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

December 26, 2023 updated by: Fouad Soliman, Sohag University

Analgesic Efficacy of Transversus Abdominis Plane Block Versus Caudal Dexmedetomidine in Children Undergoing Abdominal Surgeries

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Caudal block with bupivacaine and dexmedetomidine
Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.
Procedure: caudal block
bupivacaine 0.25% in a dose of (1 ml / kg)
Other Names:
  • bupivacaine
Drug: Dexmedetomidine
dexmedetomidine 1μg/ kg.
Drug: Bupivacain
bupivacaine 0.25% in a dose of (0.5 ml / kg
Active Comparator: TAP block with bupivacaine
TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).
Drug: Bupivacain
bupivacaine 0.25% in a dose of (0.5 ml / kg
Procedure: TAP
analgesia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate (HR)
Time Frame: 12 hours
Hemodynamic assessment
12 hours
systolic Blood Pressure (BP)
Time Frame: 12 hours
Hemodynamic assessment
12 hours
diastolic Blood Pressure (BP)
Time Frame: 12 hours
Hemodynamic assessment
12 hours
SpO2 -Hemodynamic assessment
Time Frame: 12 hours
12 hours
Total paracetamol consumption
Time Frame: 12 hours
12 hours
post operative pain score
Time Frame: 12 hours
post operative pain score upon arrival to recovery room and then 2, 4,6, 8 , and 12 hours after surgery using Faces pain scale-revised.
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Fouad I Soliman, MD, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2023

Primary Completion (Estimated)

January 14, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

December 27, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009 (Organization for Autism Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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