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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to compare whether epidural analgesia would provide equal analgesia than combining intrathecal opioids with thoracic paravertebral local anesthetics.

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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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1

thoracic epidural analgesia

Group Type ACTIVE_COMPARATOR

intrathecal opioids and thoracic paravertebral analgesia

Intervention Type PROCEDURE

thoracic epidural analgesia

Intervention Type PROCEDURE

2

intrathecal opioids and thoracic paravertebral analgesia

Group Type ACTIVE_COMPARATOR

intrathecal opioids and thoracic paravertebral analgesia

Intervention Type PROCEDURE

Interventions

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intrathecal opioids and thoracic paravertebral analgesia

Intervention Type PROCEDURE

thoracic epidural analgesia

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No