Trial document





This trial has been registered retrospectively.
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  DRKS00007529

Trial Description

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Title

Paravertebral versus systemic Analgesia for video-assisted Lobectomy

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Trial Acronym

VATSLOPAIN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

An effective pain management is essential for patients undergoing thoracic Surgery. For minimal-invasive procedures the optimal pain management is unclear. Therefore we looked for the differences in two pain management regimens established at our clinic.

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Brief Summary in Scientific Language

Video-assisted thoracic surgery (VATS) is a less invasive surgical procedure than open thoracotomy and may implicate a lower acute postoperative pain level. Nevertheless, postoperative pain after VATS will adversely affect the ability to cough, deep breathing, and lung function, resulting in respiratory complications and delayed recovery. The optimal postoperative analgesic strategy after video-assisted thoracic surgery (VATS) lobectomy remains an open issue. Thoracic epidural analgesia (TEA) is commonly considered the gold standard for the relief of acute post-thoracotomy pain. Thoracic paravertebral blockade has also been shown to be efficacious for pain relief. Since there is no ideal regional technique for pain relief after VATS, continuous thoracic paravertebral analgesia with local anaesthetic may be a suitable alternative. Accordingly, we hypothesized that thoracic paravertebral blockade with ropivacaine would provide better analgesia comparable to that during systemic analgesia with parenteral opioids and non-steroidal analgesics. We further hypothesized that this regimen would have a lower incidence of respiratory complications than that of systemic analgesia, such as atelectasis, pneumonia, hypoxia or pulmonary dysfunctions.

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Organizational Data

  •   DRKS00007529
  •   2015/06/10
  •   [---]*
  •   yes
  •   Approved
  •   99/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   regional Anethesia using thoracic paravertebral analgesia, Ropivacain 0,2% with flow rate 8 ml/h, retrospective data collection
  •   iv Opioid, PCA with application of Piritramide, bolus each with 3 mg, retrospective data collection
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

postoperative pain using visual analog scale 4h, 8h, 16h, 24h, 48h and 72h postoperative

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Secondary Outcome

Respiratory adverse events
Spirometry at discharge
Duration of hospital stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/04/07
  •   160
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

• Inclusion criteria: Sex: male/female; Age: 18 – 75 years; informed consent of the patient; elective VATS lobectomy;
Lobectomy between 01.01.2014 and 01.01.2015

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Exclusion Criteria

• Exclusion criteria: switch to open thoracotomy resection; contraindications against the use of regional techniques: known allergy to local anaesthetics; infection around the puncture site; coagulation disorders; Scoliosis; drug abuse; emergency surgery; pregnancy. Language barrier; death

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Dr.  Benedikt  Haager 
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Dr.  Benedikt  Haager 
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.