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Clinical Trials/NCT00493909
NCT00493909
Completed
Phase 4

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

University Hospital Freiburg1 site in 1 country200 target enrollmentJune 2007

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
University Hospital Freiburg
Enrollment
200
Locations
1
Primary Endpoint
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).
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
December 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Freiburg

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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.(within one year)

Study Sites (1)

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