Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy
This study is currently recruiting participants.
Verified by University Hospital Freiburg, March 2007
Sponsored by: University Hospital Freiburg
Information provided by: University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT00493909
  Purpose

The purpose of this study is to compare whether epidural analgesia would provide equal analgesia than combining intrathecal opioids with thoracic paravertebral local anesthetics.


Condition Intervention Phase
Pain, Postoperative
Procedure: intrathecal opioids and thoracic paravertebral analgesia
Procedure: thoracic epidural analgesia
Phase IV

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • The primary outcome measures used are pain at rest, at coughing, and on movement at each time point, as reported by the patient using a standard Visual Analogue Score (VAS). [ Time Frame: within the first three days ]

Secondary Outcome Measures:
  • incidence of side-effects (nausea, vomiting, sedation score, respiratory depression, hypotension, pruritus, urinary retention), total number of doses of piritramide administered, patient satisfaction, and incidence of chronic pain. [ Time Frame: within one year ]

Estimated Enrollment: 200
Study Start Date: June 2007
Estimated Study Completion Date: June 2008
Detailed Description:

Thoracotomy is an invasive surgical procedure, which is mainly performed in patients with pre-existing lung disease such as lung cancer or chronic obstructive pulmonary disease. Pain after thoracotomy is considered the most intense acute postoperative pain, adversely affecting the ability to cough, deep breathing, and lung function, resulting in respiratory complications and delayed recovery. The adverse effects can be further aggravated by occurrence of chronic post-thoracotomy pain.

Thoracic epidural analgesia is often recommended as the gold standard for the relief of acute post-thoracotomy pain. Thoracic paravertebral blockade or intrathecal opioid analgesia has also been shown to be efficacious for pain relief. Since there is no ideal single regional technique for pain relief after thoracotomy an alternative method maybe the combination of low-dose intrathecal morphine and sufentanil plus continuous thoracic paravertebral analgesia with local anesthetics.

We therefore hypothesized that combining intrathecal sufentanil and morphine with thoracic paravertebral applicated ropivacaine would provide equal analgesia compared to thoracic epidural analgesia with ropivacaine and sufentanil. We further speculate that this new regimen would have a lower incidence of typical side effects due to TEA, such as block failure, hypotension or urinary retention.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sex: male/female
  • Age: 18 – 75 years
  • Informed consent of the patient
  • Elective thoracotomy
  • Two chest drains

Exclusion Criteria:

  • Contraindications against the use of regional techniques: known allergy to local anesthetics
  • Infection around the puncture site
  • Coagulation disorders
  • Drug abuse
  • Emergency surgery
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493909

Contacts
Contact: Torsten Loop, M.D. +49761-2702306 torsten.loop@uniklinik-freiburg.de

Locations
Germany
Department of Thoracic Surgery, University Medical Center Recruiting
Freiburg, Germany, D-79106
Contact: Torsten Loop, M.D.     +49761-2702306     torsten.loop@uniklinik-freiburg.de    
Contact: Sebastian Dango, M.D.     +49761-2702455     sebastian.dango@uniklinik-freiburg.de    
Principal Investigator: Klaus Offner, M.D.            
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Torsten Loop, M.D. Department of Anesthesiology and Critical Care Medicine, University Medical Center, Hugstetterstrasse 55, D-79106 Freiburg, Germany,
Principal Investigator: Sebastian Dango, M.D. Department of Thoracic Surgery, University Medical Center, Hugstetterstrasse 55, D-79106 Freiburg, Germany,
  More Information

Study ID Numbers: TL-2007-06
Study First Received: June 28, 2007
Last Updated: June 28, 2007
ClinicalTrials.gov Identifier: NCT00493909  
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
thoracotomy
pain therapy
thoracic paravertebral blockade
intrathecal opioids
thoracic epidural analgesia
Analgesia after thoracotomy

Study placed in the following topic categories:
Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009