|- candidate number||24440|
|- NTR Number||NTR5940|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jun-2016|
|- Secondary IDs||15.122 // NL 54946.015.15 METC // CCMO|
|- Public Title||Postoperative pain reduction following umbilical hernia repair|
|- Scientific Title||Elective Umbilical Hernia Repair: Outcomes of postoperative Pain in Adults after local Wound Infiltration or ultrasound-guided bilateral REctus Sheath block. (EUHROPA WIRES trial)|
|- Healt Condition(s) or Problem(s) studied||Umbilical hernia, Post-operative pain|
|- Inclusion criteria||Adult (>18 years old) |
ASA-classification between I-III,
elective open primary umbilical hernia repair.
|- Exclusion criteria||- primary umbilical hernia repair via scopic |
- 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
- 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-
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-mei-2016|
|- planned closingdate|
|- Target number of participants||66|
|- Interventions||ultrasound guided bilateral rectus sheath block
local wound infiltration.
|- Primary outcome||proportion of patients with a pain intensity of 3 or less, as assessed by the NRS|
|- Secondary outcome||postoperative 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
|- Timepoints||10 minutes after arrival at the PACU|
30 minutes postoperatively
3, 6, 12 and 24 hours postoperatively.
|- Trial web site|
|- status||open: 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|
(Source(s) of Monetary or Material Support)
|Máxima Medical Center|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||3-jun-2016 - 23-aug-2016|