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Completed

NCT Number: NCT04518215

Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery

Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining effective postoperative analgesia in the paediatric age group is very crucial in terms of future pain perception and chronic pain development. Erector Spinae Plane Block (ESPB) is an interfascial plane block characterized by its ease of application and low complication rates with the introduction of ultrasonography. The aim of this study is to investigate the analgesic effects of ESPB in this particular age-group.

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Key information

Conditions

Paediatric Agnosia Analgesia Anesthesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Surgery

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I - II.
  • Elective open upper abdominal surgeries, e.g., open cholecystectomy, splenectomy, pyeloplasty, renal cysts excision, partial or total nephrectomy.

Exclusion criteria

  • Patient's next of kin refusal.
  • Allergy to local anaesthetics.
  • Infection at the site of injection.
  • Coagulopathy.

Treatment and study plan

Erector Spinae Plain Block

Procedure

Patients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB.

Intra-Venous Analgesia

Procedure

Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.

Primary outcomes

  1. Tramadol consumption.

    Time frame: 24 hours

    Total dose of Tramadol (measured in mg) given intra-venously to the patient post-operatively.

Sponsors and collaborators

Lead sponsor

Nazmy Edward Seif

Other

Registry information

Official study title

Ultrasound-Guided Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery: A Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2020
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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