Clinical trial NCT05600296: Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hernia, Inguinal
Keywords: inguinal herniotomy
ilioinguinal nerve block
iliohypogastric nerve block
spermatic cord block
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 46
Sex: MALE
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor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

Eligibility criteria: 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

Primary outcomes:
measure: Rescue Analgesia
timeFrame: From base line to 6 hours postoperatively
measure: Post Operative Pain
timeFrame: From base line to 6 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university Hospital
Study officials:
affiliation: Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.
name: Mona Gad, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References: