Ultrasound Guided Erector Spinae Muscle Block in Pediatric Surgeries

NCT05832671 | Completed

• 1 other identifier: ESP54361
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia.

Conditions

Pediatric Hip Surgery

Outcome Measures

Primary Outcomes (1)

• Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale 2 hours postoperative

  To evaluate the quality of postoperative analgesia using the FLACC. Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0=relaxed and comfortable, 1-3= mild discomfort, 4-6= moderate pain and 7-10= sever discomfort or pain or both

  first postoperative 24 hours

Secondary Outcomes (3)

• time to the first analgesic request

  recorded in hours for the first 24 hour

• total analgesic requests

  24 hours

• Emergence agitation using Paediatric Anaesthesia Emergence Delirium (PAED) scale.

  24 hours

Study Arms (2)

US guided erector spinae muscle block

ACTIVE COMPARATOR

patients will receive US-guided erector spinae muscle block with a total volume of 0.4 mg/kg of 0.25% bupivacaine.

Procedure: Erector Spinae muscle block

ultrasound-guided caudal block

ACTIVE COMPARATOR

patients will receive an ultrasound-guided caudal block with 2.5 mg/kg of 0.25% bupivacaine to be injected over one minute period while observing an ultrasound longitudinal image.

Procedure: caudal block

Interventions

Erector Spinae muscle block PROCEDURE

In the ESB group, the patient will be placed in the lateral position. The site of surgery is upward. After skin preparation using 10% povidone-iodine, a high-frequency linear ultrasound transducer will be placed over the ipsilateral site of surgery 1-2 cm lateral to the spine at the T10 level, counting upward from the sacrum. After identifying the erector spinae muscles and transverse process, a needle will be inserted with an in-plane technique in the craniocaudal direction

US guided erector spinae muscle block

caudal block PROCEDURE

In the CB group, patients will be placed in a lateral position. An ultrasound transducer is first placed transversely at the midline to obtain a transverse view of the 2 cornua, the sacrococcygeal ligament, sacral bone, and sacral hiatus. At this position, the ultrasound transducer will be twisted to 90° to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and will be subsequently placed between the 2 cornua and on visualization of the frog sign (the 2 sacral cornua identified as 2 hyperechoic reverse U-shaped structure) the needle will be inserted into the sacral canal under direct real-time longitudinal visualization. After negative aspiration for blood or cerebrospinal fluid, bupivacaine (0.25%) 2.5 mg/kg will be injected over a one minute period while observing an ultrasound longitudinal image.

ultrasound-guided caudal block

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I and II,
• aged 2-7 years
• scheduled for unilateral surgical hip reconstruction under general anaesthesia.

You may not qualify if:

• Children with spinal anomalies,
• altered mental status or a history of developmental delay,
• infection at the site of injection,
• history of allergy to local anaesthetics
• history of blood disease or coagulopathy,
• Patient's guardian refusal to participate in the study

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Study Officials

• Shimaa A Hassan, M.D.

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 27, 2023
• Study Start: April 3, 2025
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

EG (1)