ArthrosesNCT02769429
Continuous Blockade of the Brachial Plexus
An observational study of Arthroses and Degenerative Disorder, run by University of Florida at 2 sites in United States.
Trial summary
This study will answer the question whether there is a difference in the effects and complication rates of ultrasound guided continuous interscalene block (CISB) and nerve stimulation-guided continuous cervical paravertebral block (CCPVB). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroses, Degenerative Disorder, Osteoarthritis
- What is being tested?
- Ultrasound-guided CISB and nerve stimulator-guided CCPVB
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2016to 26 Sep 2018
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are are scheduled for shoulder arthroplasty or rotator cuff repair surgery at an area hospital
Who may be able to join
- The general inclusion will be those adult patients who:
- are between the ages of 18 and 80 years
- have an ASA Health Classification of I, II, or III
- are scheduled for shoulder arthroplasty or rotator cuff repair surgery
- Patients with a BMI of =to/< 40 Exclusion
- The Exclusion criteria will include:
Show all 10Show fewer
- Patient refusal to participate in the study or sign informed consent
- Patients with contraindications to any of the two blocks or allergy to any of the drugs used
- Patients with shoulder surgery that developed into any other surgery other than total shoulder arthroplasty or rotator cuff repair
- Patients with a BMI >40
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida Surgical Center
Gainesville, Florida, 32607
UF Health
Gainesville, Florida, 32610-3003
About this study
Official title: Is There a Difference Between Posterior Approach Ultrasound-guided Continuous Interscalene Block (Upper Trunk Block) and Stimulator Guided Continuous Cervical Paravertebral Block (C6 Root Block)?
This study will answer the question whether there is a difference in the effects and complication rates of ultrasound guided continuous interscalene block (CISB) and nerve stimulation-guided continuous cervical paravertebral block (CCPVB). The aim of this study is to evaluate the differences in efficacy and side effects - if any.
Read the detailed description
This is a prospective randomized double-blinded study that will compare two commonly used approaches for the continuous blockade of the brachial plexus: the CCPVB, which focusses on the six cervical nerve root (C6 root), and CISB, which focuses on the upper trunk of the brachial plexus. Data of sensory testing, motor strength, shoulder pain, phrenic nerve function, recurrent laryngeal nerve (RNL) function, ipsilateral Horner's syndrome, block time and medication doses used for block placement, will be collected. All observations and measurements will be made by a member of the research team who is unaware of patient allocation to any particular group.
- Conditions
- Arthroses, Degenerative Disorder, Osteoarthritis
- Being tested
- Ultrasound-guided CISB, nerve stimulator-guided CCPVB
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided CISBDevice
This group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus
nerve stimulator-guided CCPVBDevice
This group will receive landmark with nerve stimulator based needle placement and then nerve stimulator-guided CCPVB with the catheter placed on the 6th cervical spinal root
| Study group | Role | What they receive |
|---|---|---|
| ultrasound-guided CISB | Group 1 will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus Receives: Device: Ultrasound-guided CISB | |
| nerve stimulator-guided CCPVB | Group 2 will receive landmark with nerve stimulator based needle placement and then nerve stimulator-guided CCPVB with the catheter placed on the 6th cervical spinal root Receives: Device: nerve stimulator-guided CCPVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes between the two groups assessed by sensory testing
Sensory abnormalities will be assessed by sensation of cold and dermatomes sensation.
Measured: Change from baseline up to 7 days (end of catheter placement)
Secondary outcomes (5)
Changes between the two groups assessed by motor strength
Motor strength will be assessed on a scale of 0 to 5 Medical Research Council (MRC) scale
Measured: Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by shoulder pain
Shoulder pain will be assessed by the Defense and Veterans Pain Rating Scale (DVPRS) where pain will be rated as no pain, mild, moderate, or severe pain, and on a scale of 0 to 10 where 0 represents no pain, 1 to 3 represents mild pain, 4 to 6 represents moderate pain, 7 to 9 represents severe pain, and 10 represents the worst pain imaginable where nothing else but the pain matters
Measured: Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by Phrenic nerve function
Phrenic nerve function will be evaluated by measuring the movements of the diaphragm by ultrasonography or the inability to visualize using ultrasound (US)
Measured: Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by recurrent laryngeal nerve (RLN) function
RLN function will be assessed by hoarseness or swallowing difficulty
Measured: Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by development of ipsilateral Horner's syndrome
Development of ipsilateral Horner's syndrome
Measured: Change from baseline up to 7 days (end of catheter placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start19 Sep 2016
- Primary completion6 Jun 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- I. Heermann Anesthesia Foundation
- Responsible party
- Sponsor
- Investigators
- Yury Zasimovich, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769429
- Sponsor's protocol ID
- IRB201600012
- Status last verified
- Jul 2019
- First submitted
- 9 May 2016
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Difference Between Posterior Approach Ultrasound-guided Continuous Interscalene Block (Upper Trunk Block) and Stimulator Guided Continuous Cervical Paravertebral Block (C6 Root Block)?
- ClinicalTrials.gov ID
- NCT02769429
- Acronym / sponsor ID
- IRB201600012
- Conditions
- Arthroses, Degenerative Disorder, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- I. Heermann Anesthesia Foundation
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 11 May 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.
This study will answer the question whether there is a difference in the effects and complication rates of ultrasound guided continuous interscalene block (CISB) and nerve stimulation-guided continuous cervical paravertebral block (CCPVB). The aim of this study is to evaluate the differences in efficacy and side effects - if any.
Detailed description
This is a prospective randomized double-blinded study that will compare two commonly used approaches for the continuous blockade of the brachial plexus: the CCPVB, which focusses on the six cervical nerve root (C6 root), and CISB, which focuses on the upper trunk of the brachial plexus. Data of sensory testing, motor strength, shoulder pain, phrenic nerve function, recurrent laryngeal nerve (RNL) function, ipsilateral Horner's syndrome, block time and medication doses used for block placement, will be collected. All observations and measurements will be made by a member of the research team who is unaware of patient allocation to any particular group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound-guided CISB | – | Device: Ultrasound-guided CISBGroup 1 will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus |
| nerve stimulator-guided CCPVB | – | Device: nerve stimulator-guided CCPVBGroup 2 will receive landmark with nerve stimulator based needle placement and then nerve stimulator-guided CCPVB with the catheter placed on the 6th cervical spinal root |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are are scheduled for shoulder arthroplasty or rotator cuff repair surgery at an area hospital
Key inclusion criteria (10 listed)
- The general inclusion will be those adult patients who:
- Patient refusal to participate in the study or sign informed consent
- Patients with contraindications to any of the two blocks or allergy to any of the drugs used
- Patients with shoulder surgery that developed into any other surgery other than total shoulder arthroplasty or rotator cuff repair
- Patients with a BMI >40
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ultrasound-guided CISBThis group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus | Device | ultrasound-guided CISB |
| nerve stimulator-guided CCPVBThis group will receive landmark with nerve stimulator based needle placement and then nerve stimulator-guided CCPVB with the catheter placed on the 6th cervical spinal root | Device | nerve stimulator-guided CCPVB |
Primary outcome
Changes between the two groups assessed by sensory testing
Time frame: Change from baseline up to 7 days (end of catheter placement)
Sensory abnormalities will be assessed by sensation of cold and dermatomes sensation.
5 secondary outcomes
Changes between the two groups assessed by motor strength
Time frame: Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by shoulder pain
Time frame: Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by Phrenic nerve function
Time frame: Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by recurrent laryngeal nerve (RLN) function
Time frame: Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by development of ipsilateral Horner's syndrome
Time frame: Change from baseline up to 7 days (end of catheter placement)
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 25 Jul 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.
Yury Zasimovich principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroses and Degenerative Disorder, run by University of Florida at 2 sites in United States.
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 10 inclusion and 0 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 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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?
Changes between the two groups assessed by sensory testing (time frame: Change from baseline up to 7 days (end of catheter placement)). 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 25 Jul 2019.