Not Yet RecruitingEarly Phase 1

Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy

140 participantsStarted 2024-09-01

Plain-language summary

Investigators have designed a randomized controlled trial. Utilizing an open-label, randomized, controlled study methodology, this trial aims to explore a opioid-free, safe, and effective analgesic approach for thoracic surgery. It also seeks to provide clinical guidance for the implementation of opioid-free or reduced-opioid postoperative analgesia in other thoracic procedures, aiming to optimize postoperative pain management for patients and ultimately enhance the overall patients recovery experience.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Aged between 18 and 65 years. * Patients with lung cancer or suspected lung cancer who are undergoing lobectomy surgery via Video-assisted thoracoscopic surgery (VATS) or Robotic-assisted thoracoscopic surgery (RATS). * American anesthesiologist association (ASA) physical status classificationⅠ-Ⅲ. * Surgery is expected to last at least 2 hours, with a minimum of 2 days of postoperative hospitalization. * Patients participate voluntarily and have signed an informed consent form. Exclusion Criteria: * Patients who underwent open-heart surgery. * Patients with BMI ≥30 kg/m², or ≤18.5 kg/m². * Patients who are allergic to any of the local anesthetic drugs, such as ropivacaine, lidocaine, bupivacaine, procaine, bupivacaine, benzocaine, dacronin, etc. * Patients who are allergic to any of the general anesthesia drugs, such as those including propofol, sufentanil, remifentanil, etc. * Patients who currently have active ulcers or have gastrointestinal bleeding or who are allergic to any NSAIDs such as parecoxib sodium, flurbiprofenol ester, and acetaminophen. * Patients with contraindications to epidural spinal plane block (ESPB), such as skin infection near the puncture site or coagulation disorders. * Patients allergic to ultrasound gel. * Patients with significant preoperative renal insufficiency (creatinine more than twice the upper limit of normal). * Patients with severe spinal deformities prior to surgery. * Patients with preoperative distant tumor met…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative 48-h analgesic efficacy at cough

Timeframe: Leave the PACU (T0), postoperative 6 hours (T1)、postoperative 12 hours (T2)、 postoperative 24 hours (T3)、 postoperative 36 hours (T4) and postoperative 48 hours (T5).

Trial details

NCT IDNCT06570538

SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

Contact for this trial

Junqiang Hu, bachelor

17702007842 3336862127@qq.com

View on ClinicalTrials.gov More Postoperative Pain trials