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

January 20, 2026 updated by: Henan Provincial People's Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analgesic pump dosage in (ml) for Postoperative pain
Time Frame: 48 hours
Analgesic pump dosage at 1, 6, 24, 48 hours postoperative operation (ml)
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan Provincial People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jiaqiang Zhang, PHD, Henan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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