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

• Sponsor: Ataturk University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05216211
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.7
• Patients Per Site Per Month: 10.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Intracranial Hypertension	Drug: Bupivacaine Hydrochloride	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
• Actual Study Start Date: Dec 9, 2021
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group Caudal Caudal block with 1 ml / kg, % 0.25 bupivacaine	Drug: Bupivacaine Hydrochloride; 1 ml / kg, % 0.25 bupivacaine
No Intervention: Group Control No intervention

Outcome Measures

Primary Outcome Measures

1. Optic Nerve Diameter [First minute]

   Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes

2. Optic Nerve Diameter [5th minutes]

   Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes

3. Optic Nerve Diameter [15th minutes]

   Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes

4. Optic Nerve Diameter [30th minutes]

   Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ataturk University School of Medicine	Erzurum	Yakutiye	Turkey	25100

Sponsors and Collaborators

• Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmet Murat Yayik, Principal Investigator, Ataturk University
• ClinicalTrials.gov Identifier: NCT05216211
• Other Study ID Numbers: Optic nerve Caudal
• First Posted: Jan 31, 2022
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intracranial Hypertension; Bupivacaine

Study Results

No Results Posted as of Mar 2, 2022