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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06235944
Enrollment
70
Registered
2024-02-01
Start date
2022-02-01
Completion date
2023-04-01
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDURECaudal 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.

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).

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
3 Years to 6 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to first rescue analgesic.24 hours postoperativelyThe time to first rescue analgesia was measured from the end to surgery till first dose of paracetamol administrated.

Secondary

MeasureTime frameDescription
Total rescue analgesia consumption24 hours postoperativelyTotal 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
The degree of pain24 hours postoperativelyThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026