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Recruiting NCT07675473

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

Conditions: Lung Nodules

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 150
Sponsor: Long Jiang

Location: Shanghai Chest Hospital Shanghai Shanghai Municipality

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. 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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07675473). StuddyBuddy aggregates publicly available trial information.