Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study

Globally, approximately 230 million adults undergo surgical procedures each year, with around 30% of patients maintaining smoking habits prior to surgery. Extensive clinical research has confirmed that tobacco exposure is a significant independent risk factor for perioperative complications. Epidemiological data indicate that long-term smokers experience a significantly higher all-cause mortality rate during hospitalization, approximately 20% greater than non-smokers, while the incidence of postoperative complications is 40% higher. Consequently, international guidelines universally recommend the establishment of standardized preoperative smoking cessation programs for surgical patients. Nicotine withdrawal, a typical clinical manifestation during smoking cessation, involves symptoms across multiple systems: neuropsychiatric symptoms such as mood depression, sleep disturbances, and irritability; autonomic dysfunction leading to postural dizziness and bradycardia; and metabolic dysregulation resulting in increased appetite and weight gain. Notably, these withdrawal symptoms exhibit a significant time-dependent pattern, typically peaking 24-72 hours after cessation. Multicenter studies have demonstrated that tobacco-dependent patients experience an average increase of IV Abstract 35-45% in opioid consumption within 24 hours postoperatively, with the duration of analgesic requirements extended by approximately 25%. However, some patients suffer from severe adverse reactions to opioids (e.g., nausea, vomiting, confusion), making the use of adjuvant medications for multimodal analgesia and optimized pain management particularly crucial. By the late 20th century, the analgesic properties of nicotine, a primary component of tobacco, were systematically studied and applied in clinical practice.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Thoracic Diseases; Nicotine Dependence
• Intervention / Treatment: Drug: Nicotine patch

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiaqiang Zhang; Phone Number: +8613937121360; Email: jiaqiang197628@163.com
• Study Contact Backup: Name: Wei Li; Phone Number: +8619838263779; Email: 1131691709@qq.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan
      • Contact: Wei Li; Phone Number: +8619838263779; Email: 1131691709@qq.com
      • Contact: Jiaqiang Zhang; Phone Number: +8613937121360; Email: zhangjiq@zzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nicotine patch group (group N); Based on analgesia in the control group, the patients were given a nicotine patch every day, 24 hours before surgery and 48 hours after surgery, placed on the patient's arm, chest, or back, and the skin was cleaned before the patch. Different doses of nicotine patches are given depending on the number of cigarettes smoked by the patient (one 21 mg patch for every 20 cigarettes, 42 mg patch for patients who smoke ≥ 40 cigarettes per day)	Drug: Nicotine patch; Based on analgesia in the control group, the patients were given a nicotine patch every day, 24 hours before surgery and 48 hours after surgery, placed on the patient's arm, chest, or back, and the skin was cleaned before the patch. Different doses of nicotine patches are given depending on the number of cigarettes smoked by the patient (one 21 mg patch for every 20 cigarettes, 42 mg patch for patients who smoke ≥ 40 cigarettes per day)
No Intervention: Control group (Group C); On the basis of conventional analgesia, patients were given a placebo patch without any drug effect every day 24 hours before surgery and 48 hours after surgery, and the shape, weight, and position of the patch were consistent with those of the experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic pump dosage in (ml) for Postoperative pain	Analgesic pump dosage at 1, 6, 24, 48 hours postoperative operation (ml)	48 hours

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital
• Investigators: Study Chair: Jiaqiang Zhang, PHD, Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 7, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Respiratory Tract Diseases; Neurobehavioral Manifestations; Substance-Related Disorders; Chemically-Induced Disorders; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tobacco Use Disorder; Agnosia; Thoracic Diseases; Therapeutics; Tobacco Use Cessation Devices
• Other Study ID Numbers: meinihaokan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No