Abstract: 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.
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Contributed Indexing: Keywords: Pilot study; erector spinae plane block; patient-centred outcomes; quality of recovery
Local Abstract: [Publisher, French] 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.
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