24-hour IV lidocaine to reduce lung complications after emergency abdominal surgery for infection
Official title: The Effect of Continuous Intravenous Infusion of Lidocaine on Postoperative Pulmonary Complications and Prognosis in Emergency Surgical Patients With Intra-abdominal Infection
Run by Shanghai Zhongshan Hospital · NCT06304779 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 428 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | October 31, 2023 |
| Main results expected | September 30, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT06304779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Zhongshan Hospital,Fudan university
Shanghai, Shanghai Municipality, China Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Driving pressure-guided individualized PEEP vs standard PEEP during upper abdominal surgery
In this randomized trial, adults at higher risk of breathing problems after upper abdominal surgery will try a personalized PEEP level based on the lowest driving pressure and compare it to a fixed PEEP of 5 cmH2O to see if it lowers postoperative lung complications.
-
Letting patients drink clear fluids until called to the operating room to shorten pre-surgery fasting
This project will try letting elective procedure patients drink clear liquids until they're called to the operating room to see if fasting times, comfort, and perioperative outcomes improve.
-
Lowering driving pressure during surgeries with high risk of postoperative lung complications
This trial tests whether using the lowest possible driving pressure during mechanical ventilation instead of standard protective settings helps adults having high-risk surgery avoid postoperative lung complications.
-
Monocyte HLA-DR monitoring to detect immune weakness in severe intra-abdominal infections at risk for fungal invasion
This will test whether measuring monocyte HLA-DR can reveal innate immune weakness in adult ICU patients with severe intra‑abdominal infections who are at risk for invasive Candida.
-
How the length of single-lung ventilation affects lung complications after chest surgery
This project sees if longer single-lung ventilation during thoracic surgery increases postoperative lung complications in adults aged 18–85.
-
Monitoring breathing and activity after abdominal surgery
This study is testing how breathing and activity tips can help people recover better after abdominal surgery by tracking their movements and breathing for a few days.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.