Pre-Emptive Parecoxib Sodium for Pain Control During CT-Guided Lung Nodule Localization
ConditionLung Nodules
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLong Jiang
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PARECOXIB SODIUM
Drug40mg administered intravenously prior to CT-guided hook wire localization.
0.9 % Normal Saline
DrugVisually identical 0.9% normal saline administered intravenously prior to CT-guided hook wire localization.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Parecoxib SodiumExperimental treatment 1 intervention
Group B: Normal SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes after the withdrawal of the guide needle).Secondary outcomes
1
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.
Time frame
From the time of drug administration to the completion of the localization procedure (assessed up to 6 hours).2
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.
Time frame
Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes).3
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.
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).Other outcomes
1
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.
Time frame
From the start of the CT-guided localization procedure until the induction of general anesthesia for the surgical resection (typically up to 6 hours).2
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.
Time frame
Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes).3
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.
Time frame
From 5 minutes prior to the localization procedure to within 5 minutes after the withdrawal of the guide needle.4
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.
Time frame
From 5 minutes prior to the localization procedure to within 5 minutes after the withdrawal of the guide needle.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Long Jiang
Lead sponsor
Shanghai Chest Hospital
Sponsor institution
Source ClinicalTrials.gov