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Completed

NCT Number: NCT06235944

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

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.

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Key information

Age range

3 year–6 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caudal block

Procedure

Patients 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.

Sacral Erector Spinae Block

Procedure

Patients 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).

Primary outcomes

  1. Time to first rescue analgesic.

    Time frame: 24 hours postoperatively

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

Secondary outcomes

  1. Total rescue analgesia consumption

    Time frame: 24 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

  2. The degree of pain

    Time frame: 24 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Efficacy of Post-operative Analgesia of Sacral Erector Spinae Plane Block Versus Caudal Block in Penile Surgeries in Pediatrics

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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