Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery

Overview

To study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 1, 2023

Detailed Description

In this randomized study, patients with (ASA) Ӏ and ӀӀ, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled. A written informed consent from all parents are obtained

Interventions

  • Procedure: ultra-sound guided transversus abdominis plan block
    • comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine
  • Drug: magnesium sulphate& levobupivacaine
    • magnesium sulphate& levobupivacaine
  • Drug: Levobupivacaine
    • levobupivacaine

Arms, Groups and Cohorts

  • Active Comparator: magnesium sulphate& levobupivacaine
    • Levobupivacaine add to magnisum sulphate
  • Placebo Comparator: levobupivacaine
    • levobupivacaine

Clinical Trial Outcome Measures

Primary Measures

  • postoperative pain management
    • Time Frame: one day
    • pain will be assessed using FLACC score.The Face, Legs, Activity, Cry, Consolability (FLACC) pain score with its 0 – 10 score range will be used to assess pain immediately postoperative and then at 2, 4, 6, 8, 12, 18 and 24 hours in the postoperative period.

Participating in This Clinical Trial

Inclusion Criteria

  • patients with (ASA) Ӏ and ӀӀ physical status, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled. Exclusion Criteria:

  • Children with infection, hemorrhagic disorders, hypersensitivity to the studied drugs, muscular disorders, central and peripheral neuropathy, organ dysfunction, cardiac problems and unconscious or mentally retarded patients will be excluded

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 7 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • South Egypt Cancer Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Kamal Sayed, Principal Investigator – South Egypt Cancer Institute
  • Overall Contact(s)
    • Ahmed K Sayed, specialist, 01010677881, ahmedkamal86anathesia@gmail.com

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