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

The Efficacy of Post-operative Analgesia of 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.

Study Overview

• Status: Completed
• Conditions: Caudal Block; Pediatrics; Sacral Erector Spinae Plane Block; Penile Surgeries
• Intervention / Treatment: Procedure: Caudal block; Procedure: Sacral erector spinae block

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total rescue analgesia consumption	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	24 hours postoperatively
The degree of pain	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.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 34989/10/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No