Local AnaesthesiaNCT02857686
Forearm Tourniquet With Small Dose Intravenous Lidocaine
A study testing intravenous regional anaesthesia and forearm IVRA in people with Local Anaesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
The safety and effectiveness of the "mini-dose" Bier block, a technique of i.v. regional anesthesia using low-dose lidocaine (1.5 mg/kg) without routine premedication, was evaluated in the emergency department treatment of pediatric upper extremity fractures and dislocations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Local Anaesthesia
- What is being tested?
- intravenous regional anaesthesia and forearm IVRA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Mar 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA(American society of anesthesia) I, II , consent, forearm or arm surgery
Who cannot join
- ASA(American society of anesthesia) III or more, allergy, refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Forearm Tourniquet With Small Dose Intravenous Lidocaine as a Substitute to Conventional Intravenous Regional Anaesthesia
The safety and effectiveness of the "mini-dose" Bier block, a technique of i.v. regional anesthesia using low-dose lidocaine (1.5 mg/kg) without routine premedication, was evaluated in the emergency department treatment of pediatric upper extremity fractures and dislocations.
Read the detailed description
this study aimed at comparing IVRA with small dose lidocaine and forearm tourniquet with conventional IVRA with arm tourniquet and usual lidocaine dose
- Conditions
- Local Anaesthesia
- Being tested
- intravenous regional anaesthesia, forearm IVRA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous regional anaesthesiaProcedure or surgery
tourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg
forearm IVRAProcedure or surgery
tourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg
| Study group | Role | What they receive |
|---|---|---|
| arm intravenous regional anesthesia | Active comparator | tourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg Receives: Procedure: intravenous regional anaesthesia |
| forearm intravenous regional anesthesia | Experimental | tourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg Receives: Procedure: forearm IVRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
visual analogue scale
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857686
- Sponsor's protocol ID
- mini IVRA
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forearm Tourniquet With Small Dose Intravenous Lidocaine as a Substitute to Conventional Intravenous Regional Anaesthesia
- ClinicalTrials.gov ID
- NCT02857686
- Acronym / sponsor ID
- mini IVRA
- Conditions
- Local Anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- 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.
The safety and effectiveness of the "mini-dose" Bier block, a technique of i.v. regional anesthesia using low-dose lidocaine (1.5 mg/kg) without routine premedication, was evaluated in the emergency department treatment of pediatric upper extremity fractures and dislocations.
Detailed description
this study aimed at comparing IVRA with small dose lidocaine and forearm tourniquet with conventional IVRA with arm tourniquet and usual lidocaine dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm intravenous regional anesthesia | Active comparator | Procedure: intravenous regional anaesthesiatourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg |
| forearm intravenous regional anesthesia | Experimental | Procedure: forearm IVRAtourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA(American society of anesthesia) I, II , consent, forearm or arm surgery
Key exclusion criteria (1 listed)
- ASA(American society of anesthesia) III or more, allergy, refusal
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 |
|---|---|---|
| intravenous regional anaesthesiatourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg | Procedure or surgery | arm intravenous regional anesthesia |
| forearm IVRAtourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg | Procedure or surgery | forearm intravenous regional anesthesia |
Primary outcome
pain
Time frame: 2 hours
visual analogue scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous regional anaesthesia and forearm IVRA in people with Local Anaesthesia, run by Cairo 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan Ali, lecturer (1001733687, hassan364@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2016.