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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00493909
Enrollment
200
Registered
2007-06-29
Start date
2007-06-30
Completion date
2008-12-31
Last updated
2009-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

thoracotomy, pain therapy, thoracic paravertebral blockade, intrathecal opioids, thoracic epidural analgesia, Analgesia after thoracotomy

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.

Interventions

PROCEDUREintrathecal opioids and thoracic paravertebral analgesia
PROCEDUREthoracic epidural analgesia

Sponsors

University Hospital Freiburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026