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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: intrathecal opioids and thoracic paravertebral analgesia; Procedure: thoracic epidural analgesia

• Registration Number: NCT00493909
• Lead Sponsor: University Hospital Freiburg

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-28
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-06-29
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	intrathecal opioids and thoracic paravertebral analgesia	thoracic epidural analgesia
1	thoracic epidural analgesia	thoracic epidural analgesia
2	intrathecal opioids and thoracic paravertebral analgesia	intrathecal opioids and thoracic paravertebral analgesia

Primary Outcome Measures

Name	Time	Method
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).	within the first three days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Thoracic Surgery, University Medical Center; 🇩🇪 Freiburg, Germany