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Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal 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: NCT00790829
Recruitment Status : Unknown
Verified August 2011 by Stony Brook University.
Recruitment status was:  Recruiting
First Posted : November 14, 2008
Last Update Posted : August 12, 2011
Sponsor:
Information provided by:
Stony Brook University

Study Description
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Brief Summary:
The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its effect on decreasing pain after surgery is the main purpose of the study.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: transdermal nicotine patch Not Applicable

Detailed Description:

Study patients include nonsmokers aged 18-75 undergoing open abdominal wall surgery under general anesthesia. If the patient smokes, receives a regional anesthetic such as an epidural, or is pregnant, then he/she is excluded from the study. There are two randomized study groups. Group B receives a seven-milligram transdermal patch and Group A receives a placebo patch. Generic seven-milligram nicotine patches or identical placebo patches made from band-aids are glued to a 3x4 inch adhesive pad and placed on the individuals' right upper arm 1 hour before surgery. All patients are given a standardized anesthetic consisting of a narcotic infusion, propofol, a neuromuscular blocking agent, anesthetic gas agent, antinauseant medication and a nonsteroidal.

Patients receive postoperative analgesia for twenty four hours after surgery with a narcotic or an additional nonsteroidal medication. All patients receive intravenous controlled patient controlled analgesia (IVPCA) with morphine sulfate one milligram per ten minutes, forty milligram four hour limit. Patients also receive toradol fifteen milligrams for breakthrough pain. The patch is removed from participants twenty four hours post IVPCA initiation. The following items are assessed every four hours for twenty four hours after post anesthesia care unit discharge: a verbal rating of pain, total IVPCA morphine use, nausea occurrence, vomiting occurrence, and sedation score by the nurse.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Preemptive Use of Nicotine Patch for Postoperative Pain Relief in Open Abdominal Surgery
Study Start Date : August 2007
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A, B
Group B received a seven-milligram transdermal patch and Group A received a placebo patch.
 Drug: transdermal nicotine patch
Generic seven-milligram nicotine patches for 24hours, placebo patch for 24 hours
Other Name: Generic


Outcome Measures
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Primary Outcome Measures :
  1. The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its effect on decreasing pain after surgery is the main purpose of the study. [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study patients include nonsmokers aged 18-75 undergoing open abdominal wall surgery under general anesthesia.

Exclusion Criteria:

  • If the patient smokes, receives a regional anesthetic such as an epidural, or is pregnant, then he/she is excluded from the study.
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): NCT00790829


Contacts
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Contact: Ursula N Landman, DO 631-444-2975 ulandman@notes.cc.sunysb.edu

Locations
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United States, New York
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Judy Matuk    631-632-9036    jmatuk@notes.cc.sunysb.edu   
Contact: Ursula N Landman, DO    631-444-2975    ulandman@notes.cc.sunysb.edu   
Principal Investigator: Ursula N Landman, DO         
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Ursula N Landman, DO Stony Brook University Hospital
More Information
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Responsible Party: Ursula N. Landman, D.O./Principal Investigator, SUNY Stony Brook
ClinicalTrials.gov Identifier: NCT00790829    
Other Study ID Numbers: 20075594
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011
Keywords provided by Stony Brook University:
preemptive
Nicotine Patch
Open Abdominal Surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
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