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

Phase 1

Completed

• Conditions: Hernia, Inguinal
• Interventions: Drug: Levobupivacaine; Procedure: IINB+ Spermatic cord block; Procedure: Ilioinguinal/iliohypogastric nerve block (IINB)

• Registration Number: NCT05600296
• Lead Sponsor: Egymedicalpedia

Brief 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.

Detailed 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Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor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 .

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-10-31
• Study Start: 2022-11-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IINB+ Spermatic cord block	IINB+ Spermatic cord block	evaluate the postoperative analgesic effects with using ultrasound-guided IINB + spermatic cord block (SCB) in children scheduled for elective open inguinal herniotomy.
Ilioinguinal/iliohypogastric nerve block (IINB)	Ilioinguinal/iliohypogastric nerve block (IINB)	evaluate the postoperative analgesic effects with using ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) in children scheduled for elective open inguinal herniotomy.
Ilioinguinal/iliohypogastric nerve block (IINB)	Levobupivacaine	evaluate the postoperative analgesic effects with using ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) in children scheduled for elective open inguinal herniotomy.
IINB+ Spermatic cord block	Levobupivacaine	evaluate the postoperative analgesic effects with using ultrasound-guided IINB + spermatic cord block (SCB) in children scheduled for elective open inguinal herniotomy.

Primary Outcome Measures

Name	Time	Method
Rescue Analgesia	From base line to 6 hours postoperatively	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
Post Operative Pain	From base line to 6 hours postoperatively	Assessment of The pain level of the cases by (Face, Leg, Activity, Cry, Consolability) pain scale (FLACC ) means of the digital pain.

Trial Locations

Locations (1)

Mansoura university Hospital; 🇪🇬 Mansoura, Egypt