Ultrasound-Guided Bilateral Sequential Thoracic Paravertebral Block for Simultaneous Bilateral Uniportal Video-Assisted Thoracoscopic Surgery: Study Protocol for a Randomized Controlled Trial

Abstract

Purpose

Simultaneous bilateral pulmonary resection via uniportal video-assisted thoracoscopic surgery (UVATS) was safe and feasible for the treatment of bilateral multiple pulmonary nodules. But, it should be noted that considerable postoperative pain at the bilateral surgical site was a crucial issue. The safety and efficacy of bilateral thoracic paravertebral block (TPVB) have been reported for postoperative analgesia. But, whether bilateral sequential TPVB can be safely and effectively used in simultaneous bilateral UVATS remains unknown. Therefore, this study aimed to determine the analgesic efficacy and safety of bilateral sequential TPVB after simultaneous bilateral UVATS.

Study Design and Methods

In this study, 80 participants scheduled for UVATS will be randomly allocated to the bilateral sequential TPVB group (G₂) and the control group (G₁). The patient of G₂ will be performed bilateral TPVB at 2 time-points: before the start of the first side of pulmonary resection and before the start of the contralateral pulmonary resection. G₁ will only receive standard analgesia protocol. The primary outcome is the numeric rating scale score during coughing at 24 h postoperatively. The secondary outcomes include the Prince Henry Pain Score scores, sufentanil consumption, postoperative nausea and vomiting, levels of inflammatory factors, and the Quality of Recovery-40 scores at different time points, as well as chronic pain at postoperative day (POD) 90.

Discussion

This is the first prospective trial to determine the safety and effectiveness of ultrasound-guided bilateral sequential TPVB for postoperative analgesia following simultaneous bilateral UVATS. This study also intended to evaluate the effect of this intervention on postoperative quality of recovery and inflammation levels. The final results will provide clinical evidence related to bilateral sequential TPVB, and promote the application of that acting as a more appropriate analgesic method for simultaneous bilateral UVATS.

Keywords:

• thoracic surgery
• video-assisted
• multiple pulmonary nodules
• nerve block
• pain measurement

Trial Status

This trial was approved by the Clinical Research Ethics Committee of Shanghai Pulmonary Hospital (approval No. 2022LY0725). And, the study protocol was registered at the Chinese Clinical Trial Registry on November 8, 2022 (identifier: ChiCTR2200065541). The first participant was recruited on 10 November 2022, and the patient recruitment is expected to be finished by 1 November 2024.

Acknowledgments

The authors acknowledge all the patients for participation in this project at Shanghai Pulmonary Hospital, Tongji University School of Medicine.

Author Contributions

All authors made a significant contribution to this work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. Yugang Lu, Qing Zhou, and Yu Fu contributed equally to this work.

Disclosure

The authors report no conflicts of interest related to this work.

Additional information

Funding

This work was supported by grants from the following: National Natural Science Foundation of China (82170107), Shanghai Municipal Health Commission (202140406), Excellent Subject Leader Program of Shanghai Municipal Health Commission (2022XD007), and Development Fund of Department of Anesthesiology, Shanghai Pulmonary Hospital, Tongji University School of Medicine 2022.