Clinical trial NCT00493909: 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: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: thoracotomy
pain therapy
thoracic paravertebral blockade
intrathecal opioids
thoracic epidural analgesia
Analgesia after thoracotomy
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2007-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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).
timeFrame: within the first three days
Secondary outcomes:
measure: 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.
timeFrame: within one year
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Department of Thoracic Surgery, University Medical Center
Study officials:
affiliation: Department of Anesthesiology and Critical Care Medicine, University Medical Center, Hugstetterstrasse 55, D-79106 Freiburg, Germany,
name: Torsten Loop, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Thoracic Surgery, University Medical Center, Hugstetterstrasse 55, D-79106 Freiburg, Germany,
name: Sebastian Dango, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dango S, Harris S, Offner K, Hennings E, Priebe HJ, Buerkle H, Passlick B, Loop T. Combined paravertebral and intrathecal vs thoracic epidural analgesia for post-thoracotomy pain relief. Br J Anaesth. 2013 Mar;110(3):443-9. doi: 10.1093/bja/aes394. Epub 2012 Nov 14.