Perioperative high-dose nicotine patch for pain sensitivity in male smokers undergoing thoracic surgery
Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study
We will try a high-dose nicotine patch around the time of surgery to see if it reduces pain sensitivity in adult male smokers having thoracoscopic lung surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Henan Provincial People's Hospital Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT07250230 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men 18–75 who are regular smokers (≥2 years, >10 cigarettes/day in the past 6 months or FTND ≥2), scheduled for thoracoscopic lobectomy/segmental/wedge resection, with BMI 18–28 kg/m2 and ASA I–III.
Not a fit: Women, non-smokers, and patients with severe cardiovascular/cerebrovascular or psychiatric disease, alcohol dependence, long-term sedative or analgesic use, or those not undergoing thoracic surgery are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, perioperative nicotine replacement could reduce postoperative pain sensitivity and lower opioid requirements for male smokers after thoracic surgery.
How similar studies have performed: Prior work supports nicotine replacement for withdrawal and suggests possible analgesic effects, but the specific use of perioperative high-dose transdermal nicotine in thoracic surgery is novel and evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zhengzhou, Henan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.