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

April 27, 2020 updated by: simon Halim Armanious, Ain Shams University

A Randomized Controlled Trial : Comparison of 4% Articaine Versus 0.5% Bupivacaine for Ambulatory Orthopaedic Surgery Under Supraclavicular Block

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasya
      • Cairo, Abbasya, Egypt
        • Ain Shams University hosptal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • upper limb surgery
  • ganglion removal
  • k wiring
  • Carapal tunnel

Exclusion Criteria:

  • Coagulopathy.
  • infection at site of injection.
  • patient refusal.
  • hypersensitivity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of sensory block
Time Frame: Measured in minutes over 24 hours
By pinprick test from 0 to 2 where 0 no sensory block and 2 complete anesthesia
Measured in minutes over 24 hours
Durations of motor block
Time Frame: Measured in minutes over 24 hours
By Bromage scale from 1 to 4 where 1 no motor power and 4 full motor power
Measured in minutes over 24 hours
Duration of analgesia
Time Frame: Measured in minutes over 24 hours
Measured by numerical analog scale where 0 no pain and 10 means worst pain
Measured in minutes over 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia
Time Frame: 24 hours
First analgesia required
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 30, 2019

Primary Completion (ACTUAL)

March 22, 2020

Study Completion (ACTUAL)

March 27, 2020

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (ACTUAL)

December 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Articaine versus bupivacain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data including primary and secondary outcome for all the participants

IPD Sharing Time Frame

Within 6 month after end of study

IPD Sharing Access Criteria

Upon request from Corresponding Author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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