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

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

doi:10.3389/fmed.2024.1359878

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

Front Med (Lausanne). 2024 Apr 12:11:1359878. doi: 10.3389/fmed.2024.1359878. eCollection 2024.

Authors

Dawei Liao^#^{1

2

3}, Ke Peng^#^{1

2}, Yang Zhang^#^{1

2}, Huayue Liu^{1

2}, Zhongyuan Xia⁴, Jian Guo⁵, Fujiang Wei⁶, Chen Chen⁷, Xin Lv⁸, Jianhua Tong⁹, Xiaoshuang Li¹⁰, Xianfeng Qu¹¹, Xiaobin Wang¹², Yingbin Wang¹³, Shanshan Ou¹⁴, Hong Liu¹⁵, Xisheng Shan^{1

2}, Fuhai Ji^{1

2}

Affiliations

¹ Department of Anesthesiology, The First Affiliated Hospital of Soochow University, Suzhou, China.
² Institute of Anesthesiology, Soochow University, Suzhou, China.
³ Department of Anesthesiology, Tongren People's Hospital, Tongren, China.
⁴ Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, China.
⁵ Department of Anesthesiology, The Fourth Affiliated Hospital Zhejiang University School of Medicine, Yiwu, China.
⁶ Department of Anesthesiology, Yantaishan Hospital, Yantai, China.
⁷ Department of Anesthesiology, The First People's Hospital of Changzhou, Changzhou, China.
⁸ Department of Anesthesiology, Shanghai Pulmonary Hospital, Shanghai, China.
⁹ Department of Anesthesiology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
¹⁰ Department of Anesthesiology, Lianshui County People's Hospital, Huaian, China.
¹¹ Department of Anesthesiology, Taizhou Municipal Hospital, Taizhou, China.
¹² Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
¹³ Department of Anesthesiology, Lanzhou University Second Hospital, Lanzhou, China.
¹⁴ Department of Anesthesiology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.
¹⁵ Department of Anesthesiology and Pain Medicine, University of California Davis Health, Sacramento, CA, United States.

^# Contributed equally.

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 the liposomal bupivacaine (LB) group or the bupivacaine (BUPI) HCl group. All patients will receive ultrasound-guided ESPB with either LB or bupivacaine HCl before surgery and patient-controlled intravenous analgesia (PCIA) as rescue analgesia after surgery. The 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 h postoperatively. The secondary outcomes include the total amount of opioid rescue analgesics through 0-72 h postoperatively, time to the first press on the PCIA device as rescue analgesia, the area under the curve of pain scores on activity for 0-72 h postoperatively, NRS scores at rest and on activity at different time points during the 0-72 h postoperative period, Quality of Recovery 15 scores at 72 h after surgery, and 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. Analyzes will be performed first according to the intention to treat principle and second 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.

Keywords: area under the curve; erector spinae plane block; liposomal bupivacaine; postoperative pain; thoracoscopic.

Grants and funding

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. Research support was provided by the institutional and departmental sources at the First Affiliated Hospital of Soochow University and funding support was provided by the Jiangsu Province Medical Research Key Project (ZD2022021) and Suzhou Medical Innovation Applied Research (SKY2022138).