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

NCT ID: NCT07127601

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-01

Brief Summary

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.

Conditions

Anesthesia; Hernia, Inguinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Ultrasound guided erector spinae plain block (ESPB).

Group Type: EXPERIMENTAL

Ultrasound guided erector spinae plain block (ESPB).

Intervention Type: 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.

caudal analgesia (anatomically)with lumber level of anagesia

Group Type: ACTIVE_COMPARATOR

Ultrasound guided erector spinae plain block (ESPB).

Intervention Type: 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.

Interventions

Ultrasound guided erector spinae plain block (ESPB).

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Noser

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicin, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

R 14 2022

Identifier Type: -

Identifier Source: org_study_id