Trial document





This trial has been registered retrospectively.
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  DRKS00019220

Trial Description

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Title

Sufficient analgesia with patient-controlled analgesia compared to epidural anaesthesia in patients after robotic assisted minimal invasive esophagectomy (RAMIE)

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Comparison between patient-controlled analgesia (PCA) and epidural anaesthesia (EDA) regarding the quality of postoperative analgesia in patients after robotic assisted minimally invasive esophagectomy

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Brief Summary in Scientific Language

Comparison between patient-controlled analgesia (PCA) and epidural anaesthesia (EDA) regarding the quality of postoperative analgesia in patients after robotic assisted minimally invasive esophagectomy measured with the numeric-rating-scale, cumulative dosage of analgesics and use of co-anagesics

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Organizational Data

  •   DRKS00019220
  •   2019/11/13
  •   [---]*
  •   yes
  •   Approved
  •   837.512.17 (11346), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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

  •   C15 -  Malignant neoplasm of oesophagus
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Interventions/Observational Groups

  •   Patients who didn't receive an epidural analgesia preoperatively:
    Patient-controlled analgesia
    Intravenous piritramid-PCA, Bolus 1,5mg, blocking time 10min, 4h-maximum: 30mg, study visits on the first, third and seventh postoperative day
  •   Patients who received a thoracic epidural catheter:
    Carbostesine 0,125%, rates from 5 to 15 ml/h, Bolus 3ml, blocking time 20min
    study visits on the first, third and seventh postoperative day
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Characteristics

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

Postoperative quality of analgesia regarding NRS/VAS at rest and while moving

Postoperative amount of analgesics

Use of co-analgesics

Duration of postoperative analgesia

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Secondary Outcome

Intraoperative use of analgesia

Ventilation parameters (peak pressure, compliance)

Single-lung ventilation (SLV) (duration, need of additional cpap)

duration of surgery and ventilation

blood gas tests (awake, start of surgery, before single-lung-ventilation, after 10min of SLV, before end of surgery)

duration of hospital stay

first physiotherapeutic treatment possible

RASS and NRS for nausea and vomiting

FEV1 before and after surgery

postoperative complications (re-admission icu, pneumonia, sepsis, anastomotic insufficiency)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/03/18
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

age ≥ 18 years
no enrollment in other clinical study
person capable of giving consent
elective RAMIE surgery

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Exclusion Criteria

age < 18 years
missing consent
inability of giving consent
ASA ≥ 4
Premedication with opioids
Patients with a chronic pain syndrome
Patients with a diagnosed polyneuropathy
Patients with a diagnosed psychic disorder
Simultaneous enrollment in another clinical study

Patients with contraindications for EDA will receive no EDA

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesiologie Universitätsmedizin Mainz
    • Ms.  Dr. med.  Eva-Verena  Griemert 
    • Langenbeckstr.1
    • 55131  Mainz
    • Germany
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    • Klinik für Anästhesiologie Universitätsmedizin Mainz
    • Ms.  Ann Kristin  Rosner 
    • Langenbeckstr.1
    • 55131  Mainz
    • Germany
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    • Klinik für Anästhesiologie Universitätsmedizin Mainz
    • Ms.  Ann Kristin  Rosner 
    • Langenbeckstr.1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie Universitätsmedizin Mainz
    • Ms.  Ann Kristin  Rosner 
    • Langenbeckstr.1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/10/17
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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.