Trial document





This trial has been registered retrospectively.
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  DRKS00004648

Trial Description

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Title

Postoperative analgesia and postoperative influences on intestinal motility of peridural anaesthesia versus continous preperitonal wound infusion of ropivacaine 0.2% following elective laparotomy - a prospective, randomized, controlled, non-blinded study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Successful postoperative pain therapy leads to a significantly increased wellbeing, faster mobilisation with minimized risks of thrombosis, a shorter hospital stay and a better patient satisfaction. In the context of larger operations and following the fast track principle, peridural catheter (PDA ) have been used for years to reduce postoperative pain, to improve intestinal motility, to enhance circulation and therefore to accelerate recovery. However, placing a PDA is not always possible for every patient (neurological conditions, backbone malformations, prescribed use of anticoagulants and severe cardio-vascular conditions). Therefore other pain therapies with possibly increased side effects and reduces efficacy must be used. An alternative to PDA can be founding in abdominal wall catheters/wound infusion catheter, which have shown good efficacy in numerous studies; they are a low risk method to achieve excellent postoperative pain relieve, good healing and recovery.

In the study we measure the post-operative pain day 1-3 by the numeric scale in the morning, at noon and in the evening and the auscultation of the peristalsis postoperative day 1-3 in the morning, at noon and in the evening. Patients with elective operations concerning resections of the gastrointestinal tract of benign and malignant character with median and transverse laparotomies are included. The aime of the study is to shown that abdominal wall catheter offer an equally appropriate, safe, probably better and effective post-operative pain relieve as can be achieved with PDA.

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Brief Summary in Scientific Language

This study is to show a direct comparison between two established postoperative analgetic procedures in order to illustrate an improvement of the postoperative pain management, a reduction of opioid analgesics, a higher satisfaction of patients, an earlier mobilisation, a reduction of complications and a positive influence on intestinal motility.
Subject of the comparison are the peridural catheter (PDA), effected according to the standard of fast track procedures in two different hospitals and the wound infusion catheter (PAINfusor). The wound infusion catheter as well as the peridural catheter are part of a multimodal postopeative pain management. Defined quantities of a local anaesthetic may be applied in a specific rate for three days by a CE-certified elastomer-modified disposable pump, connected to a multi-perforated catheter, being inserted preperitoneally in the wound at the abdominal wall closure at the end of the operation

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Organizational Data

  •   DRKS00004648
  •   2013/02/25
  •   [---]*
  •   yes
  •   Approved
  •   12-5196-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   U1111-1139-0694 
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Health Condition or Problem studied

  •   postoperative analgesia
    postoperative intestinal motility
  •   R52.9 -  Pain, unspecified
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Interventions/Observational Groups

  •   Procedure 1: Peridural catheter (PDA)
    - preoperative placement of the PDA by the anaesthetists
    - postoperative continous application of ropivacaine 0.2% 6-8ml/h via perfusor
    - dolorimetry in the evening of the operation by a numeric scale
    - dolorimetry postoperative day 1-3 in the morning, at noon and in the evening by the numeric scale
    - auscultation of the intestinal motility postoperative day 1-3 in the morning, at noon and in the evening
    - additional analgesia with piritramid as a short time infusion
    - documentation of the time of the first defecation
    - removal of the PDA catheter in the evening of the third postoperative day or in the morning of the fourth postoperative day by the anaesthetist
  •   Procedure 2: wound infusion catheter:
    - utilization of industrially produced multi-perforated catheters and elastomer-modified pumps
    - preperitoneal insertion of the perforated, deaerated catheter via transcutaneous puncture for the abdominal wall closure, according to the instructions
    - filling of the elastomer-modified pump with ropivacaine 0.2%
    - connection of the catheter to the pump and adjusting quantity at rate 8ml/h
    - dolorimetry postopeative day in the evening by the numeric scale
    - dolorimetry postoperative day 1-3 in the morning, at noon and in the evening by the numeric scale
    - auscultation of the intestinal motility postoperative day 1-3 in the morning, at noon and in the evening
    - additional analgesia with piritramid as a short time infusion
    - documetation of the time of the first defecation
    - removal of the wound infusion catheter in the evening of the third postoperative day or in the morning of the fourth postoperative day by the surgeons
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome: dolorimetry pain postoperative and peristalsis postoperative. Dolorimetry postoperative pain and postoerative peristalsis in the evening of the operation day and postoperative day 1-3 in the morning, at noon and in the evening by the numeric scale and by auscultation.

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Secondary Outcome

Secondary outcome: period of hospitalisation, cost efficiency, rang of risks.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/01/02
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria:
- all elective operations concerning resections of the gastrointestinal tract of benign and malignant character (oesophagus, stomach, panreas, liver, small intestine, colon)
- median laparotomies, transverse epigastric laparotomies
- clean and clean-contaminated operations
- minimum 18 years old patients
- capability to understand and sign the objectives of the study, patient information and informed consent

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Exclusion Criteria

exlusion criteria:
- emergeny operations
- chronic pain-disorder patients with a continuous analgesic medication
- allergic disposition for amide anaesthetics
- patient with chronic defecation diseases (ODS, long bowel syndrome)
- pregnant and breast-feading women
- underage patients
- refusal by patient
- disability to understand the patient information and sign the informed consent
- infections in the puncture area respectively systemic infections

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Addresses

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    • Chirurgische Klinik I Klinik für Allgemein-, Viszeral- und Gefäßchirurgie und Koloproktologie Johanniter Krankenhaus Rheinhausen
    • Mr. 
    • Kreuzacker 1-7
    • 47228  Duisburg
    • Germany
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    •   02065-97-1201
    •   02065-97-1280
    •   [---]*
    •   [---]*
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    • Chirurgische Klinik I Klinik für Allgemein-, Viszeral- und Gefäßchirurgie und Koloproktologie Johanniter Krankenhaus Rheinhausen
    • Ms.  Anne Sabine  Vetter 
    • Kreuzacker 1-7
    • 47228  Duisburg
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Chirurgische Klinik I Klinik für Allgemein-, Viszeral- und Gefäßchirurgie und Koloproktologie Johanniter Krankenhaus Rheinhausen
    • Ms.  Anne Sabine  Vetter 
    • Kreuzacker 1-7
    • 47228  Duisburg
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgische Klinik I Klinik für Allgemein-, Viszeral- und Gefäßchirurgie und Koloproktologie Johanniter Krankenhaus Rheinhausen
    • Ms.  Anne Sabine  Vetter 
    • Kreuzacker 1-7
    • 47228  Duisburg
    • 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.