NCT03482947

Brief Summary

Caudal epidural block is a well-established and commonly performed regional neuraxial technique for providing intraoperative and postoperative analgesia in children scheduled for lower abdomen/perineal surgical interventions. Although the efficacy and safety of Caudal epidural block are fairly high, the associated complications, such as inadvertent dural puncture, unwarranted motor blockade of the lower limbs, and disturbance of bladder function, limit its use. Furthermore, a major limitation of an uncomplicated Caudal epidural block when administered as a "single-shot" technique is its brief duration of action (up to 6 hours), which makes administration of additional analgesics necessary .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

March 18, 2018

Last Update Submit

September 10, 2021

Conditions

Analgesia, Epidural

Keywords

Dexmedetomidinepediatrics; postoperative;Analgesia; caudal

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia.

    time for first analgesic request

    24 hours

Secondary Outcomes (2)

  • Postoperative analgesia

    24 hours

  • Postoperative pain

    24 hours

Study Arms (2)

TAP

EXPERIMENTAL

ultrasonography-guided transversus abdominis plane block administration of (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).

Drug: ultrasonography-guided TAP block

Caudal

EXPERIMENTAL

Caudal epidural block administration of (1 mL/kg of bupivacaine 0.25% \&1 μ/kg dexmedetomidine

Drug: Caudal epidural block

Interventions

ultrasonography-guided TAP blockDRUG

(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).

TAP
Caudal epidural blockDRUG

(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine)

Caudal

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients 2-8 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

Related Publications (4)

  • Tsui BC, Berde CB. Caudal analgesia and anesthesia techniques in children. Curr Opin Anaesthesiol. 2005 Jun;18(3):283-8. doi: 10.1097/01.aco.0000169236.91185.5b.

    PMID: 16534352RESULT

  • Koul A, Pant D, Sood J. Caudal clonidine in day-care paediatric surgery. Indian J Anaesth. 2009 Aug;53(4):450-4.

    PMID: 20640207RESULT

  • Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.

    PMID: 25393589RESULT

  • Menzies R, Congreve K, Herodes V, Berg S, Mason DG. A survey of pediatric caudal extradural anesthesia practice. Paediatr Anaesth. 2009 Sep;19(9):829-36. doi: 10.1111/j.1460-9592.2009.03116.x.

    PMID: 19691690RESULT

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 29, 2018

Study Start

April 1, 2018

Primary Completion

December 1, 2019

Study Completion

October 1, 2020

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations

EG(1)