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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-75
SponsorHenan Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male, aged 18-75 years, with a body mass index (BMI) of 18-28 kg/m2 Between;

Thoracoscopic lobectomy/segmental/wedge resection under general anesthesia;

American Society of Anesthesiologists (ASA) classifications I-III Level;

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;

Disqualifiers

Those who have a history of alcoholism, long-term use of sedatives or analgesics;

Patients with psychiatric and nervous system diseases (such as Parkinson's, depression, schizophrenia) and severe audio-visual dysfunction before surgery;

Preoperative systolic blood pressure > 180mmHg or diastolic blood pressure > 110mmHg;

Patients who were converted to thoracotomy during thoracoscopic surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nicotine patch

    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)

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Nicotine patch group (group N)Experimental treatment 1 intervention
Group B: Control group (Group C)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Analgesic pump dosage in (ml) for Postoperative pain

Analgesic pump dosage at 1, 6, 24, 48 hours postoperative operation (ml)

Time frame
48 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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