Caudal Block With Bupivacaine and Dexmedetomidine Versus... | NCT06183073

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2023Actual

Primary Completion Date

Jan 14, 2024Estimated

Completion Date

Feb 1, 2024Estimated

First Submitted Date

Dec 13, 2023

First Submission Date that Met QC Criteria

Dec 26, 2023

First Posted Date

Dec 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2023

Last Update Posted Date

Dec 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. Children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each):

Group D: Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.

Group T: TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Caudal block with bupivacaine and dexmedetomidine	Active Comparator	Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.	Procedure: caudal block Drug: Dexmedetomidine Drug: Bupivacain
TAP block with bupivacaine	Active Comparator	TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).	Procedure: TAP Drug: Bupivacain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
caudal block	Procedure	bupivacaine 0.25% in a dose of (1 ml / kg)	Caudal block with bupivacaine and dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1st analgesic requirement	Time for first analgesic request (paracetamol intravenously 15 mg/kg) (h)	12 hours

Secondary Outcomes

Measure	Description	Time Frame
Heart rate (HR)	Hemodynamic assessment	12 hours
systolic Blood Pressure (BP)	Hemodynamic assessment	12 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 3-9 years old
Physical status I and II class of the American Society of Anesthesiologists (ASA)
Unilateral elective surgeries below the umbilicus

Exclusion Criteria:

Parents or legal guardian refusal.
History of developmental delay or mental retardation
Contraindications to regional anesthesia as known or suspected coagulopathy, a known allergy to any of the study drugs, signs of infection at the site of caudal block.
Hemodynamic unstable patient.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fouad I Soliman, MD	Contact	01113815186		fouad_soliman@med.sohag.edu.eg

Overall Officials

Name	Affiliation	Role
Fouad I Soliman, MD	Sohag University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fouad Ibrahim Soliman	Recruiting	Sohag		52514	Egypt

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds