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

NCT ID: NCT05600296

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-05-15

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Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor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

Conditions

Hernia, Inguinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

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.

Ilioinguinal/iliohypogastric nerve block (IINB)

Intervention Type: PROCEDURE

Ilioinguinal/iliohypogastric nerve block (IINB)

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.

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

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.

IINB+ Spermatic cord block

Intervention Type: PROCEDURE

IINB+ Spermatic cord block

Interventions

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.

Intervention Type: DRUG

Ilioinguinal/iliohypogastric nerve block (IINB)

Ilioinguinal/iliohypogastric nerve block (IINB)

Intervention Type: PROCEDURE

IINB+ Spermatic cord block

IINB+ Spermatic cord block

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona Gad, Assist.Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.

Locations

Mansoura university Hospital

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

Mona Gad 2

Identifier Type: -

Identifier Source: org_study_id