Sequelae of Fracture of Forearm and Upper ArmPhase 4NCT02049970
Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade
A Phase 4 study testing dexmedetomidine and bupivacaine in people with Sequelae of Fracture of Forearm and Upper Arm, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine providing prolonged analgesia after surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sequelae of Fracture of Forearm and Upper Arm
- What is being tested?
- dexmedetomidine and bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Nov 2014
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 age
- unwanted general anaesthesia
- ASA 1-2
- single forearm, arm surgery
Who cannot join
- major psychiatric problems
- major neurologic deficits
- coagulopathy
- drug allergies
- chronic analgesic used
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Medical Faculty
Kayseri, 38039
About this study
Official title: Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade for Forearm Surgery.
the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine providing prolonged analgesia after surgery.
Read the detailed description
Anaesthesia for surgeries to the upper extremity commonly is provided using brachial plexus anaesthesia.Various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexmedetomidine are frequently used for this purpose. this study was conducted to compare the effects of adding dexmedetomidine to local anaesthetics in the supraclavicular brachial plexus block by using nerve stimulators and ultrasonography guided. dexmedetomidine has also been found the prolong the duration of bupivacaine infraclavicular brachial plexus block.
- Being tested
- dexmedetomidine, bupivacaine
- Keywords
- Supraclavicular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called precedex
1 ml 100 mcg dexmedetomidine+ 15 ml 0.25 % bupivacaine are applied around brachial plexus
bupivacaineDrug
Also called marcaine
30 ml 0.25 % bupivacaine is applied around brachial plexus
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine and bupivacaine | Experimental | Bupivacaine 50 mg and dexmedetomidine 1 microgram/kg Receives: Drug: dexmedetomidine; Drug: bupivacaine |
| Bupivacaine and placebo | Experimental | Bupivacaine 100 mg and SF 10 ml Receives: Drug: dexmedetomidine; Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of sensorial block
pin-prick test
Measured: postoperative 1 day
Secondary outcomes (1)
the first time analgesic required
Measured: postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sequelae of Fracture of Forearm and Upper ArmStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Aksu, TC Erciyes University
- Investigators
- Recep Aksu, Study director, Ass.Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049970
- Sponsor's protocol ID
- 2013/107
- Status last verified
- Nov 2014
- First submitted
- 28 Jan 2014
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade for Forearm Surgery.
- ClinicalTrials.gov ID
- NCT02049970
- Acronym / sponsor ID
- 2013/107
- Keywords
- Supraclavicular block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Jan 2014 (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 aim of this study was effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine providing prolonged analgesia after surgery.
Detailed description
Anaesthesia for surgeries to the upper extremity commonly is provided using brachial plexus anaesthesia.Various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexmedetomidine are frequently used for this purpose. this study was conducted to compare the effects of adding dexmedetomidine to local anaesthetics in the supraclavicular brachial plexus block by using nerve stimulators and ultrasonography guided. dexmedetomidine has also been found the prolong the duration of bupivacaine infraclavicular brachial plexus block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine and bupivacaine | Experimental | Drug: dexmedetomidine, Drug: bupivacaineBupivacaine 50 mg and dexmedetomidine 1 microgram/kg |
| Bupivacaine and placebo | Experimental | Drug: dexmedetomidine, Drug: bupivacaineBupivacaine 100 mg and SF 10 ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 age
- unwanted general anaesthesia
- ASA 1-2
- single forearm, arm surgery
Key exclusion criteria (5 listed)
- major psychiatric problems
- major neurologic deficits
- coagulopathy
- drug allergies
- chronic analgesic used
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 |
|---|---|---|
| dexmedetomidineAlso: precedex1 ml 100 mcg dexmedetomidine+ 15 ml 0.25 % bupivacaine are applied around brachial plexus | Drug | Bupivacaine and placebo, dexmedetomidine and bupivacaine |
| bupivacaineAlso: marcaine30 ml 0.25 % bupivacaine is applied around brachial plexus | Drug | Bupivacaine and placebo, dexmedetomidine and bupivacaine |
Primary outcome
the duration of sensorial block
Time frame: postoperative 1 day
pin-prick test
1 secondary outcome
the first time analgesic required
Time frame: postoperative 1 day
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 10 Nov 2014.
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.
Recep Aksu study director
Ass.Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine and bupivacaine in people with Sequelae of Fracture of Forearm and Upper Arm, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 5 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 10 Nov 2014. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the duration of sensorial block (time frame: postoperative 1 day). 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 10 Nov 2014.