Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy
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|ClinicalTrials.gov Identifier: NCT00493909|
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : February 16, 2009
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Procedure: intrathecal opioids and thoracic paravertebral analgesia Procedure: thoracic epidural analgesia||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: 1
thoracic epidural analgesia
|Procedure: intrathecal opioids and thoracic paravertebral analgesia Procedure: thoracic epidural analgesia|
Active Comparator: 2
intrathecal opioids and thoracic paravertebral analgesia
|Procedure: intrathecal opioids and thoracic paravertebral analgesia|
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493909
|Department of Thoracic Surgery, University Medical Center|
|Freiburg, Germany, D-79106|
|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,|