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Nicotine Patch as an Analgesic Adjuvant After Surgery

Study to Determine Whether the Use of a Nicotine Patch During the Day of Surgery Improves Postoperative Pain and Reduces Opioid Requirement

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00440830
Enrollment
68
Registered
2007-02-27
Start date
2005-12-31
Completion date
2008-12-31
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

acute pain, nicotine, nausea, sedation

Brief summary

Effect of nicotine patch as an adjutant for acute pain after surgery.

Detailed description

This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.

Interventions

DRUGnicotine patch

nicotine patch (0,5,10 or 15mg/day) applied to smokers

DRUGplacebo

placebo patch applied to smokers

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Adult ASA 1-2

Exclusion criteria

* Cardiovascular disease * Former smoker * Pregnant * Nursing * Asthma

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Score Five Days After Surgery5 daysPostoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.
Postoperative Pain Score One Hour After Surgery1 hour after surgeryPostoperative pain reported after the first hour using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.

Secondary

MeasureTime frameDescription
Pain Medication Used5 daysPain medication used after surgery in morphine equivalents
Systolic Blood Pressure1 hour after surgerySystolic blood pressure reported in Millimeters of Mercury (mmHg)
Heart Rate1 hour after surgeryHeart rate reported in Beats per minute (BPM)
Diastolic Blood Pressure1 hour after surgeryDiastolic blood pressure reported in Millimeters of Mercury (mmHg)
Nausea Assessment by Patient1 hour after surgeryNausea scale range: 0=none and 10=the worst, ordinal.

Other

MeasureTime frameDescription
Sedation Level1 hour after surgerySedation may be monitored for the first hour, at the time of other data collection.

Countries

United States

Participant flow

Recruitment details

This prospective, double-blind trial was approved by the IRB at Columbia University Medical Center. All patients signed written informed consent before surgery.

Participants by arm

ArmCount
Smokers-nicotine
Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
20
Smokers-placebo
Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
8
Non-smokers-nicotine
Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
30
Non-smokers-placebo
Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
10
Total68

Baseline characteristics

CharacteristicSmokers-placeboNon-smokers-nicotineSmokers-nicotineNon-smokers-placeboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
8 Participants30 Participants20 Participants10 Participants68 Participants
Age, Continuous43 years
STANDARD_DEVIATION 4
48 years
STANDARD_DEVIATION 3
46 years
STANDARD_DEVIATION 2
52 years
STANDARD_DEVIATION 4
47 years
STANDARD_DEVIATION 3
Region of Enrollment
United States
8 participants30 participants20 participants10 participants68 participants
Sex: Female, Male
Female
5 Participants15 Participants17 Participants5 Participants42 Participants
Sex: Female, Male
Male
3 Participants15 Participants3 Participants5 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 200 / 80 / 300 / 10
serious
Total, serious adverse events
0 / 200 / 80 / 300 / 10

Outcome results

Primary

Postoperative Pain Score Five Days After Surgery

Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.

Time frame: 5 days

ArmMeasureValue (MEAN)Dispersion
Smokers-nicotinePostoperative Pain Score Five Days After Surgery2.24 score on a scaleStandard Deviation 2.36
Smokers-placeboPostoperative Pain Score Five Days After Surgery3.25 score on a scaleStandard Deviation 2.31
Non-smokers-nicotinePostoperative Pain Score Five Days After Surgery1.38 score on a scaleStandard Deviation 1.08
Non-smokers-placeboPostoperative Pain Score Five Days After Surgery2.70 score on a scaleStandard Deviation 1.49
Primary

Postoperative Pain Score One Hour After Surgery

Postoperative pain reported after the first hour using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.

Time frame: 1 hour after surgery

ArmMeasureValue (MEAN)Dispersion
Smokers-nicotinePostoperative Pain Score One Hour After Surgery5.78 score on a scaleStandard Deviation 1.8
Smokers-placeboPostoperative Pain Score One Hour After Surgery5.17 score on a scaleStandard Deviation 1.94
Non-smokers-nicotinePostoperative Pain Score One Hour After Surgery4.32 score on a scaleStandard Deviation 1.78
Non-smokers-placeboPostoperative Pain Score One Hour After Surgery5.60 score on a scaleStandard Deviation 1.51
Secondary

Diastolic Blood Pressure

Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

Time frame: 1 hour after surgery

ArmMeasureValue (MEAN)Dispersion
Smokers-nicotineDiastolic Blood Pressure66 Millimeters of Mercury (mmHg)Standard Deviation 10.4
Smokers-placeboDiastolic Blood Pressure80 Millimeters of Mercury (mmHg)Standard Deviation 12
Non-smokers-nicotineDiastolic Blood Pressure72 Millimeters of Mercury (mmHg)Standard Deviation 23
Non-smokers-placeboDiastolic Blood Pressure65 Millimeters of Mercury (mmHg)Standard Deviation 28
Secondary

Heart Rate

Heart rate reported in Beats per minute (BPM)

Time frame: 1 hour after surgery

ArmMeasureValue (MEAN)Dispersion
Smokers-nicotineHeart Rate74 Beats per minute (BPM)Standard Deviation 12
Smokers-placeboHeart Rate83 Beats per minute (BPM)Standard Deviation 16
Non-smokers-nicotineHeart Rate72 Beats per minute (BPM)Standard Deviation 11
Non-smokers-placeboHeart Rate78 Beats per minute (BPM)Standard Deviation 14
Secondary

Nausea Assessment by Patient

Nausea scale range: 0=none and 10=the worst, ordinal.

Time frame: 1 hour after surgery

ArmMeasureValue (MEAN)Dispersion
Smokers-nicotineNausea Assessment by Patient0 score on a scaleStandard Deviation 0
Smokers-placeboNausea Assessment by Patient2.1 score on a scaleStandard Deviation 1
Non-smokers-nicotineNausea Assessment by Patient0 score on a scaleStandard Deviation 0
Non-smokers-placeboNausea Assessment by Patient2.4 score on a scaleStandard Deviation 2
Secondary

Pain Medication Used

Pain medication used after surgery in morphine equivalents

Time frame: 5 days

ArmMeasureValue (MEAN)Dispersion
Smokers-nicotinePain Medication Used75.2 Morphine equivalentsStandard Deviation 10.7
Smokers-placeboPain Medication Used82.0 Morphine equivalentsStandard Deviation 22.9
Non-smokers-nicotinePain Medication Used41.9 Morphine equivalentsStandard Deviation 11.2
Non-smokers-placeboPain Medication Used35.7 Morphine equivalentsStandard Deviation 10.5
Secondary

Systolic Blood Pressure

Systolic blood pressure reported in Millimeters of Mercury (mmHg)

Time frame: 1 hour after surgery

ArmMeasureValue (MEAN)Dispersion
Smokers-nicotineSystolic Blood Pressure131 Millimeters of Mercury (mmHg)Standard Deviation 21
Smokers-placeboSystolic Blood Pressure127 Millimeters of Mercury (mmHg)Standard Deviation 28
Non-smokers-nicotineSystolic Blood Pressure130 Millimeters of Mercury (mmHg)Standard Deviation 11
Non-smokers-placeboSystolic Blood Pressure136 Millimeters of Mercury (mmHg)Standard Deviation 21
Other Pre-specified

Sedation Level

Sedation may be monitored for the first hour, at the time of other data collection.

Time frame: 1 hour after surgery

Population: Data was not collected or analyzed for this measure.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026