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

Pediatrics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06235944
• Other study ID #: 34989/10/21
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caudal Block
• Pediatrics

Intervention

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.
• 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).

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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