Perioperative high-dose nicotine patch for pain sensitivity in male smokers undergoing thoracic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled pilot compares perioperative high-dose transdermal nicotine patch to usual care or placebo in adult male smokers undergoing thoracoscopic lobectomy, segmental, or wedge resection. Eligible participants are men aged 18–75 with a regular smoking history and ASA physical status I–III who consent to perioperative nicotine replacement. The trial collects perioperative pain sensitivity measures, postoperative pain scores, and analgesic consumption to gauge preliminary effects. Results will inform feasibility and the design of larger trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male, aged 18-75 years, with a body mass index (BMI) of 18-28 kg/m2 Between;
2. Thoracoscopic lobectomy/segmental/wedge resection under general anesthesia;
3. American Society of Anesthesiologists (ASA) classifications I-III Level;
4. Regular smoking for more than 2 years, smoking more than 10 cigarettes per day in the past 6 months, and not successfully quitting smoking within 1 month (after admission, the doctor and nurse informed the smoking cessation plan to intervene before starting to stop smoking or 1 ≤ cigarette count ≤ 10 cigarettes/day in the past month), FTND score ≥ 2;
5. No severe respiratory diseases, no serious cardiovascular and cerebrovascular diseases (hypertension is treated with SBP ≤ 160mmHg, DBP ≤ 90mmHg after systemic treatment);
6. Obtain informed consent.

Exclusion Criteria:

1. Those who have a history of alcoholism, long-term use of sedatives or analgesics;
2. Patients with psychiatric and nervous system diseases (such as Parkinson's, depression, schizophrenia) and severe audio-visual dysfunction before surgery;
3. Preoperative systolic blood pressure \> 180mmHg or diastolic blood pressure \> 110mmHg;
4. Patients who were converted to thoracotomy during thoracoscopic surgery
5. Patients who are transferred to the intensive care unit after surgery;
6. Patients who refuse to use analgesic pump treatment/do not configure the analgesic pump according to regulations;
7. Patients who have self-removed patches/short hospital stay resulting in a postoperative observation time of \< 48 hours

Where it's running

• Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Wei Li
• Email: 1131691709@qq.com
• Phone: +8619838263779

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.