Ultrasound Guided Erector Spinae Muscle Block in Pediatric Surgeries

NCT ID: NCT05832671

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2025-10-14

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.

Detailed Description

Regional anesthetic techniques have been widely used for pain management in a variety of pediatric surgeries, as they increase the efficiency of postoperative pain control; minimize parenteral opioid requirements, and improve both patient and parent satisfaction as well. The erector spinae muscle plane block (ESB) is an evolving regional anesthetic technique gaining popularity in pediatric procedures. Erector spinae block is an effective regional anesthesia method as it blocks both somatic and visceral pain by injecting the local anesthetic solution into the inter-fascial space between the transverse process and the erector spinae muscle, it is performed by distributing local anesthetic into several paravertebral spaces. it was reported a successful ultrasound-guided ESP block performed at the L4 transverse process level provided postoperative analgesia in adult patients undergoing hip and proximal femur surgeries.

Caudal block (CB) is a well-established remarkable practice because of its simplicity, safety, and effectiveness. A single-shot caudal block with a local anesthetic agent, such as bupivacaine, is a standard procedure, and analgesia is provided during pediatric orthopedic surgeries in the lower limbs; unfortunately, its action stops early in the postoperative period.

Conditions

Pediatric Hip Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

US guided erector spinae muscle block

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

Group Type: ACTIVE_COMPARATOR

Erector Spinae muscle block

Intervention Type: 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

ultrasound-guided caudal block

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.

Group Type: ACTIVE_COMPARATOR

caudal block

Intervention Type: 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.

Interventions

Erector Spinae muscle block

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

Intervention Type: PROCEDURE

caudal block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • ASA I and II,

• aged 2-7 years
• scheduled for unilateral surgical hip reconstruction under general anaesthesia.

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shimaa Abbas Hassan

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shimaa A Hassan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Other Identifiers

ESP54361

Identifier Type: -

Identifier Source: org_study_id