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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
Sponsor:
Information provided by:
University Hospital Freiburg

Brief Summary:
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 or disease Intervention/treatment Phase
Pain, Postoperative Procedure: intrathecal opioids and thoracic paravertebral analgesia Procedure: thoracic epidural analgesia Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
Germany
Department of Thoracic Surgery, University Medical Center
Freiburg, Germany, D-79106
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,

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00493909     History of Changes
Other Study ID Numbers: TL-2007-06
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents