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NCT Number: NCT05600296

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

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.

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Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

12 month–60 month

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mansoura university Hospital

Al Mansurah, Egypt

About this study

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Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine

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)

Procedure

Ilioinguinal/iliohypogastric nerve block (IINB)

IINB+ Spermatic cord block

Procedure

IINB+ Spermatic cord block

Primary outcomes

  1. Rescue Analgesia

    Time frame: 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

  2. Post Operative Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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