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OpenTrials
Completed

NCT Number: NCT05216211

The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients

Caudal epidural block has been a widely used regional anesthesia method, especially in pediatric surgery, to provide intraoperative and postoperative analgesia. Studies on non-invasive methods used for intracranial pressure measurement have shown that optic nerve sheath diameter is related to intracranial pressure. Optic nerve sheath diameter measurement has high diagnostic accuracy for detecting increased intracranial pressure in children. The aim of the study is to investigate the effect of the caudal block on optic nerve sheath diameter in pediatric patients.

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Key information

Conditions

Postoperative Pain Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University School of Medicine

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • circumcision,
  • inguinal hernia,
  • undescended testis,
  • hydrocele operation

Exclusion criteria

  • neurological or spinal anomaly,
  • coagulopathy
  • allergy to local anesthetics,
  • local infection in the area to be intervention,
  • with increased intracranial pressure
  • children with any ophthalmic pathology

Treatment and study plan

Bupivacaine Hydrochloride

Drug

1 ml / kg, % 0.25 bupivacaine

Primary outcomes

  1. Optic Nerve Diameter

    Time frame: First minute

    Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes

  2. Optic Nerve Diameter

    Time frame: 5th minutes

    Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes

  3. Optic Nerve Diameter

    Time frame: 15th minutes

    Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes

  4. Optic Nerve Diameter

    Time frame: 30th minutes

    Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2022
Registry last updated
Dec 23, 2022

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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