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

Phase 3

Recruiting

• Conditions: Postoperative Pain
• Interventions: Procedure: ultra-sound guided transversus abdominis plan block; Drug: magnesium sulphate& levobupivacaine; Drug: Levobupivacaine

• Registration Number: NCT03979599
• Lead Sponsor: South Egypt Cancer Institute

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

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
magnesium sulphate& levobupivacaine	magnesium sulphate& levobupivacaine	Levobupivacaine add to magnisum sulphate
levobupivacaine	ultra-sound guided transversus abdominis plan block	levobupivacaine
magnesium sulphate& levobupivacaine	ultra-sound guided transversus abdominis plan block	Levobupivacaine add to magnisum sulphate
levobupivacaine	Levobupivacaine	levobupivacaine

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

south Egypt cancer institute; 🇪🇬 Assiut, Egypt