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

Current Smokers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266212
• Other study ID #: VGHKS101-016
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Current Smokers
• Never Smokers
• Past Smokers

Intervention

Procedure:
• 5 ml arterial blood
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).

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Morphine consumption	Differences in postoperative morphine consumption between the 3 groups	Post-operation Day1 to Day4
Other	side effects	site effects include dizzy, vomit, lethargic sleep and pruritus	Post-operation Day1 to Day4
Primary	Fagerstrom test for nicotine dependence		Post-operation Day1 to Day4
Secondary	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