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

NCT ID: NCT06235944

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-04-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Caudal block

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.

Group Type: EXPERIMENTAL

Caudal block

Intervention Type: 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

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).

Group Type: EXPERIMENTAL

Sacral erector spinae block

Intervention Type: 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).

Interventions

Caudal block

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.

Intervention Type: PROCEDURE

Sacral erector spinae block

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Aya Allah Hamdy Elbahy

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

34989/10/21

Identifier Type: -

Identifier Source: org_study_id