Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preemptive Use of Nicotine Patch for Postoperative Pain Relief in Open Abdominal Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: transdermal nicotine patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A, B<br>Group B received a seven-milligram transdermal patch and Group A received a placebo patch. | Drug: transdermal nicotine patch<br>* Generic seven-milligram nicotine patches for 24hours, placebo patch for 24 hours<br>* Other names: Generic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preemptive, Nicotine Patch, Open Abdominal Surgery