Nicotine DependenceNCT07250230
Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study
A study testing Nicotine patch in people with Nicotine Dependence and Thoracic Diseases, run by Henan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Nicotine Dependence, Thoracic Diseases, Analgesia
- What is being tested?
- Nicotine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- No severe respiratory diseases, no serious cardiovascular and cerebrovascular diseases (hypertension is treated with SBP ≤ 160mmHg, DBP ≤ 90mmHg after systemic treatment);
- Obtain informed consent.
Who cannot join
- 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
- Patients who are transferred to the intensive care unit after surgery;
- Patients who refuse to use analgesic pump treatment/do not configure the analgesic pump according to regulations;
- Patients who have self-removed patches/short hospital stay resulting in a postoperative observation time of < 48 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan
Zhengzhou, Henan, 450003
Wei Li, +8619838263779, 1131691709@qq.com
Jiaqiang Zhang, +8613937121360, zhangjiq@zzu.edu.cn
About this 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.
- Conditions
- Nicotine Dependence, Thoracic Diseases, Analgesia
- Being tested
- Nicotine patch
- Medical subject headings
- Tobacco Use Disorder, Thoracic Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Nicotine patch group (group N) | Experimental | 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) Receives: Drug: Nicotine patch |
| Control group (Group C) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Analgesic pump dosage in (ml) for Postoperative pain
Analgesic pump dosage at 1, 6, 24, 48 hours postoperative operation (ml)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start30 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiaqiang Zhang, PHD, Study chair, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250230
- Sponsor's protocol ID
- meinihaokan
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07250230
- Acronym / sponsor ID
- meinihaokan
- Conditions
- Nicotine Dependence, Thoracic Diseases, Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine patch group (group N) | Experimental | Drug: Nicotine patchBased 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) | No intervention | –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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- No severe respiratory diseases, no serious cardiovascular and cerebrovascular diseases (hypertension is treated with SBP ≤ 160mmHg, DBP ≤ 90mmHg after systemic treatment);
Key exclusion criteria (7 listed)
- 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
- Patients who are transferred to the intensive care unit after surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patchBased 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 group (group N) |
Primary outcome
Analgesic pump dosage in (ml) for Postoperative pain
Time frame: 48 hours
Analgesic pump dosage at 1, 6, 24, 48 hours postoperative operation (ml)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiaqiang Zhang, PHD study chair
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patch in people with Nicotine Dependence and Thoracic Diseases, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Li (+8619838263779, 1131691709@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic pump dosage in (ml) for Postoperative pain (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.