Esophageal cancer is the eighth most prevalent malignant tumor in the world and has the sixth highest mortality rate. Postoperative pulmonary complications (PPCs) are one of the most common complications of minimally invasive esophagectomy (MIE). The non-local anesthetic effects of lidocaine have been widely reported, but only a few studies have focused on its effects on lung protection in MIE. This study is designed to test the hypothesis that intraoperative intravenous lidocaine infusion can reduce the incidence of PPCs in patients undergoing MIE. In this double-center, randomized, double-blind, placebo-controlled superiority trial, 770 participants from three centers will be randomly assigned to two groups, namely the lidocaine group and the placebo group in a 1:1 ratio. The primary outcome is the incidence of PPCs within 7 days following surgery. The secondary outcomes include the incidence of (1) respiratory infection; (2) respiratory failure; (3) pneumothorax; (4) atelectasis; (5) pleural effusion; (6) bronchospasm; (7) aspiration pneumonitis; (8) anastomotic fistula; (9) moderate to severe pain within 24 and 48 h at rest and when coughing; (10) additional rescue analgesics use. This study aims to address a significant gap in the prevention of PPCs in patients undergoing MIE for esophageal cancer. PPCs are common and can negatively impact recovery and survival outcomes, making effective prevention strategies crucial. While lidocaine's non-local anesthetic properties, including anti-inflammatory and analgesic effects, have been well-documented, few studies have focused on its role in lung protection during MIE. By assessing the incidence of PPCs and other secondary outcomes, this trial seeks to determine whether intraoperative lidocaine infusion can offer a novel, non-invasive approach to reducing PPC risk and improving overall postoperative recovery. If lidocaine proves effective, this study will provide a new way to improve patient outcomes, particularly for those with high PPCs risk. Furthermore, the results could expand the scope of lidocaine use in surgical settings, suggesting a potentially low-cost and accessible intervention for broader perioperative lung protection. NCT06138041 (ClinicalTrials.gov, registration date: 2024-10-22). This study will provide a reliable conclusion investigating the effect of intraoperative intravenous lidocaine infusion on postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. The study includes an appropriate sample size and a double-center, randomized, and double-blind placebo-controlled design, which reduces potential bias. The full analysis set consists of all participants according to the intention-to-treat principle and the per-protocol set will be both performed. Per-protocol analysis will be used for sensitivity analyses. Intravenous lidocaine infusion is only continued until patients are transferred out of the post-anesthesia care unit, while the benefit of prolonged infusion in the ward will not be investigated.
To assess the effect of low-dose perioperatively continuous infusion of lidocaine on postoperative inflammation, immune function and quality of recovery in patients undergoing video-assisted thoracoscopic surgery (VATS). Patients with lung cancer aged 18-65 years, undergoing elective VATS were randomized into lidocaine intervention (L) and standard care (C) groups. For patients in Group L, 1 mg/kg lidocaine was intravenously injected within approximately 10 min during the induction of anesthesia, followed by a continuous infusion of lidocaine at a rate of 1.5 mg/kg/h until the patient left the operating room. The postoperative analgesia plan included 2% lidocaine at 5 mg/kg. Group C was given an equal volume of normal saline as a control.The primary outcomes were plasma concentrations of tumor necrosis factor-α (TNF-α), interleukin-1(IL-1), and interleukin-6 (IL-6), along with T lymphocyte counts of CD3, CD4, CD8, and the CD4/CD8 ratio before anesthesia induction (T1), and 24 h (T2) and 48 h (T3) postoperatively. Secondary outcomes included the visual analog scale (VAS) for pain at rest and during movement, Time to first post-operative rescue analgesia, Cumulative OME(the oral morphine equivalents) at 24 h, along with the frequency and severity of postoperative nausea and vomiting (PONV) within the initial 48-h after surgery. In Group C and Group L, compared with preoperative levels, the levels of CD3 + , CD4 + and the ratio of CD4 + /CD8 + were significantly decreased at 24 and 48 h postoperatively, while the levels of TNF-α, IL-1 and IL-6 were significantly increased (P < 0.05). Compared with Group C, in Group L, the levels of CD3 + , CD4 + and the ratio of CD4 + /CD8 + were significantly increased at 24 and 48 h postoperatively, while the levels of TNF-α, IL-1 and IL-6 were significantly decreased (P < 0.05).Additionally, the L group experienced less pain on the movement VAS, the decreased OME dosage and a lower rate of PONV within 48 h postoperatively than the C group (P < 0.05). Intravenous infusion of lidocaine during the perioperative period was effective in reducing postoperative inflammatory response and the postoperative suppression of cellular immune function in the body, as well as significantly reducing the level of postoperative pain and the incidence of PONV in patients undergoing VATS.
Postoperative cognitive dysfunction (POCD) has been reported as a significant complication in elderly patients. Various methods have been proposed for reducing the incidence and severity of POCD. Intravenous lidocaine administration has been reported in the literature to reduce POCD, but the effect of lidocaine remains controversial. We screened Medline, Embase, Cochrane Library, and China National Knowledge Infrastructure (up to April 2022) databases following a search strategy for intravenous lidocaine on POCD. We also screened related bibliographies on lidocaine for POCD. Ten articles comprising 1517 patients were selected and analyzed. We divided the postoperative follow-up period as follows: short term (<30 days), medium term (30-90 days), and long term (>90 days). We found that lidocaine could attenuate the overall incidence of POCD, especially in the short term. There were no differences between lidocaine and placebo on the overall severity of POCD. Lidocaine administered intravenously could attenuate the overall incidence of POCD and its severity in the short term.