Upper Limb SurgeryPhase 1NCT04189198
A Comparison of 4% Articaine Versus 0.5%Bupivacaine for Ambulatory Surgery Under Supraclavicular Block
A Phase 1 study testing Articaine and Bupivacaine in people with Upper Limb Surgery and Hand Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
Effect of 2%Articaine versus 5%bupivacaine in pt undergoing short duration surgery in upper limb Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Surgery, Hand Surgery
- What is being tested?
- Articaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2019to 27 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- upper limb surgery
- ganglion removal
- k wiring
- Carapal tunnel
Who cannot join
- Coagulopathy.
- infection at site of injection.
- patient refusal.
- hypersensitivity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Upper Limb Surgery, Hand Surgery
- Being tested
- Articaine, Bupivacaine
- Keywords
- Articaine, Bupivacaine, Ultrasound, Supraclavicular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArticaineDrug
Also called Artinebsa
Supraclavicular block with 30 ml articaine 2%
BupivacaineDrug
Also called Marcaine
Supraclavicular block with 30 ml bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Articaine group | Experimental | Patients in this group are assigned to recieve 30 ml of Articaine 2% Receives: Drug: Articaine |
| Bupivacaine | Experimental | Patients in this group are assigned to recieve 30 ml of bupivacaine 0.5% Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sensory block
By pinprick test from 0 to 2 where 0 no sensory block and 2 complete anesthesia
Measured: Measured in minutes over 24 hours
Durations of motor block
By Bromage scale from 1 to 4 where 1 no motor power and 4 full motor power
Measured: Measured in minutes over 24 hours
Duration of analgesia
Measured by numerical analog scale where 0 no pain and 10 means worst pain
Measured: Measured in minutes over 24 hours
Secondary outcomes (1)
Analgesia
First analgesia required
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start30 Dec 2019
- Primary completion22 Mar 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, simon Halim Armanious, Ain Shams University
- Investigators
- Galal Mo El kadi, Doctor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189198
- Sponsor's protocol ID
- Articaine versus bupivacain
- Status last verified
- Apr 2020
- First submitted
- 3 Dec 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data including primary and secondary outcome for all the participants
Publications
Armanious SH, Abdelhameed GA. A Randomized Controlled Trial: Comparison of 4% Articaine versus 0.5% Bupivacaine for Ambulatory Orthopedic Surgery under Supraclavicular Block. Anesthesiol Res Pract. 2020 Sep 24;2020:2194873. doi: 10.1155/2020/2194873. eCollection 2020.
PubMed 33029135
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial : Comparison of 4% Articaine Versus 0.5% Bupivacaine for Ambulatory Orthopaedic Surgery Under Supraclavicular Block
- ClinicalTrials.gov ID
- NCT04189198
- Acronym / sponsor ID
- Articaine versus bupivacain
- Conditions
- Upper Limb Surgery, Hand Surgery
- Keywords
- Articaine, Bupivacaine, Ultrasound, Supraclavicular block
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 22 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of 2%Articaine versus 5%bupivacaine in pt undergoing short duration surgery in upper limb
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Articaine group | Experimental | Drug: ArticainePatients in this group are assigned to recieve 30 ml of Articaine 2% |
| Bupivacaine | Experimental | Drug: BupivacainePatients in this group are assigned to recieve 30 ml of bupivacaine 0.5% |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- upper limb surgery
- ganglion removal
- k wiring
- Carapal tunnel
Key exclusion criteria (4 listed)
- Coagulopathy.
- infection at site of injection.
- patient refusal.
- hypersensitivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArticaineAlso: ArtinebsaSupraclavicular block with 30 ml articaine 2% | Drug | Articaine group |
| BupivacaineAlso: MarcaineSupraclavicular block with 30 ml bupivacaine 0.5% | Drug | Bupivacaine |
Primary outcome
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
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
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
1 secondary outcome
Analgesia
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Derived from this study: PubMed 33029135Armanious SH, Abdelhameed GA. A Randomized Controlled Trial: Comparison of 4% Articaine versus 0.5% Bupivacaine for Ambulatory Orthopedic Surgery under Supraclavicular Block. Anesthesiol Res Pract. 2020 Sep 24;2020:2194873. doi: 10.1155/2020/2194873. eCollection 2020.
- Individual participant dataSharing planned: Yes. All data including primary and secondary outcome for all the participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galal Mo El kadi, Doctor study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Articaine and Bupivacaine in people with Upper Limb Surgery and Hand Surgery, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of sensory block (time frame: Measured in minutes over 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04189198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.