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Caudal Block With Bupivacaine and Dexmedetomidine Versus TAP Block With Bupivacaine Alone for Postoperative Analgesia in Pediatric Undergoing Infraumbical Surgeries

NCT ID: NCT06183073

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-02

Study Completion Date

2024-02-01

Brief Summary

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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

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Caudal block with bupivacaine and dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

caudal block

Intervention Type PROCEDURE

bupivacaine 0.25% in a dose of (1 ml / kg)

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine 1μg/ kg.

Bupivacain

Intervention Type DRUG

bupivacaine 0.25% in a dose of (0.5 ml / kg

TAP block with bupivacaine

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

Group Type ACTIVE_COMPARATOR

TAP

Intervention Type PROCEDURE

analgesia

Bupivacain

Intervention Type DRUG

bupivacaine 0.25% in a dose of (0.5 ml / kg

Interventions

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caudal block

bupivacaine 0.25% in a dose of (1 ml / kg)

Intervention Type PROCEDURE

Dexmedetomidine

dexmedetomidine 1μg/ kg.

Intervention Type DRUG

TAP

analgesia

Intervention Type PROCEDURE

Bupivacain

bupivacaine 0.25% in a dose of (0.5 ml / kg

Intervention Type DRUG

Other Intervention Names

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bupivacaine

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Fouad Soliman

Lecturer of Anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fouad I Soliman, MD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

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Fouad Ibrahim Soliman

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Fouad I Soliman, MD

Role: CONTACT

Phone: 01113815186

Email: [email protected]

Facility Contacts

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Fouad I Soliman, MD

Role: primary

Other Identifiers

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2009

Identifier Type: -

Identifier Source: org_study_id