Trial Outcomes & Findings for Nicotine Patch as an Analgesic Adjuvant After Surgery (NCT NCT00440830)

NCT ID: NCT00440830

Last Updated: 2021-10-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 68 participants
• Primary outcome timeframe: 1 hour after surgery
• Results posted on: 2021-10-21

Participant Flow

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

Participant milestones

Measure	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.	Smokers-placebo Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	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.	Non-smokers-placebo Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Overall Study STARTED	20	8	30	10
Overall Study COMPLETED	20	8	30	10
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nicotine Patch as an Analgesic Adjuvant After Surgery

Baseline characteristics by cohort

Measure	Smokers-nicotine n=20 Participants 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.	Smokers-placebo n=8 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	Non-smokers-nicotine n=30 Participants 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.	Non-smokers-placebo n=10 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	8 Participants n=7 Participants	30 Participants n=5 Participants	10 Participants n=4 Participants	68 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	46 years STANDARD_DEVIATION 2 • n=5 Participants	43 years STANDARD_DEVIATION 4 • n=7 Participants	48 years STANDARD_DEVIATION 3 • n=5 Participants	52 years STANDARD_DEVIATION 4 • n=4 Participants	47 years STANDARD_DEVIATION 3 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants	5 Participants n=4 Participants	42 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants	5 Participants n=4 Participants	26 Participants n=21 Participants
Region of Enrollment United States	20 participants n=5 Participants	8 participants n=7 Participants	30 participants n=5 Participants	10 participants n=4 Participants	68 participants n=21 Participants

PRIMARY outcome

Timeframe: 1 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.

Outcome measures

Measure	Smokers-nicotine n=20 Participants 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.	Smokers-placebo n=8 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	Non-smokers-nicotine n=30 Participants 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.	Non-smokers-placebo n=10 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Postoperative Pain Score One Hour After Surgery	5.78 score on a scale Standard Deviation 1.80	5.17 score on a scale Standard Deviation 1.94	4.32 score on a scale Standard Deviation 1.78	5.60 score on a scale Standard Deviation 1.51

PRIMARY outcome

Timeframe: 5 days

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

Outcome measures

Measure	Smokers-nicotine n=20 Participants 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.	Smokers-placebo n=8 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	Non-smokers-nicotine n=30 Participants 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.	Non-smokers-placebo n=10 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Postoperative Pain Score Five Days After Surgery	2.24 score on a scale Standard Deviation 2.36	3.25 score on a scale Standard Deviation 2.31	1.38 score on a scale Standard Deviation 1.08	2.70 score on a scale Standard Deviation 1.49

SECONDARY outcome

Timeframe: 1 hour after surgery

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

Outcome measures

Measure	Smokers-nicotine n=20 Participants 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.	Smokers-placebo n=30 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	Non-smokers-nicotine n=8 Participants 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.	Non-smokers-placebo n=10 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Nausea Assessment by Patient	0 score on a scale Standard Deviation 0	2.1 score on a scale Standard Deviation 1.0	0 score on a scale Standard Deviation 0	2.4 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 5 days

Pain medication used after surgery in morphine equivalents

Outcome measures

Measure	Smokers-nicotine n=20 Participants 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.	Smokers-placebo n=8 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	Non-smokers-nicotine n=30 Participants 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.	Non-smokers-placebo n=10 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Pain Medication Used	75.2 Morphine equivalents Standard Deviation 10.7	82.0 Morphine equivalents Standard Deviation 22.9	41.9 Morphine equivalents Standard Deviation 11.2	35.7 Morphine equivalents Standard Deviation 10.5

SECONDARY outcome

Timeframe: 1 hour after surgery

Systolic blood pressure reported in Millimeters of Mercury (mmHg)

Outcome measures

Measure	Smokers-nicotine n=20 Participants 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.	Smokers-placebo n=8 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	Non-smokers-nicotine n=30 Participants 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.	Non-smokers-placebo n=10 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Systolic Blood Pressure	131 Millimeters of Mercury (mmHg) Standard Deviation 21	127 Millimeters of Mercury (mmHg) Standard Deviation 28	130 Millimeters of Mercury (mmHg) Standard Deviation 11	136 Millimeters of Mercury (mmHg) Standard Deviation 21

SECONDARY outcome

Timeframe: 1 hour after surgery

Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

Outcome measures

Measure	Smokers-nicotine n=20 Participants 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.	Smokers-placebo n=8 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	Non-smokers-nicotine n=30 Participants 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.	Non-smokers-placebo n=10 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Diastolic Blood Pressure	66 Millimeters of Mercury (mmHg) Standard Deviation 10.4	80 Millimeters of Mercury (mmHg) Standard Deviation 12	72 Millimeters of Mercury (mmHg) Standard Deviation 23	65 Millimeters of Mercury (mmHg) Standard Deviation 28

SECONDARY outcome

Timeframe: 1 hour after surgery

Heart rate reported in Beats per minute (BPM)

Outcome measures

Measure	Smokers-nicotine n=20 Participants 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.	Smokers-placebo n=8 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	Non-smokers-nicotine n=30 Participants 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.	Non-smokers-placebo n=10 Participants Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Heart Rate	74 Beats per minute (BPM) Standard Deviation 12	83 Beats per minute (BPM) Standard Deviation 16	72 Beats per minute (BPM) Standard Deviation 11	78 Beats per minute (BPM) Standard Deviation 14

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 hour after surgery

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

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

Outcome measures

Outcome data not reported

Adverse Events

Smokers-nicotine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smokers-placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-smokers-nicotine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-smokers-placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pamela Flood, MD

Columbia University

Phone: 212-305-2008

Email: pdf3@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place