Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Asan Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00935571
First received: July 8, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

The purpose of this study is to evaluate the incidence of postthoracotomy pain between total intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.


Condition Intervention
Lung Cancer
Neoplasms, Lung
Drug: propofol, remifentanil, sevoflurane

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Incidence of pain [ Time Frame: 3 and 6 months later after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain characters [ Time Frame: 3 and 6 months later after operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group I, Group II

Group I: anesthetized with TIVA (Propofol + Remifentanil)

Group II: anesthetized with inhalation (sevoflurane)

Drug: propofol, remifentanil, sevoflurane
Propofol: using target controlled infusion (TCI); 1-3ug/ml remifentanil: using TCI by 5-20 ng/ml sevoflurane: 2-3volume% (1-2 MAC)
Other Names:
  • diprivan
  • ultiva

Detailed Description:

Thoracotomy is one of the most painful surgical incisions. It has been shown that 5-80% of patients still suffer from thoracic pain 2-3 months after surgery and the international association for the study of pain (IASP) defines postthoracotomy pain syndrome (PTTS)as pain that recurs or persists at least 2 months after surgical procedure. Previous reports have shown that the incidence of PTTS varies according to preoperative pain, pain intensity, sex, and types of procedure. However, little is known about the effect of the type of anesthesia to postthoracotomy pain.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients scheduled to undergo elective thoracotomy of lung surgery

Criteria

Inclusion Criteria:

  • patients undergo elective thoracotomy of lung surgery

Exclusion Criteria:

  • emergency operation age under 18 years patients with unstable hemodynamics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935571

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Chair: In Cheol Choi, MD, PhD Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

Publications:
Responsible Party: In Cheol Choi, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00935571     History of Changes
Other Study ID Numbers: 20090708
Study First Received: July 8, 2009
Last Updated: July 8, 2009
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Anesthetics
Propofol
Sevoflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013