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.

Resting Hemodynamics and Response to Exercise Using the 6-Minute Walk Test in Late Pregnancy: An International Prospective Multicentre Study.

BACKGROUND: Cardiac disease is the leading cause of maternal death. Assessment of cardiovascular fitness is important in pregnant women because it is linked to increased risk of cardiac disease but is rarely undertaken or studied. The 6-Minute Walk Test (6MWT) is a safe exercise test but is not used in pregnancy. We determined the 95% reference interval for resting heart rate (HR) and distance walked for the 6MWT, as well as hemodynamic recovery variables, and quantified expectations and actual experiences of exertion and breathlessness with exercise in late pregnancy. METHODS: After institutional research board approval (Australian and New Zealand Clinical Trials Registry Number: 12615000964516), 300 healthy term nulliparous pregnant women performed the 6MWT at 3 tertiary referral obstetric hospitals using a standardized protocol. Each woman underwent two 6MWT with maximum 15-minute recovery period after each test. Hemodynamic variables were measured at rest and after exercise. Participants were asked 4 questions, 2 regarding expectation and 2 regarding actual experience, using the Rating of Perceived Exertion scale and Modified Borg Dyspnea scale. RESULTS: Participant characteristics and resting variables were mean (standard deviation [SD]); age, 31 years (4.2 years); body mass index, 27 kg/m (2.9 kg/m); gestational age, 37 weeks (1.3 weeks); HR, 85 bpm (10.8 bpm) with 95% reference interval 64-106 bpm; systolic blood pressure, 112 mm Hg (10.2 mm Hg); diastolic blood pressure, 72 mm Hg (8.6 mm Hg); oxygen saturation, 98% (0.9%); and respiratory rate, 18 breaths/min (5.7 breaths/min). The mean (SD) average distance walked was 488 m (94.9 m) with a speed of 3.0 mph (0.64 mph) with a 95% reference interval of 302-674 m. The mean (SD) HR increase with exercise was 12 bpm (11.0 bpm) with a median [quartile] recovery time of 5.0 minutes [1-8 minutes]. A lower resting HR was associated with increased distance walked (r = -0.207; 95% confidence interval, -0.313 to -0.096; P < .001). A greater HR change with exercise was associated with increased recovery time from exercise (r = 0.736; 95% confidence interval, 0.697-0.784; P < .001). Sixty-three percent and 83% of participants, respectively, expected to be more exerted and breathless than they actually were with exercise. CONCLUSIONS: The 6MWT is feasible and applicable in term pregnant women. The reference intervals for resting HR and distance walked in the 6MWT have been generated. HR increases by approximately 12 bpm with submaximal exercise, and half of the women recovered within 5 minutes of submaximal exercise. Women expected to be more exerted and breathless than they actually were with exercise.