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

South Egypt Cancer Institute

Status and phase: Enrolling; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Levobupivacaine; Procedure: ultra-sound guided transversus abdominis plan block; Drug: magnesium sulphate& levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03979599

Ahmed-SECI-86

Details and patient eligibility

About

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

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

magnesium sulphate& levobupivacaine

Active Comparator group

Description:

Levobupivacaine add to magnisum sulphate

Treatment:

Procedure: ultra-sound guided transversus abdominis plan block

Drug: magnesium sulphate& levobupivacaine

levobupivacaine

Placebo Comparator group

Description:

levobupivacaine

Treatment:

Procedure: ultra-sound guided transversus abdominis plan block

Drug: Levobupivacaine