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

Not Applicable

Completed

• Conditions: Never Smokers; Past Smokers; Current Smokers
• Interventions: Procedure: 5 ml arterial blood

• Registration Number: NCT02266212
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-10-12
• Study First Posted: 2014-10-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Smoke	5 ml arterial blood	Fagerstrom test for nicotine dependence
Pain	5 ml arterial blood	pain during post-operation Day1 to Day4
Morphine	5 ml arterial blood	Morphine consumption during post-operation Day1 to Day4

Primary Outcome Measures

Name	Time	Method
Fagerstrom test for nicotine dependence	Post-operation Day1 to Day4

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan