Lung NodulesPhase 4PEARLNCT07675473
Pre-Emptive Parecoxib Sodium for Pain Control During CT-Guided Lung Nodule Localization
A Phase 4 study testing PARECOXIB SODIUM and 0.9 % Normal Saline in people with Lung Nodules, run by Long Jiang at 1 site in China.
Trial summary
Before undergoing minimally invasive lung surgery, patients with small lung nodules often need a procedure called "CT-guided hook wire localization." This involves using a CT scanner to help doctors place a tiny wire in the lung to mark the exact location of the nodule for the surgeon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Nodules
- What is being tested?
- PARECOXIB SODIUM and 0.9 % Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 15 Jun 2028
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agreed to participate in the study and signed the informed consent form approved by the Ethics Committee.
- Male or female adult patients aged 18 years or older.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) scheduled for Video-Assisted Thoracoscopic Surgery (VATS).
- Requires preoperative CT-guided hook wire localization of lung nodules.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- American Society of Anesthesiologists (ASA) physical status classification of I or II.
- Fully conscious with no psychiatric or neurological disorders, and capable of fully understanding and correctly using the Visual Analog Scale (VAS) for pain assessment.
Who cannot join
- Known history of hypersensitivity to parecoxib sodium, other COX-2 inhibitors, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
- History or presence of active peptic ulcer disease, gastrointestinal bleeding, or gastrointestinal perforation.
- Severe cardiovascular diseases, including but not limited to unstable angina, history of myocardial infarction within the past 6 months, severe arrhythmias, or poorly controlled hypertension.
- Coagulation disorders with a bleeding tendency (e.g., hemophilia) or currently receiving full-dose anticoagulation therapy, which the investigator believes may significantly increase the bleeding risk of the hook wire localization.
- Severe, uncontrolled pulmonary diseases (e.g., severe chronic obstructive pulmonary disease [COPD], interstitial pneumonia) that the investigator believes pose an unacceptable risk for the procedure.
- Currently using other analgesic medications that cannot be discontinued during the study period.
- Any other conditions that, in the investigator's judgment, might interfere with the outcome assessment or increase the risk to the subject.
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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Long Jiang, 13651656310, dylan919@139.com
About this study
Official title: Application of Pre-Emptive Analgesia With Parecoxib Sodium in CT-Guided Hook Wire Localization of Lung Nodules Before Video-Assisted Thoracoscopic Surgery and Exploration of the Optimal Clinical Dosing Window: A Single-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Before undergoing minimally invasive lung surgery, patients with small lung nodules often need a procedure called "CT-guided hook wire localization." This involves using a CT scanner to help doctors place a tiny wire in the lung to mark the exact location of the nodule for the surgeon. While very helpful for the surgery, this wire placement can be highly painful for patients.
The main purpose of this clinical trial is to find out if giving patients a pain-relieving medication called parecoxib sodium before the procedure can effectively reduce their pain. Parecoxib sodium is a standard, non-opioid painkiller given through an IV.
Read more
Additionally, researchers want to discover the best time to give this medication. Because operating room schedules can change, patients will receive the IV medication at different times before their localization procedure (ranging from less than an hour to more than 3 hours beforehand). By looking at these different wait times, researchers hope to identify the "golden window"-the exact timing that provides the most pain relief.
During the study, participants will be randomly assigned by a computer to one of two groups:
The Study Group: Will receive the active pain medication (parecoxib sodium).
The Control Group: Will receive a placebo (a saltwater solution with no active medicine).
To ensure the results are fair and unbiased, participants have a 2 in 3 chance of receiving the active medication, and neither the patients nor their doctors will know which assignment they received. Immediately after the wire is placed, participants will be asked to rate their pain on a scale of 0 to 10.
By comparing the pain scores between the two groups and looking at the different medication timings, researchers hope to create better, more comfortable care guidelines for future lung surgery patients.
Read the detailed description
Background and Scientific Rationale Preoperative CT-guided hook wire localization is a critical step in Video-Assisted Thoracoscopic Surgery (VATS) for the precise resection of small, indeterminate lung nodules. However, the puncture of the parietal pleura induces acute, severe pain. This pain not only impairs the patient's perioperative experience but also leads to poor compliance (such as the inability to hold breath), which significantly increases the risk of procedure-related complications including pneumothorax, intrapulmonary hemorrhage, and wire dislodgement.
Parecoxib sodium, a highly selective COX-2 inhibitor, is widely used for perioperative pain management due to its strong analgesic properties and lack of interference with platelet function. While its theoretical pharmacokinetic profile suggests a peak analgesic effect between 1.5 to 2 hours post-administration, the inherent unpredictability of sequential operating room schedules makes a rigid, fixed preoperative dosing time highly impractical in real-world clinical settings.
Study Design and Methodology This is a single-center, prospective, randomized, double-blind, placebo-controlled clinical trial. The study employs a 2:1 asymmetric randomization ratio (Parecoxib Sodium : Placebo) stratified by the expected number of localized nodules (single vs. multiple). This specific ratio is designed to maximize the collection of real-world timing data in the intervention group while maintaining adequate statistical power against the control group.
Allocation concealment is strictly enforced using sequentially numbered, opaque, sealed envelopes (or an equivalent centralized electronic system). The study drug and placebo (0.9% normal saline) are prepared by an independent, unblinded research nurse to ensure identical volume and appearance. The patients, localization physicians, surgeons, and follow-up assessors remain completely blinded to the treatment assignment.
The "Natural Time Gradient" and Optimization Strategy A core methodological innovation of this trial is the embrace of the unpredictable nature of surgical wait times. Rather than enforcing a strict dosing schedule, the protocol dictates that the study drug be administered on an event-driven basis (e.g., when the preceding surgery enters the closure phase or upon a transport call from the CT suite).
This approach naturally generates a time gradient of administration-to-puncture intervals (ranging from roughly 30 minutes to over 6 hours). Researchers will record precise timestamps for both the intravenous administration (T1) and the moment of CT-guided puncture (T2).
Data Analysis and Clinical Translation While the primary objective tests the overall efficacy of pre-emptive parecoxib sodium in reducing immediate post-puncture pain, the critical secondary objective is to define the "golden clinical window" for this intervention.
By utilizing Restricted Cubic Splines (RCS) modeling, the research team will analyze the exact time interval ($\Delta T = T2 - T1$) as a continuous variable against the reported pain scores. This non-linear analysis aims to plot a dose-time-effect curve, pinpointing the optimal timeframe for drug administration. The ultimate goal is to translate these findings into a standardized, evidence-based Standard Operating Procedure (SOP) for perioperative pain management in minimally invasive thoracic surgery.
- Conditions
- Lung Nodules
- Being tested
- PARECOXIB SODIUM, 0.9 % Normal Saline
- Keywords
- Parecoxib Sodium, Hook Wire, Lung Nodule, CT-Guided Localization, Pre-Emptive Analgesia, Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARECOXIB SODIUMDrug
40mg administered intravenously prior to CT-guided hook wire localization.
0.9 % Normal SalineDrug
Visually identical 0.9% normal saline administered intravenously prior to CT-guided hook wire localization.
| Study group | Role | What they receive |
|---|---|---|
| Parecoxib Sodium | Experimental | Participants in this arm will receive a single intravenous dose of 40mg parecoxib sodium prior to the CT-guided hook wire localization procedure. Receives: Drug: PARECOXIB SODIUM |
| Normal Saline | Placebo comparator | Participants in this arm will receive a single intravenous dose of 0.9% normal saline (visually identical to the experimental drug) prior to the CT-guided hook wire localization procedure. Receives: Drug: 0.9 % Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Assessed by Visual Analog Scale (VAS)
Pain intensity experienced by the patient during the CT-guided localization procedure will be evaluated using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates "no pain at all" and 10 indicates "the worst imaginable pain." Unit of Measure: 0-10 score.
Measured: Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes after the withdrawal of the guide needle).
Secondary outcomes (3)
Optimal Dosing Time Window for Pre-Emptive Analgesia
The optimal time interval between drug administration and the localization procedure will be determined. The exact time of intravenous drug administration (T1) and the exact time of CT-guided puncture (T2) will be recorded to calculate the interval (ΔT). The non-linear relationship between ΔT and the primary outcome (VAS pain score) will be analyzed using Restricted Cubic Splines (RCS) modeling to identify the time frame (in minutes) that provides maximum pain relief.
Measured: From the time of drug administration to the completion of the localization procedure (assessed up to 6 hours).
Overall Patient Satisfaction Score
Patient satisfaction with the pain management during the CT-guided localization procedure will be evaluated using an 11-point Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "completely dissatisfied" and 10 indicates "completely satisfied." Unit of Measure: 0-10 score.
Measured: Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes).
Number of Participants Experiencing Localization-Related Complications
The number of participants who experience at least one complication directly related to the hook wire localization procedure. Complications monitored as a composite aggregate include pneumothorax, local intrapulmonary hemorrhage, and hook wire dislodgement. This single aggregate measure evaluates the safety profile and the potential impact of patient compliance (due to pain) on procedure success.
Measured: From the start of the CT-guided localization procedure until the induction of general anesthesia for the surgical resection (typically within 1 to 6 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NodulesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Long Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Long Jiang, Shanghai Chest Hospital
- Investigators
- Long Jiang, M.D. & Ph.D., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675473
- Sponsor's protocol ID
- IS26091
- Acronym
- PEARL
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected de-identified individual participant data (IPD) that underlie the results reported in the primary publication will be shared. This specifically includes demographic data, group assignment, precise timestamps for drug administration and the localization procedure (T1 and T2), primary outcome data (VAS pain scores), and secondary outcome data (patient satisfaction scores, rescue analgesia requirements, and incidence of procedure-related complications).
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Pre-Emptive Analgesia With Parecoxib Sodium in CT-Guided Hook Wire Localization of Lung Nodules Before Video-Assisted Thoracoscopic Surgery and Exploration of the Optimal Clinical Dosing Window: A Single-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07675473
- Acronym / sponsor ID
- PEARL / IS26091
- Conditions
- Lung Nodules
- Keywords
- Parecoxib Sodium, Hook Wire, Lung Nodule, CT-Guided Localization, Pre-Emptive Analgesia, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Long JiangUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 30 Jun 2026 (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.
Before undergoing minimally invasive lung surgery, patients with small lung nodules often need a procedure called "CT-guided hook wire localization." This involves using a CT scanner to help doctors place a tiny wire in the lung to mark the exact location of the nodule for the surgeon. While very helpful for the surgery, this wire placement can be highly painful for patients.
The main purpose of this clinical trial is to find out if giving patients a pain-relieving medication called parecoxib sodium before the procedure can effectively reduce their pain. Parecoxib sodium is a standard, non-opioid painkiller given through an IV.
Additionally, researchers want to discover the best time to give this medication. Because operating room schedules can change, patients will receive the IV medication at different times before their localization procedure (ranging from less than an hour to more than 3 hours beforehand). By looking at these different wait times, researchers hope to identify the "golden window"-the exact timing that provides the most pain relief.
During the study, participants will be randomly assigned by a computer to one of two groups:
The Study Group: Will receive the active pain medication (parecoxib sodium).
The Control Group: Will receive a placebo (a saltwater solution with no active medicine).
To ensure the results are fair and unbiased, participants have a 2 in 3 chance of receiving the active medication, and neither the patients nor their doctors will know which assignment they received. Immediately after the wire is placed, participants will be asked to rate their pain on a scale of 0 to 10.
By comparing the pain scores between the two groups and looking at the different medication timings, researchers hope to create better, more comfortable care guidelines for future lung surgery patients.
Detailed description
Background and Scientific Rationale Preoperative CT-guided hook wire localization is a critical step in Video-Assisted Thoracoscopic Surgery (VATS) for the precise resection of small, indeterminate lung nodules. However, the puncture of the parietal pleura induces acute, severe pain. This pain not only impairs the patient's perioperative experience but also leads to poor compliance (such as the inability to hold breath), which significantly increases the risk of procedure-related complications including pneumothorax, intrapulmonary hemorrhage, and wire dislodgement.
Parecoxib sodium, a highly selective COX-2 inhibitor, is widely used for perioperative pain management due to its strong analgesic properties and lack of interference with platelet function. While its theoretical pharmacokinetic profile suggests a peak analgesic effect between 1.5 to 2 hours post-administration, the inherent unpredictability of sequential operating room schedules makes a rigid, fixed preoperative dosing time highly impractical in real-world clinical settings.
Study Design and Methodology This is a single-center, prospective, randomized, double-blind, placebo-controlled clinical trial. The study employs a 2:1 asymmetric randomization ratio (Parecoxib Sodium : Placebo) stratified by the expected number of localized nodules (single vs. multiple). This specific ratio is designed to maximize the collection of real-world timing data in the intervention group while maintaining adequate statistical power against the control group.
Allocation concealment is strictly enforced using sequentially numbered, opaque, sealed envelopes (or an equivalent centralized electronic system). The study drug and placebo (0.9% normal saline) are prepared by an independent, unblinded research nurse to ensure identical volume and appearance. The patients, localization physicians, surgeons, and follow-up assessors remain completely blinded to the treatment assignment.
The "Natural Time Gradient" and Optimization Strategy A core methodological innovation of this trial is the embrace of the unpredictable nature of surgical wait times. Rather than enforcing a strict dosing schedule, the protocol dictates that the study drug be administered on an event-driven basis (e.g., when the preceding surgery enters the closure phase or upon a transport call from the CT suite).
This approach naturally generates a time gradient of administration-to-puncture intervals (ranging from roughly 30 minutes to over 6 hours). Researchers will record precise timestamps for both the intravenous administration (T1) and the moment of CT-guided puncture (T2).
Data Analysis and Clinical Translation While the primary objective tests the overall efficacy of pre-emptive parecoxib sodium in reducing immediate post-puncture pain, the critical secondary objective is to define the "golden clinical window" for this intervention.
By utilizing Restricted Cubic Splines (RCS) modeling, the research team will analyze the exact time interval ($\Delta T = T2 - T1$) as a continuous variable against the reported pain scores. This non-linear analysis aims to plot a dose-time-effect curve, pinpointing the optimal timeframe for drug administration. The ultimate goal is to translate these findings into a standardized, evidence-based Standard Operating Procedure (SOP) for perioperative pain management in minimally invasive thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parecoxib Sodium | Experimental | Drug: PARECOXIB SODIUMParticipants in this arm will receive a single intravenous dose of 40mg parecoxib sodium prior to the CT-guided hook wire localization procedure. |
| Normal Saline | Placebo comparator | Drug: 0.9 % Normal SalineParticipants in this arm will receive a single intravenous dose of 0.9% normal saline (visually identical to the experimental drug) prior to the CT-guided hook wire localization procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily agreed to participate in the study and signed the informed consent form approved by the Ethics Committee.
- Male or female adult patients aged 18 years or older.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) scheduled for Video-Assisted Thoracoscopic Surgery (VATS).
- Requires preoperative CT-guided hook wire localization of lung nodules.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (7 listed)
- Known history of hypersensitivity to parecoxib sodium, other COX-2 inhibitors, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
- History or presence of active peptic ulcer disease, gastrointestinal bleeding, or gastrointestinal perforation.
- Severe cardiovascular diseases, including but not limited to unstable angina, history of myocardial infarction within the past 6 months, severe arrhythmias, or poorly controlled hypertension.
- Coagulation disorders with a bleeding tendency (e.g., hemophilia) or currently receiving full-dose anticoagulation therapy, which the investigator believes may significantly increase the bleeding risk of the hook wire localization.
- Severe, uncontrolled pulmonary diseases (e.g., severe chronic obstructive pulmonary disease [COPD], interstitial pneumonia) that the investigator believes pose an unacceptable risk for the procedure.
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 |
|---|---|---|
| PARECOXIB SODIUM40mg administered intravenously prior to CT-guided hook wire localization. | Drug | Parecoxib Sodium |
| 0.9 % Normal SalineVisually identical 0.9% normal saline administered intravenously prior to CT-guided hook wire localization. | Drug | Normal Saline |
Primary outcome
Pain Intensity Assessed by Visual Analog Scale (VAS)
Time frame: Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes after the withdrawal of the guide needle).
Pain intensity experienced by the patient during the CT-guided localization procedure will be evaluated using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates "no pain at all" and 10 indicates "the worst imaginable pain." Unit of Measure: 0-10 score.
3 secondary outcomes
Optimal Dosing Time Window for Pre-Emptive Analgesia
Time frame: From the time of drug administration to the completion of the localization procedure (assessed up to 6 hours).
Overall Patient Satisfaction Score
Time frame: Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes).
Number of Participants Experiencing Localization-Related Complications
Time frame: From the start of the CT-guided localization procedure until the induction of general anesthesia for the surgical resection (typically within 1 to 6 hours).
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 30 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected de-identified individual participant data (IPD) that underlie the results reported in the primary publication will be shared. This specifically includes demographic data, group assignment, precise timestamps for drug administration and the localization procedure (T1 and T2), primary outcome data (VAS pain scores), and secondary outcome data (patient satisfaction scores, rescue analgesia requirements, and incidence of procedure-related complications).
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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.
Long Jiang, M.D. & Ph.D. principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PARECOXIB SODIUM and 0.9 % Normal Saline in people with Lung Nodules, run by Long Jiang 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 7 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 30 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Long Jiang, M.D. & Ph.D. (+862122200743, dylan919@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessed by Visual Analog Scale (VAS) (time frame: Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes after the withdrawal of the guide needle).). 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 30 Jun 2026.