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Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia

This study has been completed.
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT01076894
First received: February 25, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 25, 2010
February 25, 2010
February 2007
October 2008   (final data collection date for primary outcome measure)
Pain at rest and on coughing after thoracic surgery [ Time Frame: Pain during the first four postoperative days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
pulmonary function (peak expiratory flow rate) after thoracic surgery [ Time Frame: first four postoperative days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia
Analgesia and Pulmonary Function After Thoracic Surgery: is an Intercostal Nerve Block Plus Intravenous Morphine as Effective as Epidural Anesthesia? A Prospective Randomized Clinical Study.

Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia is commonly considered to be the "gold standard" for postoperative pain control and restoration of pulmonary function after thoracic surgery.

Thus, the aim of the present study is to investigate whether an intercostal nerve block with ropivacaine plus intravenous PCA with morphine is as effective as thoracic epidural anesthesia with respect to postoperative pain control and pulmonary
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Thoracotomy
  • Procedure: epidural anesthesia
    In the epidural group prior to the induction of general anesthesia, a thoracic epidural catheter will be was placed at the level of the TH6-TH8. 8 ml ropivacaine 1% were administered through the epidural catheter. EDA is aimed at a sensory block level from TH2 to TH10.
  • Procedure: intercostal anesthesia
    In the intercostal group, before chest closure, each 4 ml ropivacaine 0.75 % will be injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and two spaces above and below as well as 5 ml ropivacaine 0,75 % at the thoracic drainage tube exits
  • Active Comparator: epidural anesthesia
    Intervention: Procedure: epidural anesthesia
  • Active Comparator: intercostal anesthesia
    Intervention: Procedure: intercostal anesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
October 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients undergoing elective pulmonary surgery, including pneumonectomy, bilobectomy, lobectomy, typical and atypical segmentectomy, via a lateral or posterolateral thoracotomy without chest-wall resection

Exclusion Criteria:

  • age<18 yr
  • any contraindication to epidural anaesthesia, intercostal nerve block or the use of ropivacaine, morphine, metamizol or diclofenac
  • lack of patient's cooperation
  • any type of chronic painful condition or current opioid use
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01076894
EDA-ICB 198/06
No
Department of Anesthesiology, University Clinic Ulm
University of Ulm
Not Provided
Study Chair: Michael Georgieff, Prof. Department for Anesthesiology University Clinic Ulm
University of Ulm
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP