AnalgesiaPhase 4NCT03385967
Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block
A Phase 4 study testing Dexmedetomidine and ropivacaine in people with Analgesia and Pain, Acute, run by University of Florida.
Trial summary
This is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10), Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Pain, Acute, Peripheral Nerve Block
- What is being tested?
- Dexmedetomidine and ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Dec 2019
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age-18years and above
- Both male and female patients
- BMI->18
- Elective Subacute upper extremity fractures
Who cannot join
- Chronic pain patients (Pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.)
- Patients with drug abuse history in the past 6 months
- ESRD
- Hepatic failure
About this study
Official title: A Randomized, Prospective, Double Blind Clinical Trial to Investigate the Increase in Duration of Analgesia With Addition of 0.25mcg/kg of Dexmedetomidine (DEX) to 25 ml of 0.5%Ropivacaine in Supraclavicular Brachial Plexus Block.
This is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10), Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. This study mainly aims to investigate whether addition of dexmedetomidine helps in increasing the duration of analgesia.
Read the detailed description
In our institute ropivacaine is used for all the peripheral nerve blocks. This a prospective, randomized, double blind clinical trial study comparing the addition of dexmedetomidine vs ropivacaine alone in brachial plexus nerve block. After screening the patient with the inclusion criteria, an informed consent is obtained from the patient by one of the co-investigator.
Adjuvants to local anesthetics are commonly added to prolong the duration of the peripheral nerve block. Sometimes patients have other added comorbidities along with high BMI with history of chronic pain where prolonging the duration of the peripheral nerve block would help with decreased narcotic consumption in the perioperative period with minimal side effects related to the local anesthetics(LA) as well as the adjuncts.
Dexmedetomidine is proven to be better than Clonidine in a recent study. Also perineural dexmedetomidine is proven to be more efficacious compared to intravenous dosing. The investigators are evaluating whether adding dexmedetomidine to standard dose of Ropivacaine helps in prolonging the duration of the peripheral nerve block with minimal side effects.
- Conditions
- Analgesia, Pain, Acute, Peripheral Nerve Block
- Being tested
- Dexmedetomidine, ropivacaine
- Keywords
- upper extremity bone fracture
- Medical subject headings
- Agnosia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
Addition of Dexmedetomidine in block .25mcg/kg of dexmedetomidine
ropivacaineDrug
Also called naropin
Standard of care 0.5%ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine only | Active comparator | 0.5% ropivacaine Receives: Drug: ropivacaine |
| ropivacaine with dexmedetomidine | Active comparator | 25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine Receives: Drug: Dexmedetomidine; Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Effect
To determine the change in duration of analgesia by the time to first intake of analgesic medicine by adding 0.25mcg/kg of dexmedetomidine to 25 ml of 0.5%ropivacaine in Brachial plexus nerve block.
Measured: Immediate pre-op until 36hours post block
Secondary outcomes (1)
Potential Side Effects
To look for the potential side effects of dexmedetomidine like bradycardia and hypotension in the intraoperative and immediate post-operative period.
Measured: Immediate pre-op until 36hours post block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study startApr 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: PI is leaving the University of Florida
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Model description
- This is a prospective, randomized, double blind study of adding dexmedetomidine 0.25mcg/kg body weight to standard dose (25ml) of 0.5%ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales (0-10), Satisfaction scale by VAS scale (0-10) and time to first analgesic consumption.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Ardon, MD, Principal investigator, University of Florida College of Medicine Jacksonville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385967
- Sponsor's protocol ID
- IRB201702926
- Status last verified
- May 2019
- First submitted
- 20 Dec 2017
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Double Blind Clinical Trial to Investigate the Increase in Duration of Analgesia With Addition of 0.25mcg/kg of Dexmedetomidine (DEX) to 25 ml of 0.5%Ropivacaine in Supraclavicular Brachial Plexus Block.
- ClinicalTrials.gov ID
- NCT03385967
- Acronym / sponsor ID
- IRB201702926
- Conditions
- Analgesia, Pain, Acute, Peripheral Nerve Block
- Keywords
- upper extremity bone fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is leaving the University of Florida
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Dec 2017 (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.
This is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10), Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. This study mainly aims to investigate whether addition of dexmedetomidine helps in increasing the duration of analgesia.
Detailed description
In our institute ropivacaine is used for all the peripheral nerve blocks. This a prospective, randomized, double blind clinical trial study comparing the addition of dexmedetomidine vs ropivacaine alone in brachial plexus nerve block. After screening the patient with the inclusion criteria, an informed consent is obtained from the patient by one of the co-investigator.
Adjuvants to local anesthetics are commonly added to prolong the duration of the peripheral nerve block. Sometimes patients have other added comorbidities along with high BMI with history of chronic pain where prolonging the duration of the peripheral nerve block would help with decreased narcotic consumption in the perioperative period with minimal side effects related to the local anesthetics(LA) as well as the adjuncts.
Dexmedetomidine is proven to be better than Clonidine in a recent study. Also perineural dexmedetomidine is proven to be more efficacious compared to intravenous dosing. The investigators are evaluating whether adding dexmedetomidine to standard dose of Ropivacaine helps in prolonging the duration of the peripheral nerve block with minimal side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, double blind study of adding dexmedetomidine 0.25mcg/kg body weight to standard dose (25ml) of 0.5%ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales (0-10), Satisfaction scale by VAS scale (0-10) and time to first analgesic consumption.
| Arm | Type | Receives |
|---|---|---|
| ropivacaine only | Active comparator | Drug: ropivacaine0.5% ropivacaine |
| ropivacaine with dexmedetomidine | Active comparator | Drug: Dexmedetomidine, Drug: ropivacaine25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age-18years and above
- Both male and female patients
- BMI->18
- Elective Subacute upper extremity fractures
Key exclusion criteria (4 listed)
- Chronic pain patients (Pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.)
- Patients with drug abuse history in the past 6 months
- ESRD
- Hepatic failure
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: precedexAddition of Dexmedetomidine in block .25mcg/kg of dexmedetomidine | Drug | ropivacaine with dexmedetomidine |
| ropivacaineAlso: naropinStandard of care 0.5%ropivacaine | Drug | ropivacaine only, ropivacaine with dexmedetomidine |
Primary outcome
Duration of Effect
Time frame: Immediate pre-op until 36hours post block
To determine the change in duration of analgesia by the time to first intake of analgesic medicine by adding 0.25mcg/kg of dexmedetomidine to 25 ml of 0.5%ropivacaine in Brachial plexus nerve block.
1 secondary outcome
Potential Side Effects
Time frame: Immediate pre-op until 36hours post block
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- 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.
Alberto Ardon, MD principal investigator
University of Florida College of Medicine Jacksonville
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and ropivacaine in people with Analgesia and Pain, Acute, run by University of Florida.
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: withdrawn, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Effect (time frame: Immediate pre-op until 36hours post block). 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 23 May 2019.