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

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Current Smokers; Never Smokers; Past Smokers

Treatments: Procedure: 5 ml arterial blood

Study type: Interventional

Funder types: Other

Identifiers

NCT02266212

VGHKS101-016

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Smoke

Active Comparator group

Description:

Fagerstrom test for nicotine dependence

Treatment:

Procedure: 5 ml arterial blood

Pain

Active Comparator group

Description:

pain during post-operation Day1 to Day4

Treatment:

Procedure: 5 ml arterial blood

Morphine

Active Comparator group

Description:

Morphine consumption during post-operation Day1 to Day4

Treatment:

Procedure: 5 ml arterial blood