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

NCT07127601 | Completed DMC

• 1 other identifier: R 14 2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• heart rate response to skin incision

  count of heart beats per minute

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

Secondary Outcomes (1)

• pain scores

  at recovery, 30 minutes postoperative, 1 hour postoperative, 3 hours postoperative, 6 hours postoperative

Study Arms (2)

Ultrasound guided erector spinae plain block (ESPB).

EXPERIMENTAL

Procedure: Ultrasound guided erector spinae plain block (ESPB).

caudal analgesia (anatomically)with lumber level of anagesia

ACTIVE COMPARATOR

Procedure: Ultrasound guided erector spinae plain block (ESPB).

Interventions

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.

Ultrasound guided erector spinae plain block (ESPB).; caudal analgesia (anatomically)with lumber level of anagesia

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicin, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: August 17, 2025
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 17, 2025

Record last verified: 2024-06

Locations

EG (1)