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

NCT03979599 | Unknown Phase 3

• 1 other identifier: Ahmed-SECI-86
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

TAP, magnisum sulphate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

magnesium sulphate& levobupivacaine

ACTIVE COMPARATOR

Levobupivacaine add to magnisum sulphate

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

levobupivacaine

PLACEBO COMPARATOR

levobupivacaine

Procedure: ultra-sound guided transversus abdominis plan block; Drug: Levobupivacaine

Interventions

ultra-sound guided transversus abdominis plan block PROCEDURE

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

levobupivacaine; magnesium sulphate& levobupivacaine

magnesium sulphate& levobupivacaine DRUG

magnesium sulphate\& levobupivacaine

magnesium sulphate& levobupivacaine

Levobupivacaine DRUG

levobupivacaine

levobupivacaine

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

south Egypt cancer institute

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ahmed K Sayed, specialist

CONTACT

01010677881; ahmedkamal86anathesia@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: all participant will be blinded to the study drugs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 7, 2019
• Study Start: April 15, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

EG (1)