Actively Recruiting
Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study
Led by Henan Provincial People's Hospital · Updated on 2026-01-22
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a high-dose nicotine patch on pain sensitivity in male tobacco smokers who stop smoking before thoracic surgery. Smoking is a major risk factor for complications after surgery and is linked to higher mortality and more postoperative problems. Nicotine withdrawal symptoms and increased opioid use after surgery make pain management challenging, prompting this study to explore nicotine patches as a potential aid during surgery recovery. Participants receive either a nicotine patch or a placebo patch starting 24 hours before surgery and continuing for 48 hours after. The nicotine patch dose depends on the number of cigarettes smoked daily, with one 21 mg patch per 20 cigarettes or a 42 mg patch for those smoking 40 or more cigarettes. Patches are applied to the arm, chest, or back with cleaned skin. The control group receives a placebo patch matching the nicotine patch's appearance and placement. During the study, participants undergo thoracoscopic lung surgery under general anesthesia. Researchers monitor pain by measuring analgesic pump dosage used within 48 hours post-surgery. Other assessments include clinical evaluations and monitoring for any postoperative complications or adverse reactions. The study aims to observe differences in opioid use and pain management between the nicotine patch group and placebo group over the immediate postoperative period.
CONDITIONS
Brief Title
Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, aged 18 to 75 years, with a body mass index (BMI) between 18 and 28 kg/m2
- Scheduled for thoracoscopic lobectomy, segmental, or wedge resection under general anesthesia
- American Society of Anesthesiologists (ASA) classification level I to III
- Regular smoking for more than 2 years, smoking over 10 cigarettes per day in the past 6 months
- Not successfully quit smoking within 1 month before admission, or smoking 1 to 10 cigarettes per day in the past month
- FTND score of 2 or higher
- No severe respiratory diseases or serious cardiovascular and cerebrovascular diseases (controlled hypertension with SBP ≤ 160 mmHg and DBP ≤ 90 mmHg)
- Able and willing to provide informed consent
You will not qualify if you...
- History of alcoholism or long-term use of sedatives or analgesics
- Psychiatric or nervous system diseases such as Parkinson's disease, depression, schizophrenia, or severe audio-visual dysfunction before surgery
- Preoperative systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg
- Conversion to thoracotomy during thoracoscopic surgery
- Transfer to intensive care unit after surgery
- Refusal to use analgesic pump treatment or improper analgesic pump configuration
- Self-removal of patches or hospital stay shorter than 48 hours postoperatively
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 days surrounding surgery
Participants receive a nicotine patch or placebo patch starting 24 hours before thoracic surgery and continuing for 48 hours after surgery.
1 baseline visit before surgery and daily patch application through 48 hours after surgery
Trial Site Locations
Total: 1 location
1
Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan
Zhengzhou, Henan, China, 450003
Actively Recruiting
Research Team
W
Wei Li
J
Jiaqiang Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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