A Study on Analgesia and Related Outcomes for Patients With Tabacco Smoking

Study Overview
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Brief Summary
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Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among current, past and non smokers are determined by comparing and analyzing frequency distributions. To determine whether smokers require more post operative opiate analgesics than others. Multivariate analysis will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. Our previous related study showed that the smoker male patients consumed more analgesics than those without smoking, but the female group showed the similar findings. However, the case number, especially the female cases, is underpowered. Investigators hope to increase the case number to have a better statistical and clinical significance.

Official Title
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The Implications of Tobacco Smoking on Acute Postoperative Pain: A Prospective Observational Study

Conditions
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Current Smokers, Past Smokers, Never Smokers

Intervention / Treatment
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* Procedure: 5 ml arterial blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective general surgery are assigned to current smokers（n=100） or past smokers（n=100） or never smokers（n=100） according to the questionnaires Fagerstrom test for nicotine dependence 1 day prior to the surgery. Exclusion Criteria: the patients undergoing major thoracic cardiovascular surgery the patients with significant lung lesion the patients with conscious disturbance the patients with allergic history to morphine

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Smoke<br>Fagerstrom test for nicotine dependence | Procedure: 5 ml arterial blood<br>* A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).<br>|
| Active Comparator: Pain<br>pain during post-operation Day1 to Day4 | Procedure: 5 ml arterial blood<br>* A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).<br>|
| Active Comparator: Morphine<br>Morphine consumption during post-operation Day1 to Day4 | Procedure: 5 ml arterial blood<br>* A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fagerstrom test for nicotine dependence |  | Post-operation Day1 to Day4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in pain intensity between the three groups after postoperative analgesia. | Patients will give a pain score from 0 to 10. 10 is the most painful score. | Post-operation Day1 to Day4 |