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

NCT05600296 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-10-19

No results posted yet for this study

Summary

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.

Conditions

  • Hernia, Inguinal

Interventions

DRUG

Levobupivacaine

Evaluation the postoperative analgesic effects by using ultrasound-guided spermatic cord block (SCB) and IINB in children scheduled for elective open inguinal herniotomy. The study hypothesized that, the combined block with SCB and IINB would result in more effective postoperative analgesia than the use of IINB alone.

PROCEDURE

Ilioinguinal/iliohypogastric nerve block (IINB)

Ilioinguinal/iliohypogastric nerve block (IINB)

PROCEDURE

IINB+ Spermatic cord block

IINB+ Spermatic cord block

Sponsors & Collaborators

  • Egymedicalpedia

    lead INDUSTRY

Principal Investigators

  • Mona Gad, Assist.Prof. · Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
60 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-05-01
Completion
2023-05-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05600296 on ClinicalTrials.gov