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Nicotine Patch as an Analgesic Adjuvant After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00440830
Recruitment Status : Completed
First Posted : February 27, 2007
Results First Posted : October 27, 2010
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Columbia University

Study Description
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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: 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
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Study Type : Interventional  (Clinical Trial)
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 : December 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Nausea Assessment by Patient [ Time Frame: 1 hour after surgery ]
    Nausea scale range: 0=none and 10=the worst, ordinal.

  2. Pain Medication Used [ Time Frame: 5 days ]
    Pain medication used after surgery in morphine equivalents

  3. Systolic Blood Pressure [ Time Frame: 1 hour after surgery ]
    Systolic blood pressure reported in Millimeters of Mercury (mmHg)

  4. Diastolic Blood Pressure [ Time Frame: 1 hour after surgery ]
    Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

  5. Heart Rate [ Time Frame: 1 hour after surgery ]
    Heart rate reported in Beats per minute (BPM)


Other Outcome Measures:
  1. Sedation Level [ Time Frame: 1 hour after surgery ]
    Sedation may be monitored for the first hour, at the time of other data collection.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult ASA 1-2

Exclusion Criteria:

  • Cardiovascular disease
  • Former smoker
  • Pregnant
  • Nursing
  • Asthma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440830


Locations
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United States, New York
Columbia University Irving Medical Center / New York Presbyterian
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Pamela Flood, MD Columbia University
More Information
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Publications of Results:

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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00440830    
Other Study ID Numbers: AAAB5945
First Posted: February 27, 2007    Key Record Dates
Results First Posted: October 27, 2010
Last Update Posted: October 21, 2021
Last Verified: September 2021
Keywords provided by Columbia University:
acute pain
nicotine
nausea
sedation
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action