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Sponsored by: |
University Hospital Freiburg |
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Information provided by: | University Hospital Freiburg |
ClinicalTrials.gov Identifier: | NCT00493909 |
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 |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2008 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Torsten Loop, M.D. | +49761-2702306 | torsten.loop@uniklinik-freiburg.de |
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. |
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, |
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 |
thoracotomy pain therapy thoracic paravertebral blockade |
intrathecal opioids thoracic epidural analgesia Analgesia after thoracotomy |
Signs and Symptoms Postoperative Complications Pain Pain, Postoperative |
Pathologic Processes |