An interventional study of Lidocaine and Placebo in Postoperative Pulmonary Complications and Intra-abdominal Infection, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Prevention
The main purpose of this study is to evaluate the impact of continuous 24-hour intravenous infusion of lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for intra-abdominal infection (IAI).The secondary objectives of this study are to assess the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period, length of hospital stay, and outcomes within 30 days postoperatively.
PPCs are defined as the occurrence within 2 days postoperatively of atelectasis unplanned ventilation, acute respiratory distress syndrome (ARDS), and postoperative pneumonia syndrome Unplanned ventilation postoperatively: Defined as the use of non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) after the first extubation postoperatively or if extubation cannot be performed as planned.
Acute Respiratory Distress Syndrome (ARDS): Defined as acute diffuse inflammatory lung injury leading to increased pulmonary vascular permeability, increased lung weight, loss of aerated lung tissue, hypoxemia, and bilateral opacities on imaging (using the Berlin Consensus definition).
Postoperative pneumonia: Defined according to the diagnostic criteria in the "Chinese Adult Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Diagnosis and Treatment Guidelines" (2018 version): new or progressive infiltrates, consolidation, or ground-glass opacities on chest X-ray or CT, along with two or more of the following clinical symptoms: ① fever (> 38.0°C), ② purulent respiratory secretions, ③ peripheral blood leukocyte count > 10×10\^9/L or \< 4×10\^9/L.
129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.
This study's planned enrollment of 428 is above the median of 140 across 77 interventional studies indexed under Intraabdominal Infections.
Browse Intraabdominal Infections studies →Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.
Drug: Placebo
Patients receive a loading dose of 1.5 mg/kg 2% lidocaine at anesthesia induction, followed by continuous intravenous infusion at 1.5 mg/kg/h until 24 hours postoperatively.
Drug: Lidocaine
Lidocaine group receive a loading dose of 1.5 mg/kg 2% lidocaine at anesthesia induction, followed by continuous intravenous infusion at 1.5 mg/kg/h until 24 hours postoperatively and Control group receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively. Both groups will receive the same anesthesia and postoperative analgesia protocols, lung-protective ventilation strategy, and fluid, transfusion, and warming strategies. The only difference is the intervention during surgery, with the lidocaine group receiving continuous intravenous lidocaine.
Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.
The incidence of PPCs in patients undergoing emergency laparotomy for IAI with or without continuous 24-hour intravenous lidocaine.
PPCs are defined as a syndrome encompassing atelectasis, unplanned mechanical ventilation, acute respiratory distress syndrome (ARDS), and postoperative pneumonia occurring within 2 days after surgery.
Time frame: within 2 days after surgery
Proportion of patients requiring mechanical ventilation and protection of important organ function during the perioperative period: with versus without continuous 24-hour intravenous lidocaine infusion.
The protection of important organ function during the perioperative period is defined as the difference in Sequential Organ Failure Assessment (SOFA) scores between the highest preoperative and postoperative 2-day scores (Delta-SOFA), following the "Sepsis 3.0 International Consensus on Sepsis and Septic Shock."
Time frame: within 30 days postoperatively
Comparison of postoperative levels of neutrophil extracellular traps (NETs) in patients with or without continuous perioperative lidocaine infusion.
Twenty patients from each group will be selected for blood collection before anesthesia, 24 hours postoperatively, and 7 days postoperatively, to explore the potential mechanisms influencing peripheral blood NETs levels
Time frame: before anesthesia, 24 hours postoperatively, and 7 days postoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Sep 2027, 46 months after the start.
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Studies of the drug tested here: Lidocaine