Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 28, 2007

Last Updated Date

February 12, 2009

Start Date ^†

June 2007

Current Primary Outcome Measures ^†

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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00493909 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief 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

Official Title ^†

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.

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 Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Pain, Postoperative

Intervention ^†

Procedure: intrathecal opioids and thoracic paravertebral analgesia
Procedure: thoracic epidural analgesia

Study Arms / Comparison Groups

Active Comparator: thoracic epidural analgesia
Active Comparator: intrathecal opioids and thoracic paravertebral analgesia

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

200

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00493909

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University Hospital Freiburg

Collaborators ^††

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,

Information Provided By

University Hospital Freiburg

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.