Postoperative Pulmonary ComplicationsPPCsNCT06304779
The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI
A study testing Lidocaine in people with Postoperative Pulmonary Complications and Intra-abdominal Infection, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Pulmonary Complications, Intra-abdominal Infection
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital,Fudan university
Shanghai, Shanghai Municipality, 200032
Wankun Chen, professor, 18017317651, chenwank@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Lidocaine, Placebo
- Keywords
- intra-abdominal infection, lidocaine, postoperative pulmonary complications
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
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.
PlaceboDrug
Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively. Receives: 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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."
Measured: within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start31 Oct 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, West China Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304779
- Sponsor's protocol ID
- V3.0.2023.11.29
- Acronym
- PPCs
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Intravenous Infusion of Lidocaine on Postoperative Pulmonary Complications and Prognosis in Emergency Surgical Patients With Intra-abdominal Infection
- ClinicalTrials.gov ID
- NCT06304779
- Acronym / sponsor ID
- PPCs / V3.0.2023.11.29
- Keywords
- intra-abdominal infection, lidocaine, postoperative pulmonary complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, West China Hospital
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: PlaceboPatients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively. |
| Lidocaine group | Experimental | Drug: LidocainePatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineLidocaine 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. | Drug | Lidocaine group |
| PlaceboPatients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively. | Drug | Control group |
Primary outcome
The incidence of PPCs in patients undergoing emergency laparotomy for IAI with or without continuous 24-hour intravenous lidocaine.
Time frame: within 2 days after surgery
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.
1 secondary outcome
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.
Time frame: within 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Postoperative Pulmonary Complications and Intra-abdominal Infection, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PPCs in patients undergoing emergency laparotomy for IAI with or without continuous 24-hour intravenous lidocaine. (time frame: within 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.