Elective Umbilical Hernia Repair: Outcomes of postoperative Pain in Adults after local Wound Infiltration or ultrasound-guided bilateral REctus Sheath block. (EUHROPA WIRES trial)

Completed

Conditions: Postoperative acute pain
10043413

Registration Number: NL-OMON47724

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 66

Inclusion Criteria

Adult (*18 years old) patients with an ASA-classification between I-III, who are planned for primary elective umbilical hernia repair.

Exclusion Criteria

- Patients undergoing primary EUHR via scopic surgical technique.
- Patients undergoing emergency umbilical hernia repair or patients with any previous history of umbilical hernia repair.
- Patients with simultaneous repair of other hernia defects or other surgical procedures performed during the primary EUHR.
- Patients with an ASA-classification >III.
- Patients with any contraindications for an USBRSB or LWI.
- Known allergies for LA drugs, or allergies for LA drugs that become apparent during the study course.
- Patients under chronic treatment with analgesic drugs or patients with any previous history with the medical subspecialty of Pain Medicine.
- Patients with any previous history of a laparotomy or stoma.
- Patients without informed consent (IC) and patients without the mental capacity for self-determination.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the proportion of patients with a pain intensity of 3<br /><br>or less, as assessed by the Numerical Rating Scale (NRS), at 10 minutes after<br /><br>arrival at the recovery, at 30 minutes postoperatively, and at 3, 6, 12 and 24<br /><br>hours postoperatively.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes are postoperative pain intensity as assessed by the NRS,<br /><br>postoperative use of opiate analgesics expressed as morphine equivalents, time<br /><br>to first dose of opiate analgesic, the incidence of postoperative nausea and<br /><br>vomiting (PONV), the incidence of serious adverse events (SAE) related to<br /><br>USBRSB and LWI (i.e. systemic local anaesthetic toxicity, peritoneal or<br /><br>intestinal puncture).</p><br>