Ultrasound-Guided Modified Thoracolumbar Fascial Plane Block in Tianji Robot-Assisted Lumbar Internal Fixation: A Prospective, Randomized, and Non-Inferiority Study

Abstract

Li Hu,1,2,* Zhuoer Shen,3,* Daqing Pei,1,2 Jintao Sun,4 Bin Zhang,1 Zhipeng Zhu,1 Weiwei Yan,1 Hongmei Zhou,1– 3 Erdan An1,2 1Department of Anesthesiology, The Second Affiliated Hospital of Jiaxing University, Jiaxing City, People’s Republic of China; 2Key Laboratory of Basic Research and Clinical Transformation of Perioperative Precision Anesthesia, Jiaxing City, People’s Republic of China; 3Department of Anesthesiology, Bengbu Medical College, Bengbu City, People’s Republic of China; 4Jiaxing University Master Degree Cultivation Base, Zhejiang Chinese Medical University, Hangzhou City, People’s Republic of China*These authors contributed equally to this workCorrespondence: Hongmei Zhou; Erdan An, Department of Anesthesiology, The Second Affiliated Hospital of Jiaxing University, Huancheng Strasse 1518, Jiaxing, 314000, People’s Republic of China, Tel [phone], Fax [phone], Email [email protected]; [email protected]: Ultrasound-guided modified thoracolumbar fascial plane block (MTLIP) has been reported effective for postoperative pain control following lumbar surgery. Although trauma of the Tianji robot-assisted lumbar internal fixation is reduced, the degree of pain cannot be ignored.MTLIP may improve operation efficiency and reduce puncture complications.This study aimed to explore whether MTLIP is not inferior to thoracolumbar fascial plane block (TLIP) in the treatment of lumbar internal fixation.Methods: This prospective double-blinded, non-inferiority randomized trial enrolled patients underwent Tianji robot-assisted lumbar internal fixation between April and August 2022 to either MTLIP or TLIP. The primary outcome was an effective dermatomal block area after 30 min. Secondary outcomes included the numeric rating scale (NRS) scores, nerve block operation time, puncture times, image clarity, patient satisfaction, intraoperative opioid consumption, complications/adverse reactions, and Oswestry Disability Index (ODI).Results: Sixty participants were randomized to MTLIP (n=30) and TLIP (n=30). The effective dermatomal block area 30 min after block was non-inferior in the MTLIP group (283.6 ± 62.6 cm2) compared with the TLIP group (261.4± 53.2 cm2) (P=0.145; estimated mean difference: − 22.17, 95% CI: − 52.19, 7.85; smaller than the non-inferiority margin of 39.5). Compared with TLIP, MTLIP showed shorter operation time, smaller puncture times, and better target definition and satisfaction scores (all P 0.05).Conclusion: This non-inferiority trial supports the hypothesis that MTLIP yields a non-inferior effective dermatomal block area compared with TLIP for Tianji robot-assisted lumbar internal fixation.Clinical Trials Registration: Chinese Clinical Trial Registry (ChiCTR2200058687);.Keywords: local anesthetics, regional anesthesia, lumbosacral plexus, lumbar internal fixation, robotic surgical procedures

Keywords

• local anesthetics
• regional anesthesia
• aumbosacral plexus
• lumbar internal fixation
• robotic surgical procedures.