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
  Purpose

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


Condition Intervention
Thoracotomy
Procedure: epidural anesthesia
Procedure: intercostal anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Pain at rest and on coughing after thoracic surgery [ Time Frame: Pain during the first four postoperative days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pulmonary function (peak expiratory flow rate) after thoracic surgery [ Time Frame: first four postoperative days ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: February 2007
Study Completion Date: October 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: epidural anesthesia 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.
Active Comparator: intercostal anesthesia 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01076894

Locations
Germany
Universtity Clinic Ulm
Ulm, Germany, 89075
Sponsors and Collaborators
University of Ulm
Investigators
Study Chair: Michael Georgieff, Prof. Department for Anesthesiology University Clinic Ulm
  More Information

No publications provided

Responsible Party: Department of Anesthesiology, University Clinic Ulm
ClinicalTrials.gov Identifier: NCT01076894     History of Changes
Other Study ID Numbers: EDA-ICB 198/06
Study First Received: February 25, 2010
Last Updated: February 25, 2010
Health Authority: Ethics Commission: Germany

Keywords provided by University of Ulm:
pain
thoracotomy
pulmonary function
epidural anesthesia
intercostal nerve block

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014