Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block

NCT02768493 | Completed

• 1 other identifier: 4-2016-0192
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The recent study revealed that high-volume caudal block caused reduction in cerebral blood flow velocity and cerebral oxygenation. It was supposed to be associated with increased intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before urologic surgery will be divided into high dose group (n=40) and low dose group (n=40). Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after caudal block measured by optic nerve ultrasonography.

Conditions

Orchiopexy; Inguinal Hernioplasty; Hydrocelectomy; Diverticulectomy; Fistula Repair; Penoplasty

Outcome Measures

Primary Outcomes (1)

• The difference in the optic nerve sheath diameter between groups

  1 day

Secondary Outcomes (2)

• The variation in the optic nerve sheath diameter before and after caudal block

  30 minutes

• the difference in the variation of the optic nerve sheath diameter between groups

  30 minutes

Study Arms (2)

low dose group

EXPERIMENTAL

Patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block.

Drug: 1.0 ml/kg of 0.15% ropivacaine

high dose group

ACTIVE COMPARATOR

Patients in the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block.

Drug: 1.5 ml/kg of 0.15% ropivacaine

Interventions

1.0 ml/kg of 0.15% ropivacaine DRUG

Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.

low dose group

1.5 ml/kg of 0.15% ropivacaine DRUG

Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.

high dose group

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients
• weighing less than 16 kg
• who receive caudal block before urologic surgery

You may not qualify if:

• Subjects are ineligible if they have contraindication for caudal block such as infection, coagulopathy, anomaly, or past medical history related to increased intracranial pressure
• ophthalmic disease
• expected operation time is less than 30 minutes
• both parents are unable to communicate or speak Korean.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine

Seoul, 120-752, South Korea

Location

Related Publications (5)

• Girisgin AS, Kalkan E, Kocak S, Cander B, Gul M, Semiz M. The role of optic nerve ultrasonography in the diagnosis of elevated intracranial pressure. Emerg Med J. 2007 Apr;24(4):251-4. doi: 10.1136/emj.2006.040931.

  PMID: 17384377 BACKGROUND

• Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.

  PMID: 21505900 BACKGROUND

• Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.

  PMID: 22258019 BACKGROUND

• Lundblad M, Forestier J, Marhofer D, Eksborg S, Winberg P, Lonnqvist PA. Reduction of cerebral mean blood flow velocity and oxygenation after high-volume (1.5 ml kg(-)(1)) caudal block in infants. Br J Anaesth. 2014 Oct;113(4):688-94. doi: 10.1093/bja/aeu161. Epub 2014 Jun 27.

  PMID: 24972788 BACKGROUND

• Lee B, Koo BN, Choi YS, Kil HK, Kim MS, Lee JH. Effect of caudal block using different volumes of local anaesthetic on optic nerve sheath diameter in children: a prospective, randomized trial. Br J Anaesth. 2017 May 1;118(5):781-787. doi: 10.1093/bja/aex078.

  PMID: 28486629 DERIVED

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)