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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03979599
Other study ID # Ahmed-SECI-86
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 15, 2019
Est. completion date June 30, 2023

Study information

Verified date April 2023
Source South Egypt Cancer Institute
Contact Ahmed K Sayed, specialist
Phone 01010677881
Email ahmedkamal86anathesia@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 30, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Year to 7 Years
Eligibility Inclusion Criteria: - patients with (ASA) ? and ?? 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

Study Design


Related Conditions & MeSH terms


Intervention

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
Levobupivacaine
levobupivacaine

Locations

Country Name City State
Egypt south Egypt cancer institute Assiut

Sponsors (1)

Lead Sponsor Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. one day
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