PainPhase 4NCT00440830

Nicotine Patch as an Analgesic Adjuvant After Surgery

A Phase 4 study testing nicotine patch in people with Pain, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Effect of nicotine patch as an adjutant for acute pain after surgery. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Pain
What is being tested?: nicotine patch
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteUnited States
Study dates: Dec 2005to Dec 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Adult ASA 1-2

Who cannot join

Cardiovascular disease
Former smoker
Pregnant
Nursing
Asthma

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Irving Medical Center / New York Presbyterian
New York, New York, 10032

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Pain
Being tested: nicotine patch, placebo
Keywords: acute pain, nicotine, nausea, sedation
Medical subject headings: Pain, Acute Pain, Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nicotine patchDrug
Also called nicotrol
nicotine patch (0,5,10 or 15mg/day) applied to smokers
nicotine patchDrug
Also called nicotrol
nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers
placeboDrug
placebo patch applied to smokers
placeboDrug
placebo patch applied to nonsmokers

Study groups in NCT00440830
Study group	Role	What they receive
Smokers-nicotine	Experimental	Smokers who were treated with nicotine Receives: Drug: nicotine patch
Nonsmokers-nicotine	Experimental	Nonsmokers who were treated with nicotine Receives: Drug: nicotine patch
Smokers-placebo	Placebo comparator	Smokers who were treated with placebo Receives: Drug: placebo
Nonsmokers-placebo	Placebo comparator	Nonsmokers who were treated with placebo Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 hour after surgery
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.
Measured: 5 days

Secondary outcomes (5)

Nausea Assessment by Patient
Nausea scale range: 0=none and 10=the worst, ordinal.
Measured: 1 hour after surgery
Pain Medication Used
Pain medication used after surgery in morphine equivalents
Measured: 5 days
Systolic Blood Pressure
Systolic blood pressure reported in Millimeters of Mercury (mmHg)
Measured: 1 hour after surgery
Diastolic Blood Pressure
Diastolic blood pressure reported in Millimeters of Mercury (mmHg)
Measured: 1 hour after surgery
Heart Rate
Heart rate reported in Beats per minute (BPM)
Measured: 1 hour after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Dec 2008

First posted27 Feb 2007 (estimated)
Study startDec 2005
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00440830
Sponsor's protocol ID: AAAB5945
Status last verified: Sep 2021
First submitted: 26 Feb 2007
Last updated: 21 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Olson LC, Hong D, Conell-Price JS, Cheng S, Flood P. A transdermal nicotine patch is not effective for postoperative pain management in smokers: a pilot dose-ranging study. Anesth Analg. 2009 Dec;109(6):1987-91. doi: 10.1213/ANE.0b013e3181bd1612.
PubMed 19923530
Hong D, Conell-Price J, Cheng S, Flood P. Transdermal nicotine patch for postoperative pain management: a pilot dose-ranging study. Anesth Analg. 2008 Sep;107(3):1005-10. doi: 10.1213/ane.0b013e318163204f.
PubMed 18713921

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Determine Whether the Use of a Nicotine Patch During the Day of Surgery Improves Postoperative Pain and Reduces Opioid Requirement
ClinicalTrials.gov ID: NCT00440830
Acronym / sponsor ID: AAAB5945
Conditions: Pain
Keywords: acute pain, nicotine, nausea, sedation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: Dec 2005
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 27 Feb 2007 (estimated)
Results: Posted 27 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Smokers-nicotine	Experimental	Drug: nicotine patchSmokers who were treated with nicotine
Nonsmokers-nicotine	Experimental	Drug: nicotine patchNonsmokers who were treated with nicotine
Smokers-placebo	Placebo comparator	Drug: placeboSmokers who were treated with placebo
Nonsmokers-placebo	Placebo comparator	Drug: placeboNonsmokers who were treated with placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Adult ASA 1-2

Key exclusion criteria (5 listed)

Cardiovascular disease
Former smoker
Pregnant
Nursing
Asthma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nicotine patchAlso: nicotrolnicotine patch (0,5,10 or 15mg/day) applied to smokers	Drug	Smokers-nicotine
nicotine patchAlso: nicotrolnicotine patch (0,5,10,or 15mg/day) applied to nonsmokers	Drug	Nonsmokers-nicotine
placeboplacebo patch applied to smokers	Drug	Smokers-placebo
placeboplacebo patch applied to nonsmokers	Drug	Nonsmokers-placebo

Primary outcome

Postoperative Pain Score One Hour After Surgery
Time frame: 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.
Postoperative Pain Score Five Days After Surgery
Time frame: 5 days
Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.

5 secondary outcomes

Nausea Assessment by Patient
Time frame: 1 hour after surgery
Pain Medication Used
Time frame: 5 days
Systolic Blood Pressure
Time frame: 1 hour after surgery
Diastolic Blood Pressure
Time frame: 1 hour after surgery
Heart Rate
Time frame: 1 hour after surgery

Results and safety

Results posted to the registry on 27 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Smokers-nicotine	20	20
Smokers-placebo	8	8
Non-smokers-nicotine	30	30
Non-smokers-placebo	10	10

Primary outcome: Postoperative Pain Score One Hour After Surgery

Time frame: 1 hour after surgery. Mean (Standard Deviation). Unit: score on a scale

Measure	Smokers-nicotine n = 20	Smokers-placebo n = 8	Non-smokers-nicotine n = 30	Non-smokers-placebo n = 10
Value	5.78 (1.80)	5.17 (1.94)	4.32 (1.78)	5.60 (1.51)

Primary outcome: Postoperative Pain Score Five Days After Surgery

Time frame: 5 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Smokers-nicotine n = 20	Smokers-placebo n = 8	Non-smokers-nicotine n = 30	Non-smokers-placebo n = 10
Value	2.24 (2.36)	3.25 (2.31)	1.38 (1.08)	2.70 (1.49)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Smokers-nicotine	0 of 20 (0%)	0 of 20 (0%)	Not reported
Smokers-placebo	0 of 8 (0%)	0 of 8 (0%)	Not reported
Non-smokers-nicotine	0 of 30 (0%)	0 of 30 (0%)	Not reported
Non-smokers-placebo	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19923530Olson LC, Hong D, Conell-Price JS, Cheng S, Flood P. A transdermal nicotine patch is not effective for postoperative pain management in smokers: a pilot dose-ranging study. Anesth Analg. 2009 Dec;109(6):1987-91. doi: 10.1213/ANE.0b013e3181bd1612.
Results publication: PubMed 18713921Hong D, Conell-Price J, Cheng S, Flood P. Transdermal nicotine patch for postoperative pain management: a pilot dose-ranging study. Anesth Analg. 2008 Sep;107(3):1005-10. doi: 10.1213/ane.0b013e318163204f.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela Flood, MD principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing nicotine patch in people with Pain, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Score One Hour After Surgery (time frame: 1 hour after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00440830, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.