Back to resultsSafety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
Primary Purpose
Postoperative Pain
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
ultra-sound guided transversus abdominis plan block
magnesium sulphate& levobupivacaine
Levobupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring TAP, magnisum sulphate
Eligibility Criteria
Inclusion Criteria:
- patients with American society of anesthesiology (ASA) Ӏ and ӀӀ physical status, aged from 1 to 7 years old and their weight 10 to 30 Kg of both sex will undergo abdominal cancer surgery will be enrolled.
Exclusion Criteria:
- Children with local infection, hemorrhagic disorders, drug hypersensitivity or allergy to the studied drugs, muscular disorders, central and peripheral neuropathy, significant organ dysfunction, cardiac dysrrhythmia, congenital heart diseases and unconscious or mentally retarded patients will be excluded from this study.
Sites / Locations
- south Egypt cancer instituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
magnesium sulphate& levobupivacaine
levobupivacaine
Arm Description
Levobupivacaine add to magnisum sulphate
levobupivacaine
Outcomes
Primary Outcome Measures
postoperative pain management
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03979599
First Posted
June 4, 2019
Last Updated
April 18, 2023
Sponsor
South Egypt Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03979599
Brief Title
Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
Official Title
Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
To study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
TAP, magnisum sulphate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Group A (control group): patients will receive levobupivacaine 0.25% . Group B (magnesium sulphate group): patients will receive levobupivacaine 0.25% + MgSo4 .
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
all participant will be blinded to the study drugs.
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
magnesium sulphate& levobupivacaine
Arm Type
Active Comparator
Arm Description
Levobupivacaine add to magnisum sulphate
Arm Title
levobupivacaine
Arm Type
Placebo Comparator
Arm Description
levobupivacaine
Intervention Type
Procedure
Intervention Name(s)
ultra-sound guided transversus abdominis plan block
Intervention Description
comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine
Intervention Type
Drug
Intervention Name(s)
magnesium sulphate& levobupivacaine
Intervention Description
magnesium sulphate& levobupivacaine
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Intervention Description
levobupivacaine
Primary Outcome Measure Information:
Title
postoperative pain management
Description
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.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed K Sayed, specialist
Phone
01010677881
Email
ahmedkamal86anathesia@gmail.com
Facility Information:
Facility Name
south Egypt cancer institute
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed K SAyed, specialist
Email
ahmedkamal86anathesia@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
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