Skip to main content
OpenTrials
Completed

NCT Number: NCT07127601

Comparative Study Between US Guided Erector Spinae and US Guided Cudal Epidural Block

Inguinal hernia is a common condition requiring surgical repair in the pediatric age group. The incidence of inguinal hernias is approximately 3% to 5% in term infants and 13% in infants born at less than 33 weeks of gestational age. Inguinal hernias in both term and preterm infants are commonly repaired shortly after diagnosis to avoid incarceration of the hernia. Given the lack of definitive data, optimal timing for repair of inguinal hernias in infants remains debatable[1].

: An erector spinae plane block is a relatively new regional anesthetic technique. Apart from case reports and small series, the literature regarding pediatric use is limited.

The first author to describe caudal anaesthesia as applied to children (here in connection with urologic surgical procedures) was Meredith Campbell in 1933.(2) Over time, this idea has developed into a technique of great interest, especially for use in premature infants and in newborns, considering that these paediatric subgroups are, as a result of an immature state of the CNS, at high risk of perioperative respiratory depression.

This study will be conducted to compare caudal versus ESPB as regard intraoperative and postoperative analgesia in unilateral inguinal hernia and the feasibility of ESPB in paediatric patient.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicin, Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 3 moonths 6 years old
  • American Society of Anesthesiologists physical status I, II for non complicated inguinal hernia.

Exclusion criteria

  • Patients with a sepsis
  • malignancy anywhere
  • patient with bleeding tendencies or on anticoagulation therapy,
  • allergy to study drugs
  • congenital anomalies
  • delayed motor or developmental milestones

Treatment and study plan

Ultrasound guided erector spinae plain block (ESPB).

Procedure

Depending on the size of patient, either a 27 g 3 cm hypodermic needle or a 21 g 5 or 10 cm short bevel needle was used. All blocks were performed with the ultrasound guidance in the parasagittal position and with continuous in-plane needle visualization. The local anesthetic was deposited in the fascial plane deep to the erector spinae muscle superficial to the transverse processes, after confirming the correct tissue plane by hydro-dissection. protocols for choosing 0.25% bupivacaine with a dose of 0.5ml/kg was determined by the age and weight of the patient.

Primary outcomes

  1. heart rate response to skin incision

    Time frame: basal before surgery, after 5 minutes intra-operative, 10 minutes intra-operative, 15 minutes intra-operative

    count of heart beats per minute

Secondary outcomes

  1. pain scores

    Time frame: at recovery, 30 minutes postoperative, 1 hour postoperative, 3 hours postoperative, 6 hours postoperative

    FLACC score at recovery FLACC score at recovery FLAAC score

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparative Study Between US Guided Erector Spinae and US Guided Cudal Epidural Block in Paediatric Unilateral Inguinal Hernia Repair Adjuvant to General Anaesthesia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.