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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain Intensity Assessed by Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Pain Intensity Assessed by Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Optimal Dosing Time Window for Pre-Emptive Analgesia(From the time of drug administration to the completion of the localization procedure (assessed up to 6 hours).)
- Overall Patient Satisfaction Score(Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes).)
- Number of Participants Experiencing Localization-Related Complications(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).)
研究者
Long Jiang
Shanghai Chest Hospital
Shanghai Chest Hospital