24-hour IV lidocaine to reduce lung complications after emergency abdominal surgery for infection

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

This will try a 24-hour continuous intravenous lidocaine infusion to see if it lowers postoperative lung complications in adults having emergency laparotomy for intra-abdominal infection.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 428 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06304779 on ClinicalTrials.gov

What this trial studies

Adults undergoing emergency laparotomy for intra-abdominal infection receive either a continuous 24-hour intravenous infusion of lidocaine or a placebo during general anesthesia. The primary outcome is incidence of postoperative pulmonary complications within two days, including unplanned ventilation, acute respiratory distress syndrome, or postoperative pneumonia. Secondary outcomes include the proportion requiring mechanical ventilation, perioperative organ function, length of hospital stay, and 30-day postoperative outcomes. Standard infection markers and surgical exclusion criteria are used to screen participants.

Who should consider this trial

Good fit: Adults over 18 undergoing emergency surgery for suspected gastrointestinal perforation or obstruction with signs of infection and planned general anesthesia who can give informed consent are the ideal candidates.

Not a fit: Patients with local anesthetic allergy, pregnancy, ongoing renal replacement therapy, significant arrhythmias or heart failure, very low platelet counts, need for immediate secondary surgery for anastomotic leak, or recent participation in other trials are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, this approach could reduce postoperative pulmonary complications, decrease ventilator use, shorten hospital stays, and improve 30-day outcomes.

How similar studies have performed: Prior randomized trials of perioperative systemic lidocaine have shown benefits for pain, opioid use, and recovery after elective abdominal surgery, but applying continuous IV lidocaine specifically to prevent early postoperative pulmonary complications in emergency intra-abdominal infection is relatively novel and not well established.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital,Fudan university — Shanghai, Shanghai Municipality, China (RECRUITING)

Conditions: Postoperative Pulmonary Complications, Intra-abdominal Infection, intra-abdominal infection, lidocaine, postoperative pulmonary complications