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

NCT06235944 | Completed

• 1 other identifier: 34989/10/21
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacral Erector Spinae Plane Block; Caudal Block; Penile Surgeries; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesic.

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

  24 hours postoperatively

Secondary Outcomes (2)

• Total rescue analgesia consumption

  24 hours postoperatively

• The degree of pain

  24 hours postoperatively

Study Arms (2)

Caudal block

EXPERIMENTAL

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.

Procedure: Caudal block

Sacral erector spinae

EXPERIMENTAL

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).

Procedure: Sacral erector spinae block

Interventions

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.

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).

Sacral erector spinae

Eligibility Criteria

• Age: 3 Years - 6 Years
• Gender Eligibility Details: Male children who undergoing penile surgery.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 3 to 6 years.
• Male children.
• American Society of Anesthesiologists (ASA) I - II.
• Male who admitted for penile surgeries.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 1, 2024
• Study Start: February 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)