Clinical trial NCT05832671: Ultrasound Guided Erector Spinae Muscle Block in Pediatric Surgeries
Official title: Ultrasound Guided Erector Spinae Muscle Block on Postoperative Pain in Pediatric Patient Undergoing Hip Reconstruction Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Hip Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* • ASA I and II,

  * aged 2-6 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

Primary outcomes:
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale 2 hours postoperative
timeFrame: first postoperative 24 hours
Secondary outcomes:
measure: time to the first analgesic request
timeFrame: recorded in hours for the first 24 hour
measure: total analgesic requests
timeFrame: 24 hours
measure: Emergence agitation using Paediatric Anaesthesia Emergence Delirium (PAED) scale.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Shimaa A Hassan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: