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

NCT07675473 | Recruiting Phase 4 DMC

• 1 other identifier: IS26091
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Nodules

Keywords

Parecoxib Sodium; Hook Wire; Lung Nodule; CT-Guided Localization; Pre-Emptive Analgesia; Pain Management

Outcome Measures

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.

  Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes after the withdrawal of the guide needle).

Secondary Outcomes (3)

• 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).

Other Outcomes (4)

• Incidence of Rescue Analgesia Requirement

  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

  Immediately after the completion of the CT-guided hook wire puncture (within 5 minutes).

• Change in Heart Rate (HR)

  From 5 minutes prior to the localization procedure to within 5 minutes after the withdrawal of the guide needle.

Study Arms (2)

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.

Drug: PARECOXIB SODIUM

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.

Drug: 0.9 % Normal Saline

Interventions

PARECOXIB SODIUM DRUG

40mg administered intravenously prior to CT-guided hook wire localization.

Parecoxib Sodium

0.9 % Normal Saline DRUG

Visually identical 0.9% normal saline administered intravenously prior to CT-guided hook wire localization.

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Long Jiang: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

parecoxib; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Long Jiang, M.D. & Ph.D.

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Long Jiang, M.D. & Ph.D.

CONTACT

+862122200743; dylan919@me.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai Chest Hospital

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• 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.

Locations

CN (1)