Nicotine Patch as an Analgesic Adjuvant After Surgery

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00440830
First received: February 26, 2007
Last updated: October 29, 2010
Last verified: October 2010
Results First Received: October 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: nicotine patch
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This prospective, double-blind trial was approved by the IRB at Columbia University Medical Center. All patients signed written informed consent before surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Smokers-nicotine     Smokers-placebo     Non-smokers-nicotine     Non-smokers-placebo  
STARTED     20     8     30     10  
COMPLETED     20     8     30     10  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Smokers-nicotine     Smokers-placebo     Non-smokers-nicotine     Non-smokers-placebo     Total  
Number of Participants  
[units: participants]
  20     8     30     10     68  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     20     8     30     10     68  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46  ± 2     43  ± 4     48  ± 3     52  ± 4     47  ± 3  
Gender  
[units: participants]
         
Female     17     5     15     5     42  
Male     3     3     15     5     26  
Region of Enrollment  
[units: participants]
         
United States     20     8     30     10     68  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Postoperative Pain Score One Hour After Surgery   [ Time Frame: 1 hour after surgery ]

2.  Primary:   Postoperative Pain Score Five Days After Surgery   [ Time Frame: 5 days ]

3.  Secondary:   Nausea Assessment by Patient   [ Time Frame: 1 hour after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Sedation   [ Time Frame: 1 hour after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Pain Medication Used   [ Time Frame: 5 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Systolic Blood Pressure   [ Time Frame: 1 hour after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Diastolic Blood Pressure   [ Time Frame: 1 hour after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Heart Rate   [ Time Frame: 1 hour after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Pamela Flood, MD
Organization: Columbia University
phone: 212-305-2008
e-mail: pdf3@columbia.edu


Publications of Results:

Responsible Party: Pamela Flood, Columbia University
ClinicalTrials.gov Identifier: NCT00440830     History of Changes
Other Study ID Numbers: AAAB5945
Study First Received: February 26, 2007
Results First Received: October 1, 2010
Last Updated: October 29, 2010
Health Authority: United States: Food and Drug Administration