Femoral FracturesPhase 3NCT02658760
Dexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults
A Phase 3 study testing Dexmedetomidine and Bupivacaine in people with Femoral Fractures, run by Hamidreza Mahboobi at 1 site in Iran.
Trial summary
Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Dexmedetomidine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jun 2015to Dec 2016
- Phase
- Phase 3
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults with femural fracture
Who cannot join
- Hypersensitivity to drugs
- Neurological diseases
- Coagulation abnormalities
- Infection at the site of block
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Mohammadi hospital
Bandar Abbas, Hormozgan, 79176
Hamidreza Mahboobi, 09809364300250, hamidrezamahboobi@yahoo.com
Hamidreza Mahboobi
About this study
Official title: Comparison of Dexmedetomidine and Bupivacaine With Bupivacaine Alone on the Quality of Ultrasonography Guided Fascia Iliaca Compartment Block in Adults Undergoing Femur Fracture Fixation Surgery
Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014.
- Conditions
- Femoral Fractures
- Being tested
- Dexmedetomidine, Bupivacaine
- Keywords
- Femoral Fractures
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
dexmedetomidine plus placebo
BupivacaineDrug
dexmedetomidine and Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | 30cc of 0.25% bupivacaine Receives: Drug: Bupivacaine |
| Dexmedetomidine and bupivacaine | Active comparator | 30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine Receives: Drug: Dexmedetomidine; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
A point between 0 and 10 based on patient report
Measured: 24 hours
Secondary outcomes (3)
Respiratory depression
respiratory rate < 12/min
Measured: 24 hours
Hypotension
Systolic blood pressure < 90 mmHg
Measured: 24 hours
Baradycardia
Heart rate < 60/min
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 posted20 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamidreza Mahboobi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamidreza Mahboobi, Hormozgan University of Medical Sciences
- Investigators
- Nasim Abdi, Principal investigator, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658760
- Sponsor's protocol ID
- Hums.Rec.1394.74
- Status last verified
- Oct 2016
- First submitted
- 15 Jan 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexmedetomidine and Bupivacaine With Bupivacaine Alone on the Quality of Ultrasonography Guided Fascia Iliaca Compartment Block in Adults Undergoing Femur Fracture Fixation Surgery
- ClinicalTrials.gov ID
- NCT02658760
- Acronym / sponsor ID
- Hums.Rec.1394.74
- Conditions
- Femoral Fractures
- Keywords
- Femoral Fractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hamidreza MahboobiUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Jan 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.
Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: Bupivacaine30cc of 0.25% bupivacaine |
| Dexmedetomidine and bupivacaine | Active comparator | Drug: Dexmedetomidine, Drug: Bupivacaine30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with femural fracture
Key exclusion criteria (4 listed)
- Hypersensitivity to drugs
- Neurological diseases
- Coagulation abnormalities
- Infection at the site of block
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 |
|---|---|---|
| Dexmedetomidinedexmedetomidine plus placebo | Drug | Dexmedetomidine and bupivacaine |
| Bupivacainedexmedetomidine and Bupivacaine | Drug | Bupivacaine, Dexmedetomidine and bupivacaine |
Primary outcome
Pain
Time frame: 24 hours
A point between 0 and 10 based on patient report
3 secondary outcomes
Respiratory depression
Time frame: 24 hours
Hypotension
Time frame: 24 hours
Baradycardia
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Nasim Abdi principal investigator
Hormozgan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Bupivacaine in people with Femoral Fractures, run by Hamidreza Mahboobi at 1 site in Iran.
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 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: status not confirmed, as of the sponsor's last update on 13 Oct 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 Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hamidreza Mahboobi (9172121995 ext. +98, hamidrezamahboobi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 24 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 13 Oct 2016.