Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia

February 25, 2010 updated by: University of Ulm

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89075
        • Universtity Clinic Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain at rest and on coughing after thoracic surgery
Time Frame: Pain during the first four postoperative days
Pain during the first four postoperative days

Secondary Outcome Measures

Outcome Measure
Time Frame
pulmonary function (peak expiratory flow rate) after thoracic surgery
Time Frame: first four postoperative days
first four postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Study Chair: Michael Georgieff, Prof., Department for Anesthesiology University Clinic Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 26, 2010

Last Update Submitted That Met QC Criteria

February 25, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDA-ICB 198/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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