The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI

The Effect of Continuous Intravenous Infusion of Lidocaine on Postoperative Pulmonary Complications and Prognosis in Emergency Surgical Patients With Intra-abdominal Infection

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intra-abdominal Infection; Postoperative Pulmonary Complications
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 428
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital,Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18 years, any gender.
• Patients suspected of digestive tract perforation or obstruction based on physical examination, confirmed by imaging, requiring emergency surgical treatment.
• The anesthesia method is general anesthesia
• I or the patient's family have carefully read and signed the informed consent form
• Serum procalcitonin (PCT) at inflammatory levels or leukocytosis (>12×109/L) or leukopenia (<4×109/L) or >10% naive leukocytes

Exclusion Criteria:

• Have a history of local anesthesia drug allergy
• Pregnant patients
• Patients receiving renal replacement therapy
• Patients with arrhythmias or heart failure (second or third-degree atrioventricular block or left ventricular ejection fraction [LVEF]
• Preoperative platelet count<80 × 109/L
• Patients who require secondary surgery for postoperative anastomotic fistula
• Patients who have participated in other clinical studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.	Drug: Placebo; atients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.
Experimental: Lidocaine group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of continuous 24-hour intravenous lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for IAI.	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.	within 2 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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."	within 30 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To observe the impact of continuous perioperative lidocaine infusion on the levels of neutrophil extracellular traps (NETs) postoperatively	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	before anesthesia, 24 hours postoperatively, and 7 days postoperatively

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: West China Hospital; Tianjin Medical University General Hospital; The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: lidocaine; postoperative pulmonary complications; intra-abdominal infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Infections; Intraabdominal Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: V3.0.2023.11.29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No