Trial document





This trial has been registered retrospectively.
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  DRKS00006559

Trial Description

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Title

Post-caesarean section analgesia: efficacy of in-wound infusion for levobupivacaine and ketorolac

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

-To find the most effective drug or combination of drugs to achieve less opioid requirement after caesarean section.
- Analgesia drug infusion through the in-wound catheter for 48 hours. The surgeon puts the catheter in site at the end of the C-section.
- Parturients age 18+ with no allergy to local anaesthetics or NSAID drugs, first C-section, graviditas >37 weeks, no contraindicatios for regional anaesthesia, healthy
- Outcome: opioid consumption; pain scores, chronic pain
- Tested hypothesis: Is the combination of local anaesthetic and NSAID drug, given locally, the most effetcive to reduce opioid consumption?

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Brief Summary in Scientific Language

-Is local analgesia with in-wound infusion with levobupivacaine and ketorolac for 48 hours safe and effective to reduce opioid consumption after caesarean section?
- ASA 1 and 2, parturients 18+, graviditas > 37 weeks, no previous C-section, no allergy to local anaesthetics, NSAIDs or paracetamol; no contraindications for regional anaesthesia
- At the end of the C-section subcutaneous catheter will be put in by the surgeon and connected to the elastomeric pump.
- Postoperative consumption of opioid piritramid will be checked.
- After 48 hours the catheter will be send for microbiological test.
- After 8 weeks: checking for residual pain at the operative scar.

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Organizational Data

  •   DRKS00006559
  •   2014/07/30
  •   [---]*
  •   yes
  •   Approved
  •   169/07/11, Republic Committee for Medical Ethics, Ministry for Health, Slovenia
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Secondary IDs

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Health Condition or Problem studied

  •   Analgesia after c-section
  •   O82 -  Single delivery by caesarean section
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Interventions/Observational Groups

  •   in-wound catheter with elastomeric pump ( On Q Pain Buster 270 ml) for continuous infusion 5 ml/h over the fascia, for 48 hours
    - group 1: 0,25% levobupivacaine
  •   - in-wound catheter with elastomeric pump ( On Q Pain Buster 270 ml) for continuous infusion 5 ml/h over the fascia, for 48 hours: group 2: ketorolac 240 mg in 0,9% NaCl
  •   - in-wound catheter with elastomeric pump ( On Q Pain Buster 270 ml) for continuous infusion 5 ml/h over the fascia, for 48 hours: group 3: 0,25% levobupivacaine plus ketorolac 240 mg
  •   - in-wound catheter with elastomeric pump ( On Q Pain Buster 270 ml) for continuous infusion 5 ml/h over the fascia, for 48 hours: group 4: 0,9% NaCl
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   Yes
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Primary Outcome

consumption of opioid piritramid in miligrams in 24 and 48 hours; writing on a check-list

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Secondary Outcome

Pain:VAS score at 1st, 3rd,6th, 12th, 18th, 24th, 36th, 48th hour ; microbiological test of catheters, persistent pain after 8 weeks post C-section

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Countries of Recruitment

  •   Slovenia
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/01/22
  •   88
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

first caesarean section, non-emergency; 37 or more weeks of pregnancy, ASA 1 and 2; no contraindications for regional anaesthesia; no allergy to local anaesthetics, NSAID drugs or paracetamol;

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Exclusion Criteria

- previous big abdominal operations,
- BMI 30 or more before conception;
- drug or alcochol abuse,
- ASA 3 or more;
- allergy: local anaesthetics, NSAID, paracetamol

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Addresses

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    • UKC Maribor
    • Ms.  Asist., MD  Jožica  Wagner Kovačec 
    • Ljubljanska 5
    • 2000  Maribor
    • Slovenia
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    • UKC Maribor
    • Ms.  MD  Jožica  Wagner Kovačec 
    • Zrkovska cesta 184 a
    • 2000  Maribor
    • Slovenia
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    • SZAIM Slovenia
    • Ms.  MD  Jožica  Wagner Kovačec 
    • Zrkovska cesta 184 a
    • 2000  maribor
    • Slovenia
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Sources of Monetary or Material Support

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    • University Clinical Centre Maribor, Department for anaesthesiology, intensive care and pain therapy
    • Ljubljanska ulica 5
    • 2000  Maribor
    • Slovenia
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Status

  •   Recruiting complete, follow-up complete
  •   2014/08/05
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Trial Publications, Results and other Documents

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