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Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study
Plain-language guide to NCT07250230: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 80 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07250230
- Phase
- not phased
- Status
- recruiting participants
- Start
- 2025-11-30
- Completion (planned or actual)
- 2026-12-31
- Participants
- 80 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Nicotine Dependence; Thoracic Diseases; Analgesia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).
It had two arms (groups): Nicotine patch group (group N) (experimental) and 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.
The registry classes the interventions as drug.
Who Took Part
The registry lists 80 planned participants were the target.
It was open to men only aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could 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;. Obtain informed consent.
The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: 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;.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.
The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2025-11-30 with completion listed for 2026-12-31.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 80 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.
Our Notes on the Compound
Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.