NCT05600296

Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block

Completed Phase 1 Last updated 19 October 2023

What this trial tests

Phase 1 trial testing Levobupivacaine in Hernia, Inguinal in 46 participants. Completed in 15 May 2023.

Timeline

1 November 2022

Primary endpoint
1 May 2023

15 May 2023

Quick facts

Lead sponsor	Egymedicalpedia
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	46
Start date	1 November 2022
Primary completion	1 May 2023
Estimated completion	15 May 2023
Sites	1 location across Egypt

Drugs / interventions tested

• Levobupivacaine (LEVOBUPIVACAINE) — full drug profile →
• Ilioinguinal/iliohypogastric nerve block (IINB)
• IINB+ Spermatic cord block

Conditions studied

• Hernia, Inguinal — all drugs for Hernia, Inguinal →

Sponsor

Egymedicalpedia — full company profile →

Who can join

Adults 12 Months to 60 Months, male only, with Hernia, Inguinal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single center randomized, controlled, double-blinded, noninferiority study. Male pediatric patients who underwent inguinal herniotomy will be screened for eligibility. Patients will be randomly allocated to IINB and IINB/SCB groups with allocation ratio 1:1. The primary outcome measure will be the proportion of patients who needed rescue analgesia during the first postoperative 6 h. The secondary outcome measures will be intraoperative heart rate and mean arterial blood pressure (MAP), the postoperative pain FLACC pain scale, and intravenous paracetamol consumption, the incidence of adverse effects including hematoma, postoperative vomiting and fever.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.