Nicotine Patch as an Analgesic Adjuvant After Surgery

Study Overview
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Brief Summary
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Effect of nicotine patch as an adjutant for acute pain after surgery.

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: nicotine patch
* Drug: nicotine patch
* Drug: placebo
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult ASA 1-2 Exclusion Criteria: Cardiovascular disease Former smoker Pregnant Nursing Asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smokers-nicotine<br>Smokers who were treated with nicotine | Drug: nicotine patch<br>* nicotine patch (0,5,10 or 15mg/day) applied to smokers<br>* Other names: nicotrol;|
| Experimental: Nonsmokers-nicotine<br>Nonsmokers who were treated with nicotine | Drug: nicotine patch<br>* nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers<br>* Other names: nicotrol;|
| Placebo Comparator: Smokers-placebo<br>Smokers who were treated with placebo | Drug: placebo<br>* placebo patch applied to smokers<br>|
| Placebo Comparator: Nonsmokers-placebo<br>Nonsmokers who were treated with placebo | Drug: placebo<br>* placebo patch applied to nonsmokers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 5 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pain, nicotine, nausea, sedation