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

NCT ID: NCT03979599

Last Updated: 2023-04-19

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A (control group): patients will receive levobupivacaine 0.25% . Group B (magnesium sulphate group): patients will receive levobupivacaine 0.25% + MgSo4 .
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
all participant will be blinded to the study drugs.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

magnesium sulphate& levobupivacaine

Levobupivacaine add to magnisum sulphate

Group Type ACTIVE_COMPARATOR

ultra-sound guided transversus abdominis plan block

Intervention Type PROCEDURE

comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine

magnesium sulphate& levobupivacaine

Intervention Type DRUG

magnesium sulphate\& levobupivacaine

levobupivacaine

levobupivacaine

Group Type PLACEBO_COMPARATOR

ultra-sound guided transversus abdominis plan block

Intervention Type PROCEDURE

comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine

Levobupivacaine

Intervention Type DRUG

levobupivacaine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultra-sound guided transversus abdominis plan block

comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine

Intervention Type PROCEDURE

magnesium sulphate& levobupivacaine

magnesium sulphate\& levobupivacaine

Intervention Type DRUG

Levobupivacaine

levobupivacaine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

South Egypt Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Kamal Sayed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

south Egypt cancer institute

Asyut, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed K Sayed, specialist

Role: CONTACT

01010677881

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahmed K SAyed, specialist

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ahmed-SECI-86

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Magnesium Sulphate in Oblique Subcostal TAP Block
NCT06148168 NOT_YET_RECRUITING PHASE2/PHASE3