RBC transfusion on patient outcomes; (3) effect of fresh frozen plasma, platelet, cryoprecipitate, fibrinogen concentrate, and prothrombin complex concentrate on patient outcomes; and (4) effect of recombinant activated factor VII (rFVIIa) on patient outcomes. From this search, 19 studies were identified: 6 RCTs and 13 SRs. Two of the RCTs were pilot/feasibility studies, 3 were investigating rFVIIa, and 1 compared restrictive versus liberal RBC transfusion in upper gastrointestinal hemorrhage. Overall, limited new evidence was identified and substantial evidence gaps remain, particularly with regard to the effect of component therapies, including ratio of RBC to component therapies, on patient outcomes. Clinical trials to address these questions are required.