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Ultrasound Guided Erector Spinae Muscle Block in Pediatric Surgeries

Not Applicable
Recruiting
Conditions
Pediatric Hip Surgery
Interventions
Procedure: caudal block
Procedure: Erector Spinae muscle block
Registration Number
NCT05832671
Lead Sponsor
Assiut University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
70
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ultrasound-guided caudal blockcaudal blockpatients 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.
US guided erector spinae muscle blockErector Spinae muscle blockpatients will receive US-guided erector spinae muscle block with a total volume of 0.4 mg/kg of 0.25% bupivacaine.
Primary Outcome Measures
NameTimeMethod
Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale 2 hours postoperativefirst postoperative 24 hours

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

Secondary Outcome Measures
NameTimeMethod
Emergence agitation using Paediatric Anaesthesia Emergence Delirium (PAED) scale.24 hours

PAED score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation. Emergence agitation and postoperative pain (scores of ≥ 10) will be managed by intravenous doses of fentanyl 0.5 mic/kg, repeated after 10 min if the child still agitated or in pain, with a maximum total dose of 2 mic/kg.

total analgesic requests24 hours

total consumption of postoperative analgesics

time to the first analgesic requestrecorded in hours for the first 24 hour

the first time to pain scores are high and rescue analgesic is given

Trial Locations

Locations (1)

Assiut University

🇪🇬

Assiut, Egypt

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