Annals of medicine · 2025
Effect of erector spinae plane block on overall benefit of analgesia after esophagectomy: a randomized controlled trial protocol.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Chong Ying-Zi, Zhu Na-Na, Dou Wei, Chen Ke, Chen Shao-Mu, Sudhan Nazneen, Ji Fu-Hai, Peng Ke
Аннотация
INTRODUCTION: Management of postoperative pain following esophagectomy is challenging. This study aims to investigate the analgesic efficacy and overall clinical benefit of erector spinae plane block (ESPB) using either liposomal bupivacaine or ropivacaine in patients undergoing esophagectomy.
PATIENTS AND METHODS: This single-center, randomized, double-blind, placebo-controlled trial will be conducted at the First Affiliated Hospital of Soochow University. Eighty-four adult patients scheduled for transthoracic esophagectomy will be randomized (1:1:1) to receive a preoperative ultrasound-guided ESPB using either liposomal bupivacaine, ropivacaine, or normal saline placebo. All patients will receive standardized general anesthesia and postoperative patient-controlled intravenous analgesia with sufentanil. The primary outcome is the mean Overall Benefit of Analgesia Score (OBAS) over postoperative days 1 to 5, a multidimensional tool integrating pain, opioid-related side effects, and patient satisfaction. Secondary outcomes include the OBAS on each of the first 5 postoperative days, cumulative opioid consumption during postoperative 5 days, incidence of major in-hospital complications, length of postoperative hospital stay, and 5-year overall survival.
DISCUSSION: Utilizing the OBAS to comprehensively assess analgesic benefit, the findings of this trial will guide evidence-based refinement of multimodal analgesia for patients undergoing esophagectomy.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2500099481; registered on March 25, 2025).
PATIENTS AND METHODS: This single-center, randomized, double-blind, placebo-controlled trial will be conducted at the First Affiliated Hospital of Soochow University. Eighty-four adult patients scheduled for transthoracic esophagectomy will be randomized (1:1:1) to receive a preoperative ultrasound-guided ESPB using either liposomal bupivacaine, ropivacaine, or normal saline placebo. All patients will receive standardized general anesthesia and postoperative patient-controlled intravenous analgesia with sufentanil. The primary outcome is the mean Overall Benefit of Analgesia Score (OBAS) over postoperative days 1 to 5, a multidimensional tool integrating pain, opioid-related side effects, and patient satisfaction. Secondary outcomes include the OBAS on each of the first 5 postoperative days, cumulative opioid consumption during postoperative 5 days, incidence of major in-hospital complications, length of postoperative hospital stay, and 5-year overall survival.
DISCUSSION: Utilizing the OBAS to comprehensively assess analgesic benefit, the findings of this trial will guide evidence-based refinement of multimodal analgesia for patients undergoing esophagectomy.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2500099481; registered on March 25, 2025).
Предметные рубрики MeSH
HumansEsophagectomyPostoperative PainNerve BlockDouble-Blind MethodMaleParaspinal MusclesFemaleBupivacaineRopivacaineMiddle AgedAdultAnalgesics, OpioidAnalgesia, Patient-ControlledRandomized Controlled Trials as TopicAnesthetics, LocalPain MeasurementUltrasonography, InterventionalAgedPain ManagementTreatment OutcomePatient Satisfaction