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Clinical Trials/NCT02266212
NCT02266212CompletedNot Applicable

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

Kaohsiung Veterans General Hospital.1 site in 1 country300 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
300
Locations
1
Primary Endpoint
Fagerstrom test for nicotine dependence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Smoke

Active Comparator

Fagerstrom test for nicotine dependence

Intervention: 5 ml arterial blood (Procedure)

Pain

Active Comparator

pain during post-operation Day1 to Day4

Intervention: 5 ml arterial blood (Procedure)

Morphine

Active Comparator

Morphine consumption during post-operation Day1 to Day4

Intervention: 5 ml arterial blood (Procedure)

Outcomes

Primary Outcomes

Fagerstrom test for nicotine dependence

Time Frame: Post-operation Day1 to Day4

Secondary Outcomes

  • Differences in pain intensity between the three groups after postoperative analgesia.(Post-operation Day1 to Day4)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yuan-Yi Chia

anesthesia doctor

Kaohsiung Veterans General Hospital.

Study Sites (1)

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