Adjuvants for Bupivacaine in Brachial Plexus Block in Pediatrics

NCT06180941 | Unknown

• 1 other identifier: brachial plexus block.
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Among paediatrics aging 3:12 who are going to have upper limb surgery,does adding clonidine to bupivacaine improve brachial plexus block outcome in comparison with magnesium sulfate with bupivacaine?

Conditions

Upper Limb Injury

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesia.

  The time(in hours) to first rescue analgesia which is defined as the time since the block performance till the first administration of any rescue analgesia in the postoperative period.

  24 hours

Secondary Outcomes (1)

• Postoperative analgesia.

  24 hours

Study Arms (2)

magnesium sulfate as adjuvant to bupivacaine.

ACTIVE COMPARATOR

Group M: 2mg/kg Magnesium sulfate will be added to 0.5 mL.kg-1 of 0.25% bupivacaine (max 2 mg/kg) with a total volume of 0.5 ml/kg, (according to the spread of local anesthetic surrounding the brachial plexus)

Drug: magnesium sulfate.

clonidine as adjuvant to bupivacaine.

ACTIVE COMPARATOR

Group C: 0.75 μg.kg-1 of clonidine will be added to 0.5 mL.kg-1 of 0.25% bupivacaine (max 2 mg/kg) with a total volume of 0.5 ml/kg, (according to the spread of local anesthetic surrounding the brachial plexus)

Drug: clonidine.

Interventions

magnesium sulfate. DRUG

magnesium sulfate as adjuvant to bupivacaine in supraclavicular brachial plexus block in pediatrics.

magnesium sulfate as adjuvant to bupivacaine.

clonidine. DRUG

clonidine as adjuvant to bupivacaine in supraclavicular brachial plexus block in pediatrics.

clonidine as adjuvant to bupivacaine.

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anaesthesiologists Classes I and II patients.
• within the age group of 3-12 years.
• requiring unilateral upper limb surgery at or below the elbow.

You may not qualify if:

• The patients that have contraindications to regional anaesthetics, previous nerve injuries, history of allergy to study drugs, history of bleeding disorders.
• children with any mental disability which will confound pain assessment or inability to understand the pain scale used in the study.
• patients on anticoagulants.
• patients with any major systemic illness will be excluded from the study.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Arm Injuries

Interventions

Magnesium Sulfate; Clonidine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant physician

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 26, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12