Postoperative Pulmonary Complications (PPCs)Phase 3NCT07000760
Intraoperative Nebulization of Lidocaine and Postoperative Pulmonary Complications
A Phase 3 study testing Nebulization of lidocaine and Nebulization of normal saline in people with Postoperative Pulmonary Complications (PPCs), run by Jun Zhang at 2 sites in China.
Trial summary
There is high incidence of postoperative pulmonary complications (PPCs) in patients undergoing major abdominal surgeries.PPCs significantly prolongs the hospital stay of patients, increases their economic burden, and raises the mortality rates within 30 days and 1 year after surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Pulmonary Complications (PPCs)
- What is being tested?
- Nebulization of lidocaine and Nebulization of normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 2 sitesChina
- Study dates
- 6 Jun 2025to 30 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have signed the informed consent form and are willing to complete the study according to the protocol
- Age ≥18 years old and ≤90 years old
- ASA classification grades I-III
- Elective major non-cardiac surgery
- General anesthesia under tracheal intubation
- Monitor invasive arterial blood pressure
- The expected operation time ≥2 hours
Who cannot join
- Untreated ischemic heart disease Severe cardiovascular and cerebrovascular diseases
- Severe asthma, pulmonary bullae, pneumothorax, bronchopleural fistula, etc
- Severe underlying liver and kidney diseases
- Age under 18 years old or over 90 years old
- The expected operation time is ≥2 hours
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, 200032
Fudan University Shanghai Cancer Center
Shanghai
About this study
There is high incidence of postoperative pulmonary complications (PPCs) in patients undergoing major abdominal surgeries.PPCs significantly prolongs the hospital stay of patients, increases their economic burden, and raises the mortality rates within 30 days and 1 year after surgery. The inflammatory response during the perioperative period plays an important role in the occurrence and development of PPCs. The anti-inflammatory effect of lidocaine has a potential lung protection mechanism. The purpose of this study is to explore the effect of nebulization of lidocaine on the incidence of PPCs. The investigators hypothesized that intraoperative nebulization of lidocaine could reduce the incidence of PPCs.
Read the detailed description
Introduction Globally, over 313 million surgical procedures are performed annually, with postoperative pulmonary complications (PPCs) occurring in 5-33% of cases. PPCs, the second most common postoperative complication after surgical site infections, encompass conditions such as respiratory infections, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia. These complications significantly prolong hospital stays, increase healthcare costs, and elevate 30-day and 1-year mortality rates.
Pathophysiology of PPCs PPCs are closely linked to perioperative pulmonary inflammatory responses. Mechanical ventilation during general anesthesia alters pulmonary ventilation distribution, leading to atelectasis in over 90% of patients. Atelectasis increases mechanical stress and hypoxia in collapsed lung regions while causing hyperinflation and hyperoxia in adjacent areas. These conditions promote the release of pro-inflammatory cytokines, reactive oxygen species, and leukocyte infiltration. Additionally, atelectasis-induced hypoxia and mechanical stress contribute to endothelial damage, increasing vascular permeability and protein leakage. Major abdominal and thoracic surgeries further exacerbate systemic inflammation and airway hyperreactivity, impairing alveolar epithelial barrier function and mucociliary clearance.
Lidocaine's Anti-Inflammatory and Lung-Protective Mechanisms Lidocaine has emerged as a potential therapeutic agent due to its anti-inflammatory properties. Studies indicate that it inhibits neutrophil infiltration and reduces pro-inflammatory cytokines (e.g., IL-6, TNF-α) by blocking Toll-like receptor 4/NF-κB signaling. Inhaled lidocaine has shown efficacy in murine asthma models by suppressing GATA-3 expression, eosinophilic inflammation, mucus overproduction, and airway hyperreactivity. It has also been explored as an adjunct therapy for severe COVID-19 respiratory symptoms, mitigating cytokine storms and improving outcomes. In pediatric patients, lidocaine reduces postoperative cough incidence.
Current Challenges and the Promise of Nebulization Despite its potential, lidocaine's clinical application for lung protection remains inconsistent. Intravenous administration poses risks due to narrow therapeutic windows, with fluctuating plasma concentrations potentially causing neurotoxicity or cardiotoxicity. nebulized lidocaine achieve direct anti-inflammatory effects within the pulmonary compartment.
Research Objective and Hypothesis The role of nebulization lidocaine in reducing PPCs remains underexplored. This study aims to evaluate its impact on PPC incidence within seven days post-surgery. The hypothesis is that intraoperative nebulized lidocaine administration will decrease PPC rates, offering a safer and more effective approach to perioperative lung protection.
- Being tested
- Nebulization of lidocaine, Nebulization of normal saline
- Keywords
- Postoperative pulmonary complications, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization of lidocaineDrug
Also called 1
After induction of general anesthesia and before the end of the surgery, 100mg of 2% lidocaine was nebulized and inhaled respectively, and the nebulization time was 15-20 minutes each time.
Nebulization of normal salineDrug
Also called 2
After anesthesia induction and before the end of the surgery, the same volume of normal saline (5ml of 0.9% NaCl) was nebulized, and the nebulization time was 15-20 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Experimental | After anesthetic induction and before the end of the surgery, 100mg of 2% lidocaine was nebulized and inhaled respectively. Receives: Drug: Nebulization of lidocaine |
| saline | Placebo comparator | After anesthetic induction and before the end of the surgery, the same volume of normal saline (5ml of 0.9% NaCl) was nebulized. Receives: Drug: Nebulization of normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PPCs within seven days after surgery
Measured: Up to one week
Secondary outcomes (3)
ICU admission rate
Measured: Up to one week
Hospital stay
Measured: Perioperative
Postoperative pain score
Postoperative pain was assessed using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 represents the most severe pain.
Measured: Up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start6 Jun 2025
- Primary completion23 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary Complications (PPCs)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Zhang, Fudan University
- Investigators
- Jun Zhang Fudan University Shanghai Cancer Centre, Professor, Study chair, Fudan University Shanghai Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000760
- Sponsor's protocol ID
- 2504-Exp179
- Status last verified
- Mar 2026
- First submitted
- 22 May 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sets are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Nebulization of Lidocaine and Postoperative Pulmonary Complications
- ClinicalTrials.gov ID
- NCT07000760
- Acronym / sponsor ID
- 2504-Exp179
- Keywords
- Postoperative pulmonary complications, Lidocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 3 Jun 2025 (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.
There is high incidence of postoperative pulmonary complications (PPCs) in patients undergoing major abdominal surgeries.PPCs significantly prolongs the hospital stay of patients, increases their economic burden, and raises the mortality rates within 30 days and 1 year after surgery. The inflammatory response during the perioperative period plays an important role in the occurrence and development of PPCs. The anti-inflammatory effect of lidocaine has a potential lung protection mechanism. The purpose of this study is to explore the effect of nebulization of lidocaine on the incidence of PPCs. The investigators hypothesized that intraoperative nebulization of lidocaine could reduce the incidence of PPCs.
Detailed description
Introduction Globally, over 313 million surgical procedures are performed annually, with postoperative pulmonary complications (PPCs) occurring in 5-33% of cases. PPCs, the second most common postoperative complication after surgical site infections, encompass conditions such as respiratory infections, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia. These complications significantly prolong hospital stays, increase healthcare costs, and elevate 30-day and 1-year mortality rates.
Pathophysiology of PPCs PPCs are closely linked to perioperative pulmonary inflammatory responses. Mechanical ventilation during general anesthesia alters pulmonary ventilation distribution, leading to atelectasis in over 90% of patients. Atelectasis increases mechanical stress and hypoxia in collapsed lung regions while causing hyperinflation and hyperoxia in adjacent areas. These conditions promote the release of pro-inflammatory cytokines, reactive oxygen species, and leukocyte infiltration. Additionally, atelectasis-induced hypoxia and mechanical stress contribute to endothelial damage, increasing vascular permeability and protein leakage. Major abdominal and thoracic surgeries further exacerbate systemic inflammation and airway hyperreactivity, impairing alveolar epithelial barrier function and mucociliary clearance.
Lidocaine's Anti-Inflammatory and Lung-Protective Mechanisms Lidocaine has emerged as a potential therapeutic agent due to its anti-inflammatory properties. Studies indicate that it inhibits neutrophil infiltration and reduces pro-inflammatory cytokines (e.g., IL-6, TNF-α) by blocking Toll-like receptor 4/NF-κB signaling. Inhaled lidocaine has shown efficacy in murine asthma models by suppressing GATA-3 expression, eosinophilic inflammation, mucus overproduction, and airway hyperreactivity. It has also been explored as an adjunct therapy for severe COVID-19 respiratory symptoms, mitigating cytokine storms and improving outcomes. In pediatric patients, lidocaine reduces postoperative cough incidence.
Current Challenges and the Promise of Nebulization Despite its potential, lidocaine's clinical application for lung protection remains inconsistent. Intravenous administration poses risks due to narrow therapeutic windows, with fluctuating plasma concentrations potentially causing neurotoxicity or cardiotoxicity. nebulized lidocaine achieve direct anti-inflammatory effects within the pulmonary compartment.
Research Objective and Hypothesis The role of nebulization lidocaine in reducing PPCs remains underexplored. This study aims to evaluate its impact on PPC incidence within seven days post-surgery. The hypothesis is that intraoperative nebulized lidocaine administration will decrease PPC rates, offering a safer and more effective approach to perioperative lung protection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Experimental | Drug: Nebulization of lidocaineAfter anesthetic induction and before the end of the surgery, 100mg of 2% lidocaine was nebulized and inhaled respectively. |
| saline | Placebo comparator | Drug: Nebulization of normal salineAfter anesthetic induction and before the end of the surgery, the same volume of normal saline (5ml of 0.9% NaCl) was nebulized. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have signed the informed consent form and are willing to complete the study according to the protocol
- Age ≥18 years old and ≤90 years old
- ASA classification grades I-III
- Elective major non-cardiac surgery
- General anesthesia under tracheal intubation
Key exclusion criteria (5 listed)
- Untreated ischemic heart disease Severe cardiovascular and cerebrovascular diseases
- Severe asthma, pulmonary bullae, pneumothorax, bronchopleural fistula, etc
- Severe underlying liver and kidney diseases
- Age under 18 years old or over 90 years old
- The expected operation time is ≥2 hours
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 |
|---|---|---|
| Nebulization of lidocaineAlso: 1After induction of general anesthesia and before the end of the surgery, 100mg of 2% lidocaine was nebulized and inhaled respectively, and the nebulization time was 15-20 minutes each time. | Drug | lidocaine |
| Nebulization of normal salineAlso: 2After anesthesia induction and before the end of the surgery, the same volume of normal saline (5ml of 0.9% NaCl) was nebulized, and the nebulization time was 15-20 minutes each time. | Drug | saline |
Primary outcome
The incidence of PPCs within seven days after surgery
Time frame: Up to one week
3 secondary outcomes
ICU admission rate
Time frame: Up to one week
Hospital stay
Time frame: Perioperative
Postoperative pain score
Time frame: Up to one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No. The data sets are available from the corresponding author on reasonable request.
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Not yet recruitingObservational study
Physical Function Before Surgery and Lung Complications After Lung Surgery
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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. This study is not recruiting at the moment.
Jun Zhang Fudan University Shanghai Cancer Centre, Professor study chair
Fudan University Shanghai Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nebulization of lidocaine and Nebulization of normal saline in people with Postoperative Pulmonary Complications (PPCs), run by Jun Zhang at 2 sites 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PPCs within seven days after surgery (time frame: Up to one week). 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 10 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.