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

October 25, 2023 updated by: Yuan-Yi Chia, Kaohsiung Veterans General Hospital.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Smoke
Fagerstrom test for nicotine dependence
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).
Active Comparator: Pain
pain during post-operation Day1 to Day4
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).
Active Comparator: Morphine
Morphine consumption during post-operation Day1 to Day4
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fagerstrom test for nicotine dependence
Time Frame: Post-operation Day1 to Day4
Post-operation Day1 to Day4

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects
Time Frame: Post-operation Day1 to Day4
site effects include dizzy, vomit, lethargic sleep and pruritus
Post-operation Day1 to Day4
Morphine consumption
Time Frame: Post-operation Day1 to Day4
Differences in postoperative morphine consumption between the 3 groups
Post-operation Day1 to Day4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

October 12, 2014

First Posted (Estimated)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • VGHKS101-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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