Analgesic Effect of Ultrasound Guided Errector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Open Renal Surgeries.

NCT05289401 | Completed

• 1 other identifier: MD-323-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

comparison between the erector spinae block and caudal block with the aid of the of ultra sound in children as regard time of request of rescue analgesia , degree of intra and post operative pain relief , effect of hemodynamic stability and incidences of complication in open renal surgeries .

Conditions

Analgesia , Open Renal Surgeries

Keywords

erector spinae block , caudal block

Outcome Measures

Primary Outcomes (1)

• primary outcome

  The first time to require rescue analgesia in minutes (from the time of erector spinae block or caudal injection to the first registration of CHEOPS pain score more than 6)

  at the time of transfer from PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours postoperatively

Secondary Outcomes (1)

• secondary outcome

  at time of transfer to PACU and then at 1, 2, 3, 4, 6, 8 and 12 hours.

Study Arms (2)

ESPB

ACTIVE COMPARATOR

Unilateral erector spinae block will be performed in the lateral position . 0.5 mL/Kg of bupivacaine 0.125% will be injected taking care not to exceed the maximum recommended dose (2 mg/kg of bupivacaine)

Other: ultrasound guided blocks

CB

ACTIVE COMPARATOR

caudal block performed in lateral position . bolus of 1.2 ml/Kg bupivacaine 0.125% .

Other: ultrasound guided blocks

Interventions

ultrasound guided blocks OTHER

Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric

CB; ESPB

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients 2-6 years old.
• American society of anesthesiologists classification (ASA) I and II .
• Patients undergoing unilateral open renal surgeries.

You may not qualify if:

• Refusal of block.
• Bleeding disorders (platelets count \< 150,000; INR \>1.5; PC\< 60%).
• Skin lesion, wounds or infection at the puncture site.
• Known allergy to local anesthetic drugs.
• Contraindications to neuraxial block as sepsis, severe aortic stenosis, increased intracranial pressure.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, C, 11211, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: March 21, 2022
• Study Start: January 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

EG (1)