AUTHOR=Liao Dawei , Peng Ke , Zhang Yang , Liu Huayue , Xia Zhongyuan , Guo Jian , Wei Fujiang , Chen Chen , Lv Xin , Tong Jianhua , Li Xiaoshuang , Qu Xianfeng , Wang Xiaobin , Wang Yingbin , Ou Shanshan , Liu Hong , Shan Xisheng , Ji Fuhai 

TITLE=Effect of liposomal bupivacaine for preoperative erector spinae plane block on postoperative pain following video-assisted thoracoscopic lung surgery: a protocol for a multicenter, randomized, double-blind, clinical trial

JOURNAL=Frontiers in Medicine

VOLUME=Volume 11 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1359878

DOI=10.3389/fmed.2024.1359878

ISSN=2296-858X

ABSTRACT=Background: There is still a controversy about the superiority of liposomal bupivacaine (LB) over traditional local anesthetics in postoperative analgesia after thoracic surgery. This study aims to determine the effect of LB versus bupivacaine hydrochloride (HCl) for preoperative ultrasound-guided erector spinae plane block (ESPB) on postoperative acute and chronic pain in patients undergoing video-assisted thoracoscopic lung surgery.Methods: This multicenter, randomized, double-blind, controlled trial will include 272 adult patients scheduled for elective video-assisted thoracoscopic lung surgery. Patients will be randomly assigned, 1:1 and stratified by site, to a LB group (liposomal bupivacaine) or a BUPI group (bupivacaine HCl). All patients will receive ultrasoundguided ESPB with either LB or bupivacaine HCl prior to surgery and patient-controlled intravenous analgesia (PCIA) as rescue analgesia after surgery. Numeric rating scale (NRS) score will be assessed after surgery. The primary outcome is the area under the curve of pain scores at rest for 0-72 hours postoperatively. The secondary outcomes include total amount of opioid rescue analgesics through 0-72 hours postoperatively, time to first press on the PCIA device as rescue analgesia, the area under the curve of pain scores on activity for 0-72 hours postoperatively, NRS scores at rest and on activity at different time points during the 0-72 hours postoperative period, Quality of Recovery 15 scores at 72 hours after surgery, NRS scores on activity on postsurgical day 14, and postsurgical 3 months. Adverse events after the surgery are followed up to the postsurgical day 7, including postoperative nausea and vomiting, fever, constipation, dizziness, headache, insomnia, itching, prolonged chest tube leakage, new-onset atrial fibrillation, severe ventricular arrhythmia, deep venous thrombosis, pulmonary embolism, pulmonary atelectasis, cardiac arrest, ileus, urinary retention, chylothorax, pneumothorax, and organ failure. Analyses will be performed according to the intention to treat principle and secondarily with the per-protocol analysis.Discussion: We hypothesize that LB for preoperative ultrasound-guided ESPB would be more effective than bupivacaine HCl in reducing postoperative pain in video-assisted thoracoscopic lung surgery. Our results will contribute to the optimization of postoperative analgesia regimens for patients undergoing video-assisted thoracoscopic lung surgery.Clinical trial registration: http://www.chictr.org.cn, identifier: ChiCTR2300074852.