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A Comparison of 4% Articaine Versus 0.5%Bupivacaine for Ambulatory Surgery Under Supraclavicular Block

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04189198
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
2.9
Actual Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effect of 2%Articaine versus 5%bupivacaine in pt undergoing short duration surgery in upper limb

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The investigator aim to compare Articaine 2% versus bupivacaine 0.5% in patient undergoing upper limb procedure under ultrasound guided supraclavicular block as regard onset and duration of sensory and motor block

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Health Services Research
Official Title:
A Randomized Controlled Trial : Comparison of 4% Articaine Versus 0.5% Bupivacaine for Ambulatory Orthopaedic Surgery Under Supraclavicular Block
Actual Study Start Date :
Dec 30, 2019
Actual Primary Completion Date :
Mar 22, 2020
Actual Study Completion Date :
Mar 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Articaine group

Patients in this group are assigned to recieve 30 ml of Articaine 2%

Drug: Articaine
Supraclavicular block with 30 ml articaine 2%
Other Names:
  • Artinebsa

    		•
    Experimental: Bupivacaine

    Patients in this group are assigned to recieve 30 ml of bupivacaine 0.5%

    Drug: Bupivacaine
    Supraclavicular block with 30 ml bupivacaine 0.5%
    Other Names:
  • Marcaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of sensory block [Measured in minutes over 24 hours]

      By pinprick test from 0 to 2 where 0 no sensory block and 2 complete anesthesia

    2. Durations of motor block [Measured in minutes over 24 hours]

      By Bromage scale from 1 to 4 where 1 no motor power and 4 full motor power

    3. Duration of analgesia [Measured in minutes over 24 hours]

      Measured by numerical analog scale where 0 no pain and 10 means worst pain

    Secondary Outcome Measures

    1. Analgesia [24 hours]

      First analgesia required

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • upper limb surgery

    • ganglion removal

    • k wiring

    • Carapal tunnel

    Exclusion Criteria:

    • Coagulopathy.

    • infection at site of injection.

    • patient refusal.

    • hypersensitivity.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University hosptal Cairo Abbasya Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Study Director: Galal Mo El kadi, Doctor, Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    simon Halim Armanious, Principal investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT04189198
    Other Study ID Numbers:
    • Articaine versus bupivacain
    First Posted:
    Dec 6, 2019
    Last Update Posted:
    Apr 28, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by simon Halim Armanious, Principal investigator, Ain Shams University
    Articaine
    Bupivacaine
    Ultrasound
    Supraclavicular block
    Additional relevant MeSH terms:
    Bupivacaine
    Carticaine

    Study Results

    No Results Posted as of Apr 28, 2020