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

NCT06304779 | Recruiting

• 1 other identifier: V3.0.2023.11.29
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pulmonary Complications; Intra-abdominal Infection

Keywords

intra-abdominal infection; lidocaine; postoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

• 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.

  within 2 days after surgery

Secondary Outcomes (1)

• 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.

  within 30 days postoperatively

Other Outcomes (1)

• Comparison of postoperative levels of neutrophil extracellular traps (NETs) in patients with or without continuous perioperative lidocaine infusion.

  before anesthesia, 24 hours postoperatively, and 7 days postoperatively

Study Arms (2)

Control group

PLACEBO COMPARATOR

Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.

Drug: Placebo

Lidocaine group

EXPERIMENTAL

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

Interventions

Lidocaine DRUG

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.

Lidocaine group

Placebo DRUG

Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• West China Hospital: collaborator

Study Sites (1)

Zhongshan Hospital,Fudan university

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Control group: Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: October 31, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)