Pre-Emptive Parecoxib Sodium for Pain Control During CT-Guided Lung Nodule Localization (PEARL)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Nodules
• Intervention / Treatment: Drug: PARECOXIB SODIUM; Drug: 0.9 % Normal Saline

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Long Jiang, M.D. & Ph.D.; Phone Number: +862122200743; Email: dylan919@me.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Long Jiang; Phone Number: 13651656310; Email: dylan919@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parecoxib Sodium; Participants in this arm will receive a single intravenous dose of 40mg parecoxib sodium prior to the CT-guided hook wire localization procedure.	Drug: PARECOXIB SODIUM; 40mg administered intravenously prior to CT-guided hook wire localization.
Placebo Comparator: Normal Saline; 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.	Drug: 0.9 % Normal Saline; Visually identical 0.9% normal saline administered intravenously prior to CT-guided hook wire localization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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.	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).

Other Outcome Measures

Outcome Measure	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).
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.

Collaborators and Investigators

• Sponsor: Long Jiang
• Investigators: Principal Investigator: Long Jiang, M.D. & Ph.D., Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pain Management; Lung Nodule; Parecoxib Sodium; Hook Wire; CT-Guided Localization; Pre-Emptive Analgesia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution; parecoxib
• Other Study ID Numbers: IS26091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: Beginning 6 months and ending 36 months following article publication.

IPD Sharing Access Criteria

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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No