{"title":"腹腔镜根治性肾切除术术后镇痛的锯下肌前平面阻滞vs胸椎旁阻滞:一项随机对照、双盲、非劣效性临床试验方案","authors":"Jianghuai Lin, Huanghui Wu, Zhibin Wen, Yangyi Li, Changcheng Jiang, Binghong Lin, Yu Gu","doi":"10.2147/JPR.S506226","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Thoracic paravertebral nerve block (TPVB) is a widely used regional anesthesia technique employed in opioid-sparing anesthesia for abdominal surgery. Although the subserratus anterior plane block (SSAPB) has shown effectiveness in providing analgesia in upper abdominal surgery, it remains unclear whether the SSAPB offers comparable analgesic effects to the TPVB for retroperitoneal laparoscopic nephrectomy.</p><p><strong>Methods and analysis: </strong>This study is designed as a prospective, randomized controlled, double-blind, single-center, non-inferiority trial involving a total of 106 patients undergoing retroperitoneal laparoscopic nephrectomy. Participants will be randomly assigned to either the SSAPB group or the TPVB group in a 1:1 ratio. Both ultrasound-guided SSAPB and TPVB will involve the administration of 0.375% ropivacaine at a dose of 0.4 mL/kg prior to anesthesia induction. Subsequently, opioid-sparing anesthesia will be utilized during surgery. Each patient will receive standardized patient-controlled intravenous analgesia (PCIA) without a background infusion. The primary outcome measure will be the 24-hour postoperative consumption of rescue opioids. Secondary outcomes will include pain visual analogue scale (VAS) scores at various predefined time points within 48 hours post-surgery, analgesic consumption during and after surgery, time to first administration of rescue analgesics, incidence of perioperative cardiopulmonary adverse events, assessment of block characteristics, quality of recovery, time to ambulation and initiation of an oral diet, and length of stay in both the postoperative anesthesia care unit (PACU) and the hospital. Additionally, levels of inflammatory markers, including interleukin-6 (IL-6) and C-reactive protein (CRP), will be assessed at predefined time points.</p><p><strong>Discussion: </strong>This protocol outlines the first prospective, randomized controlled, double-blinded, non-inferiority clinical trial comparing perioperative analgesic efficacy and safety of SSAPB versus TPVB in patients undergoing retroperitoneal laparoscopic nephrectomy under opioid-sparing anesthesia. The study is designed to generate preliminary insights into optimizing regional anesthesia strategies for perioperative pain management in this surgical cohort.</p>","PeriodicalId":16661,"journal":{"name":"Journal of Pain Research","volume":"18 ","pages":"1615-1625"},"PeriodicalIF":2.5000,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954469/pdf/","citationCount":"0","resultStr":"{\"title\":\"Subserratus Anterior Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Laparoscopic Radical Nephrectomy: Protocol for a Randomized Controlled, Double-Blind, Non-Inferiority Clinical Trial.\",\"authors\":\"Jianghuai Lin, Huanghui Wu, Zhibin Wen, Yangyi Li, Changcheng Jiang, Binghong Lin, Yu Gu\",\"doi\":\"10.2147/JPR.S506226\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Thoracic paravertebral nerve block (TPVB) is a widely used regional anesthesia technique employed in opioid-sparing anesthesia for abdominal surgery. Although the subserratus anterior plane block (SSAPB) has shown effectiveness in providing analgesia in upper abdominal surgery, it remains unclear whether the SSAPB offers comparable analgesic effects to the TPVB for retroperitoneal laparoscopic nephrectomy.</p><p><strong>Methods and analysis: </strong>This study is designed as a prospective, randomized controlled, double-blind, single-center, non-inferiority trial involving a total of 106 patients undergoing retroperitoneal laparoscopic nephrectomy. Participants will be randomly assigned to either the SSAPB group or the TPVB group in a 1:1 ratio. Both ultrasound-guided SSAPB and TPVB will involve the administration of 0.375% ropivacaine at a dose of 0.4 mL/kg prior to anesthesia induction. Subsequently, opioid-sparing anesthesia will be utilized during surgery. Each patient will receive standardized patient-controlled intravenous analgesia (PCIA) without a background infusion. The primary outcome measure will be the 24-hour postoperative consumption of rescue opioids. Secondary outcomes will include pain visual analogue scale (VAS) scores at various predefined time points within 48 hours post-surgery, analgesic consumption during and after surgery, time to first administration of rescue analgesics, incidence of perioperative cardiopulmonary adverse events, assessment of block characteristics, quality of recovery, time to ambulation and initiation of an oral diet, and length of stay in both the postoperative anesthesia care unit (PACU) and the hospital. Additionally, levels of inflammatory markers, including interleukin-6 (IL-6) and C-reactive protein (CRP), will be assessed at predefined time points.</p><p><strong>Discussion: </strong>This protocol outlines the first prospective, randomized controlled, double-blinded, non-inferiority clinical trial comparing perioperative analgesic efficacy and safety of SSAPB versus TPVB in patients undergoing retroperitoneal laparoscopic nephrectomy under opioid-sparing anesthesia. The study is designed to generate preliminary insights into optimizing regional anesthesia strategies for perioperative pain management in this surgical cohort.</p>\",\"PeriodicalId\":16661,\"journal\":{\"name\":\"Journal of Pain Research\",\"volume\":\"18 \",\"pages\":\"1615-1625\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2025-03-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954469/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Pain Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/JPR.S506226\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pain Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/JPR.S506226","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Subserratus Anterior Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Laparoscopic Radical Nephrectomy: Protocol for a Randomized Controlled, Double-Blind, Non-Inferiority Clinical Trial.
Introduction: Thoracic paravertebral nerve block (TPVB) is a widely used regional anesthesia technique employed in opioid-sparing anesthesia for abdominal surgery. Although the subserratus anterior plane block (SSAPB) has shown effectiveness in providing analgesia in upper abdominal surgery, it remains unclear whether the SSAPB offers comparable analgesic effects to the TPVB for retroperitoneal laparoscopic nephrectomy.
Methods and analysis: This study is designed as a prospective, randomized controlled, double-blind, single-center, non-inferiority trial involving a total of 106 patients undergoing retroperitoneal laparoscopic nephrectomy. Participants will be randomly assigned to either the SSAPB group or the TPVB group in a 1:1 ratio. Both ultrasound-guided SSAPB and TPVB will involve the administration of 0.375% ropivacaine at a dose of 0.4 mL/kg prior to anesthesia induction. Subsequently, opioid-sparing anesthesia will be utilized during surgery. Each patient will receive standardized patient-controlled intravenous analgesia (PCIA) without a background infusion. The primary outcome measure will be the 24-hour postoperative consumption of rescue opioids. Secondary outcomes will include pain visual analogue scale (VAS) scores at various predefined time points within 48 hours post-surgery, analgesic consumption during and after surgery, time to first administration of rescue analgesics, incidence of perioperative cardiopulmonary adverse events, assessment of block characteristics, quality of recovery, time to ambulation and initiation of an oral diet, and length of stay in both the postoperative anesthesia care unit (PACU) and the hospital. Additionally, levels of inflammatory markers, including interleukin-6 (IL-6) and C-reactive protein (CRP), will be assessed at predefined time points.
Discussion: This protocol outlines the first prospective, randomized controlled, double-blinded, non-inferiority clinical trial comparing perioperative analgesic efficacy and safety of SSAPB versus TPVB in patients undergoing retroperitoneal laparoscopic nephrectomy under opioid-sparing anesthesia. The study is designed to generate preliminary insights into optimizing regional anesthesia strategies for perioperative pain management in this surgical cohort.
期刊介绍:
Journal of Pain Research is an international, peer-reviewed, open access journal that welcomes laboratory and clinical findings in the fields of pain research and the prevention and management of pain. Original research, reviews, symposium reports, hypothesis formation and commentaries are all considered for publication. Additionally, the journal now welcomes the submission of pain-policy-related editorials and commentaries, particularly in regard to ethical, regulatory, forensic, and other legal issues in pain medicine, and to the education of pain practitioners and researchers.