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Sacral Erector Spinae Plane Block Versus Caudal Block in Penile Surgeries in Pediatrics

Not Applicable
Completed
Conditions
Sacral Erector Spinae Plane Block
Caudal Block
Pediatrics
Penile Surgeries
Interventions
Procedure: Sacral erector spinae block
Procedure: Caudal block
Registration Number
NCT06235944
Lead Sponsor
Tanta University
Brief Summary

The study will be conducted to compare the efficacy of ultrasound guided Sacral Erector Spinae Plane Block to caudal block on pain management in penile surgeries in pediatrics.

Detailed Description

The erector spinae plane block (ESPB) is a relatively new interfacial plane block that is used for postoperative analgesia in penile surgeries in pediatrics.

The sacral ESPB is a technique known to block the posterior branches of the sacral nerves. Also it blocks the lumbosacral plexus especially the sacral spinal nerves (S2_S4) when applied to high levels.

Caudal epidural block in children is one of the most widely administrated technique of regional anesthesia; it is an efficient way to offer perioperative analgesia for painful sub umbilical interventions. It enables early ambulation, hemodynamic stability and spontaneous breathing in patient groups at maximum risk of difficult airway.

Caudal block is a known worldwide technique but with some risks such as subdural, intra vascular injection, infection, injury to the nerve root or local anesthesia. Therefore, we try a new technique as sacral ESPB.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
70
Inclusion Criteria
  • Children aged between 3 to 6 years.
  • Male children.
  • American Society of Anesthesiologists (ASA) I - II.
  • Male who admitted for penile surgeries.
Exclusion Criteria
  • Parents who refused regional anesthesia.
  • Patients presented with symptoms or signs of increased intracranial tension.
  • Patients presented with advanced kidney, cardiac or liver diseases.
  • Coagulation and bleeding disorders.
  • Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
  • Pre-existing neurologic disease (e.g. lower extremity peripheral neuropathy).
  • Patients with known allergy to study drugs.
  • Patints with developmental or mental delay.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sacral erector spinaeSacral erector spinae blockPatients were received (plain bupivacaine 0.25% 1 mg/kg + 2 % lidocaine 3 mg /kg) in total volume of 1 ml/ kg maximum 20ml divided in both sides via ultrasound guided sacral erector spinae plain block (ESPB).
Caudal blockCaudal blockPatients were received (plain bupivacaine 0.25% 1 mg/kg + 2 % lidocaine 3 mg /kg) in total volume 1ml/ kg max 20 ml via Ultrasound Guided caudal Block.
Primary Outcome Measures
NameTimeMethod
Time to first rescue analgesic.24 hours postoperatively

The time to first rescue analgesia was measured from the end to surgery till first dose of paracetamol administrated.

Secondary Outcome Measures
NameTimeMethod
Total rescue analgesia consumption24 hours postoperatively

Total analgesic consumption (postoperative paracetamol IV 15 mg/kg) used if FLACC was 4 or more.

The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale The range from 0 to 10 with 0 representing no pain, 10 representing the worst pain

The degree of pain24 hours postoperatively

The degree of pain was assessed after surgery over 24 hours using Face, Legs, Activity, Cry and Consolability (FLACC) score at time (30 minutes postoperative, 2, 4, 6, 12, 18, 24 hours).

FLACC score is used for pain assessment in children between age of 3 to 6 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0 to 10 with 0 representing no pain, 10 representing the worst pain and we start to give rescue analgesia at score 4.

Trial Locations

Locations (1)

Tanta University

🇪🇬

Tanta, El-Gharbia, Egypt

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