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

NCT ID: NCT07250230

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Nicotine Dependence; Thoracic Diseases; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Nicotine patch

Intervention Type: DRUG

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)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiaqiang Zhang, PHD

Role: STUDY_CHAIR

Henan Provincial People's Hospital

Locations

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

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Li

Role: CONTACT

1131691709@qq.com

+8619838263779

Jiaqiang Zhang

Role: CONTACT

jiaqiang197628@163.com

+8613937121360

Facility Contacts

Wei Li

Role: primary

1131691709@qq.com

+8619838263779

Jiaqiang Zhang

Role: backup

zhangjiq@zzu.edu.cn

+8613937121360

Other Identifiers

meinihaokan

Identifier Type: -

Identifier Source: org_study_id