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

Hernia, Inguinal Clinical Trial

Official title:

Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block in Inguinal Herniotomy Operation in Children: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600296
• Other study ID #: Mona Gad 2
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: October 2023
• Source: Egymedicalpedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Inguinal herniotomy in children is a frequent surgical procedure that require good postoperative analgesia. Ultrasound-guided ilioinguinal/iliohypogastric nerve block is a widely validated anesthetic technique for this procedureز Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor hemodynamic changes and can be done in the presence of contraindications of the neuraxial block . Ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) is commonly done in pediatric patients to control pain after lower abdominal surgeries and has been shown to be effective in controlling pain after inguinal hernia repair . However IINB don't affect the genitofemoral neve that contributes the sensory innervation of the inguinal region. The spermatic cord (SC) is a unique male structure that contains the vas deferens, testicular arteries, the pampiniform plexus of veins, and the ilioinguinal nerve and genital branch of the genitofemoral nerve (GFN). To provide complete analgesia for inguinal hernia surgery, GFN should be blocked in addition to IINB .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 15, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Months to 60 Months

Eligibility

Inclusion Criteria:

• Male pediatric patients
• underwent elective open unilateral inguinal herniotomy
• Informed written consent will be obtained from the parents or the legal guardian.

Exclusion Criteria:

• local infection at the puncture site,
• bleeding disorder,
• allergy to amide local anesthetics,
• history of clinically significant cardiac, hepatic, or renal disorders.
• neurological dysfunction

Related Conditions & MeSH terms

• Hernia, Inguinal

Intervention

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)
• IINB+ Spermatic cord block
IINB+ Spermatic cord block

Locations

Country	Name	City	State
Egypt	Mansoura university Hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rescue Analgesia	Assessment of the proportion of patients who needed rescue analgesia. Intravenous paracetamol 15mg/kg will be given as a rescue analgesic if FLACC pain scale = 4	From base line to 6 hours postoperatively
Primary	Post Operative Pain	Assessment of The pain level of the cases by (Face, Leg, Activity, Cry, Consolability) pain scale (FLACC ) means of the digital pain.	From base line to 6 hours postoperatively