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Postoperative pain reduction following umbilical hernia repair


- candidate number24440
- NTR NumberNTR5940
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2016
- Secondary IDs15.122 // NL 54946.015.15 METC // CCMO
- Public TitlePostoperative pain reduction following umbilical hernia repair
- Scientific TitleElective Umbilical Hernia Repair: Outcomes of postoperative Pain in Adults after local Wound Infiltration or ultrasound-guided bilateral REctus Sheath block. (EUHROPA WIRES trial)
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedUmbilical hernia, Post-operative pain
- Inclusion criteriaAdult (>18 years old)
ASA-classification between I-III,
elective open primary umbilical hernia repair.
- Exclusion criteria- primary umbilical hernia repair via scopic
surgical technique.
- emergency umbilical hernia repair
- previous history of umbilical hernia repair.
- simultaneous repair of other hernia defects
- other surgical procedures performed during
the primary umbilical hernia repair.
- Patients with an ASA-classification >III.
- Patients with any contraindications for an ultrasound guided bilateral rectus sheath block.
- allergy for LA drugs
- chronic treatment with analgesic drugs
- previous history with the medical
subspecialty of Pain Medicine.
- previous history of a laparotomy or stoma.
- no informed consent (IC)
- impaired mental capacity for self- determination.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-mei-2016
- planned closingdate
- Target number of participants66
- Interventionsultrasound guided bilateral rectus sheath block

local wound infiltration.
- Primary outcomeproportion of patients with a pain intensity of 3 or less, as assessed by the NRS
- Secondary outcomepostoperative pain intensity as assessed by the NRS

postoperative use of analgesics

time to first dose of opiate analgesic

the incidence of PONV

the incidence of SAE related to USBRSB and LWI
- Timepoints10 minutes after arrival at the PACU
30 minutes postoperatively
3, 6, 12 and 24 hours postoperatively.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES B.P.C.M. van de Ven
- CONTACT for SCIENTIFIC QUERIES B.P.C.M. van de Ven
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Máxima Medical Center
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD3-jun-2016 - 23-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl