Nicotine Patch as an Analgesic Adjuvant After Surgery

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00440830
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 4
• Duration (Months): 36
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: nicotine patch; Drug: nicotine patch; Drug: placebo; Drug: placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Study to Determine Whether the Use of a Nicotine Patch During the Day of Surgery Improves Postoperative Pain and Reduces Opioid Requirement
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Smokers-nicotine Smokers who were treated with nicotine	Drug: nicotine patch; nicotine patch (0,5,10 or 15mg/day) applied to smokers; Other Names: nicotrol
Experimental: Nonsmokers-nicotine Nonsmokers who were treated with nicotine	Drug: nicotine patch; nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers; Other Names: nicotrol
Placebo Comparator: Smokers-placebo Smokers who were treated with placebo	Drug: placebo; placebo patch applied to smokers
Placebo Comparator: Nonsmokers-placebo Nonsmokers who were treated with placebo	Drug: placebo; placebo patch applied to nonsmokers

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain Score One Hour After Surgery [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.

2. Postoperative Pain Score Five Days After Surgery [5 days]

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

Secondary Outcome Measures

1. Nausea Assessment by Patient [1 hour after surgery]

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

2. Pain Medication Used [5 days]

   Pain medication used after surgery in morphine equivalents

3. Systolic Blood Pressure [1 hour after surgery]

   Systolic blood pressure reported in Millimeters of Mercury (mmHg)

4. Diastolic Blood Pressure [1 hour after surgery]

   Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

5. Heart Rate [1 hour after surgery]

   Heart rate reported in Beats per minute (BPM)

Other Outcome Measures

1. Sedation Level [1 hour after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult ASA 1-2

Exclusion Criteria:

• Cardiovascular disease

• Former smoker

• Pregnant

• Nursing

• Asthma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Irving Medical Center / New York Presbyterian	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Pamela Flood, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT00440830
• Other Study ID Numbers: AAAB5945
• First Posted: Feb 27, 2007
• Last Update Posted: Oct 21, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Columbia University: acute pain; nicotine; nausea; sedation
• Additional relevant MeSH terms: Nicotine

Study Results

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.

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

Baseline Characteristics

Arm/Group Title	Smokers-nicotine	Smokers-placebo	Non-smokers-nicotine	Non-smokers-placebo	Total
Arm/Group Description	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.	Total of all reporting groups
Overall Participants	20	8	30	10	68
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	8 100%	30 100%	10 100%	68 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (2)	43 (4)	48 (3)	52 (4)	47 (3)
Sex: Female, Male (Count of Participants)
Female	17 85%	5 62.5%	15 50%	5 50%	42 61.8%
Male	3 15%	3 37.5%	15 50%	5 50%	26 38.2%
Region of Enrollment (participants) [Number]
United States	20 100%	8 100%	30 100%	10 100%	68 100%

Outcome Measures

1. Primary Outcome

Title	Postoperative Pain Score One Hour After Surgery
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smokers-nicotine	Smokers-placebo	Non-smokers-nicotine	Non-smokers-placebo
Arm/Group Description	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Measure Participants	20	8	30	10
Mean (Standard Deviation) [score on a scale]	5.78 (1.80)	5.17 (1.94)	4.32 (1.78)	5.60 (1.51)

2. Primary Outcome

Title	Postoperative Pain Score Five Days After Surgery
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smokers-nicotine	Smokers-placebo	Non-smokers-nicotine	Non-smokers-placebo
Arm/Group Description	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Measure Participants	20	8	30	10
Mean (Standard Deviation) [score on a scale]	2.24 (2.36)	3.25 (2.31)	1.38 (1.08)	2.70 (1.49)

3. Secondary Outcome

Title	Nausea Assessment by Patient
Description	Nausea scale range: 0=none and 10=the worst, ordinal.
Time Frame	1 hour after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smokers-nicotine	Nonsmokers-nicotine	Smokers-placebo	Nonsmokers-placebo
Arm/Group Description	Smokers who were treated with nicotine nicotine patch: nicotine patch (0,5,10 or 15mg/day) applied to smokers	Nonsmokers who were treated with nicotine nicotine patch: nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers	Smokers who were treated with placebo placebo: placebo patch applied to smokers	Nonsmokers who were treated with placebo placebo: placebo patch applied to nonsmokers
Measure Participants	20	30	8	10
Mean (Standard Deviation) [score on a scale]	0 (0)	2.1 (1.0)	0 (0)	2.4 (2.0)

4. Secondary Outcome

Title	Pain Medication Used
Description	Pain medication used after surgery in morphine equivalents
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smokers-nicotine	Smokers-placebo	Non-smokers-nicotine	Non-smokers-placebo
Arm/Group Description	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Measure Participants	20	8	30	10
Mean (Standard Deviation) [Morphine equivalents]	75.2 (10.7)	82.0 (22.9)	41.9 (11.2)	35.7 (10.5)

5. Secondary Outcome

Title	Systolic Blood Pressure
Description	Systolic blood pressure reported in Millimeters of Mercury (mmHg)
Time Frame	1 hour after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smokers-nicotine	Smokers-placebo	Non-smokers-nicotine	Non-smokers-placebo
Arm/Group Description	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Measure Participants	20	8	30	10
Mean (Standard Deviation) [Millimeters of Mercury (mmHg)]	131 (21)	127 (28)	130 (11)	136 (21)

6. Secondary Outcome

Title	Diastolic Blood Pressure
Description	Diastolic blood pressure reported in Millimeters of Mercury (mmHg)
Time Frame	1 hour after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smokers-nicotine	Smokers-placebo	Non-smokers-nicotine	Non-smokers-placebo
Arm/Group Description	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.	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.	Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
Measure Participants	20	8	30	10
Mean (Standard Deviation) [Millimeters of Mercury (mmHg)]	66 (10.4)	80 (12)	72 (23)	65 (28)

7. Secondary Outcome

Title	Heart Rate
Description	Heart rate reported in Beats per minute (BPM)
Time Frame	1 hour after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

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

8. Other Pre-specified Outcome

Title	Sedation Level
Description	Sedation may be monitored for the first hour, at the time of other data collection.
Time Frame	1 hour after surgery

Outcome Measure Data

Analysis Population Description

Data was not collected or analyzed for this measure.

Arm/Group Title	Smokers-nicotine	Nonsmokers-nicotine	Smokers-placebo	Nonsmokers-placebo
Arm/Group Description	Smokers who were treated with nicotine nicotine patch: nicotine patch (0,5,10 or 15mg/day) applied to smokers	Nonsmokers who were treated with nicotine nicotine patch: nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers	Smokers who were treated with placebo placebo: placebo patch applied to smokers	Nonsmokers who were treated with placebo placebo: placebo patch applied to nonsmokers
Measure Participants	0	0	0	0

Adverse Events

Arm/Group Title	Smokers-nicotine		Smokers-placebo		Non-smokers-nicotine		Non-smokers-placebo
Arm/Group Description	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.		Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.		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.		Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
All Cause Mortality
	Smokers-nicotine		Smokers-placebo		Non-smokers-nicotine		Non-smokers-placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Smokers-nicotine		Smokers-placebo		Non-smokers-nicotine		Non-smokers-placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/8 (0%)		0/30 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Smokers-nicotine		Smokers-placebo		Non-smokers-nicotine		Non-smokers-placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/8 (0%)		0/30 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.