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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47724

Enrollment

Registered

2015-11-30

Start date

2016-05-23

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative acute pain

Interventions

In the intervention group, after induction of general anesthesia (GA) and before surgical incision, patients receive an ultrasound-guided bilateral rectus sheath block with 20 ml ropivacaine 0.75% b

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)