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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARECOXIB SODIUM | Drug | 40mg administered intravenously prior to CT-guided hook wire localization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes after the withdrawal of the guide needle). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Rescue Analgesia Requirement | The percentage of participants requiring the temporary administration of additional pain relief medications (such as opioids) due to intolerable pain (e.g., a Visual Analog Scale score of 7 or higher) during or immediately after the CT-guided hook wire localization procedure. This measure reflects the clinical failure rate of the pre-emptive analgesic strategy. | From the start of the CT-guided localization procedure until the induction of general anesthesia for the surgical resection (typically up to 6 hours). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Long Jiang, M.D. & Ph.D. | Contact | +862122200743 | dylan919@me.com |
| Name | Affiliation | Role |
|---|---|---|
| Long Jiang, M.D. & Ph.D. | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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).
Beginning 6 months and ending 36 months following article publication.
Who: Researchers who provide a methodologically sound research proposal that is approved by the Institutional Review Board (IRB) or an independent review committee.
What: De-identified individual participant data (IPD) underlying the published results, along with the Study Protocol and Statistical Analysis Plan.
How: Requests should be submitted via email to the corresponding author dylan919@me.com. Data sharing is subject to institutional approval, ethical clearance, and the execution of a strict data transfer agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2026 | Jun 22, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 29, 2026 | Jun 22, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C409945 | parecoxib |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 0.9 % Normal Saline | Drug | Visually identical 0.9% normal saline administered intravenously prior to CT-guided hook wire localization. |
|
| 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. | 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. | 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). |
| Physician Satisfaction Score Regarding Patient Compliance | The level of patient compliance during the puncture procedure (e.g., ability to hold breath steadily, maintaining posture) evaluated by the physician performing the CT-guided localization. Measured using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates "completely dissatisfied / complete inability to comply" and 10 indicates "completely satisfied / perfect compliance." Unit of Measure: 0-10 score. | Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes). |
| Change in Heart Rate (HR) | The change in the participant's heart rate, measured in beats per minute (bpm), comparing the value immediately before the CT-guided puncture to the value immediately after the withdrawal of the guide needle. A larger positive change indicates a stronger sympathetic stress response to pain. | From 5 minutes prior to the localization procedure to within 5 minutes after the withdrawal of the guide needle. |
| Change in Mean Arterial Pressure (MAP) | The change in the participant's mean arterial pressure, measured in millimeters of mercury (mmHg), comparing the value immediately before the CT-guided puncture to the value immediately after the withdrawal of the guide needle. A larger positive change indicates a stronger physiological stress response to pain. | From 5 minutes prior to the localization procedure to within 5 minutes after the withdrawal of the guide needle. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |