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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03979599

Enrollment

Registered

2019-06-07

Start date

2019-04-15

Completion date

2023-06-30

Last updated

2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

TAP, magnisum sulphate

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

Interventions

PROCEDUREultra-sound guided transversus abdominis plan block

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

DRUGmagnesium sulphate& levobupivacaine

magnesium sulphate& levobupivacaine

DRUGLevobupivacaine

levobupivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

all participant will be blinded to the study drugs.

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

1 Years to 7 Years

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

Design outcomes

Primary

Measure	Time frame	Description
postoperative pain management	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.

Countries

Egypt

Contacts

Primary ContactAhmed K Sayed, specialist

ahmedkamal86anathesia@gmail.com01010677881

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026