A Study on Analgesia and Related Outcomes for Patients With Tabacco Smoking
The Implications of Tobacco Smoking on Acute Postoperative Pain: A Prospective Observational Study
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
October 16, 2014
CompletedOctober 27, 2023
October 1, 2023
1 year
September 10, 2014
October 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Fagerstrom test for nicotine dependence
Post-operation Day1 to Day4
Secondary Outcomes (1)
Differences in pain intensity between the three groups after postoperative analgesia.
Post-operation Day1 to Day4
Other Outcomes (2)
Morphine consumption
Post-operation Day1 to Day4
side effects
Post-operation Day1 to Day4
Study Arms (3)
Smoke
ACTIVE COMPARATORFagerstrom test for nicotine dependence
Pain
ACTIVE COMPARATORpain during post-operation Day1 to Day4
Morphine
ACTIVE COMPARATORMorphine consumption during post-operation Day1 to Day4
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- anesthesia doctor
Study Record Dates
First Submitted
September 10, 2014
First Posted
October 16, 2014
Study Start
September 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
October 27, 2023
Record last verified: 2023-10