Phrenic Nerve ParalysisNCT02631122
Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis
A study testing Supraclavicular vs Retroclavicular Nerve Block in people with Phrenic Nerve Paralysis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks: two similar brachial plexus nerve block techniques that differ in their needle trajectory and injection site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phrenic Nerve Paralysis
- What is being tested?
- Supraclavicular vs Retroclavicular Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2017to 21 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for lower arm surgery
- patients aged 18 years or older
- patients ASA class I-III
Who cannot join
- Patients unable to cooperate or consent to the study
- pre-existing neuropathy
- significant pulmonary disease
- contralateral phrenic nerve or diaphragmatic dysfunction
- allergy to local anesthetics
- infection at needle insertion site
- history of coagulopathy
- BMI > 40 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Supraclavicular Brachial Plexus Block vs Retroclavicular Brachial Plexus Block: Comparison of Impact on Ipsilateral Diaphragmatic Function
The aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks: two similar brachial plexus nerve block techniques that differ in their needle trajectory and injection site.
Read the detailed description
To date, there has not been a study that has compared clinically the retroclavicular brachial plexus block to the supraclavicular brachial plexus block or other brachial plexus blocks. The aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks, with primary focus on the incidence of diminished ipsilateral hemidiaphramatic excursion (ipsilateral phrenic nerve blockade). We will also evaluate differences between the two techniques in the success of producing surgical anesthesia, procedural time to perform the block (including imaging time and needling time), block onset time, ease of quality ultrasound needle visualization, and incidence of paresthesias, vascular puncture and pneumothorax. Lastly, we will observe and compare the distribution of motor and sensory blockade of the two techniques
- Conditions
- Phrenic Nerve Paralysis
- Being tested
- Supraclavicular vs Retroclavicular Nerve Block
- Keywords
- Retroclavicular, Supraclavicular, Diagphram, hemiparesis, nerve block, regional anesthesia, anesthesiology
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular vs Retroclavicular Nerve BlockProcedure or surgery
An ultrasound-guided supraclavicular or retroclavicular nerve block with 30 ml of 0.5% ropivicaine will be performed on patients scheduled for lower arm surgery; 25 ml to be delivered to the brachial plexus and 5 ml to the intercostal nerve
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular BPNB | Active comparator | Patients in this group will be randomized to receive an Ultrasound Guided Supraclavicular Brachial Plexus Nerve Block and outcomes will be measured over the perioperative and 1day time period. Receives: Procedure: Supraclavicular vs Retroclavicular Nerve Block |
| Retroclavicular BNPB | Active comparator | Patients in this group will be randomized to receive an Ultrasound Guided Retroclavicular Brachial Plexus Nerve Block and outcomes will be measured over the perioperative and 1day time period. Receives: Procedure: Supraclavicular vs Retroclavicular Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IIpsilateral Diaphragmatic Paresis
As evidence by ipsilater diagphragmatic excursion measured by Mmode ultrasound
Measured: 30 minutes post block, then postoperatively
Secondary outcomes (4)
Anesthetic and analgesic efficacy
Block success will be defined as onset of acceptable sensory and motor blockade
Measured: 30 minutes post block, then postoperatively
Procedural times (imaging time and needling time), onset time, ease of placement, and block duration
Ultrasonographic block imaging times (time between ultrasound probe placement on the patient and satisfactory image of target anatomy acquisition. needling time (time between needle insertion into the skin and the end of local anesthetic injection through the block needle), onset and duration of sensory block, and proceduralist's rating of ease of block performance will be measured.
Measured: at the time of block
Complication rates
Rates of vascular puncture, pneumothorax and paresthesias will be recorded
Measured: 1 day
Nerve block distribution
measured through sensation (cold and pin prick) over dermatomes of the brachial plexus
Measured: 30 minutes post block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start7 Dec 2017
- Primary completion20 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phrenic Nerve ParalysisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamen Vlassakov, Brigham and Women's Hospital
- Investigators
- Kamen Vlassakov, MD, Principal investigator, kvlassakov@partners.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631122
- Sponsor's protocol ID
- 2015P001537
- Status last verified
- Oct 2019
- First submitted
- 4 Dec 2015
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Georgiadis PL, Vlassakov KV, Patton ME, Lirk PB, Janfaza DR, Zeballos JL, Quaye AN, Patel V, Schreiber KL. Ultrasound-guided supraclavicular vs. retroclavicular block of the brachial plexus: comparison of ipsilateral diaphragmatic function: A randomised clinical trial. Eur J Anaesthesiol. 2021 Jan;38(1):64-72. doi: 10.1097/EJA.0000000000001305.
PubMed 32925256
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Supraclavicular Brachial Plexus Block vs Retroclavicular Brachial Plexus Block: Comparison of Impact on Ipsilateral Diaphragmatic Function
- ClinicalTrials.gov ID
- NCT02631122
- Acronym / sponsor ID
- 2015P001537
- Conditions
- Phrenic Nerve Paralysis
- Keywords
- Retroclavicular, Supraclavicular, Diagphram, hemiparesis, nerve block, regional anesthesia, anesthesiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 16 Dec 2015 (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 is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks: two similar brachial plexus nerve block techniques that differ in their needle trajectory and injection site.
Detailed description
To date, there has not been a study that has compared clinically the retroclavicular brachial plexus block to the supraclavicular brachial plexus block or other brachial plexus blocks. The aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks, with primary focus on the incidence of diminished ipsilateral hemidiaphramatic excursion (ipsilateral phrenic nerve blockade). We will also evaluate differences between the two techniques in the success of producing surgical anesthesia, procedural time to perform the block (including imaging time and needling time), block onset time, ease of quality ultrasound needle visualization, and incidence of paresthesias, vascular puncture and pneumothorax. Lastly, we will observe and compare the distribution of motor and sensory blockade of the two techniques
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular BPNB | Active comparator | Procedure: Supraclavicular vs Retroclavicular Nerve BlockPatients in this group will be randomized to receive an Ultrasound Guided Supraclavicular Brachial Plexus Nerve Block and outcomes will be measured over the perioperative and 1day time period. |
| Retroclavicular BNPB | Active comparator | Procedure: Supraclavicular vs Retroclavicular Nerve BlockPatients in this group will be randomized to receive an Ultrasound Guided Retroclavicular Brachial Plexus Nerve Block and outcomes will be measured over the perioperative and 1day time period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients scheduled for lower arm surgery
- patients aged 18 years or older
- patients ASA class I-III
Key exclusion criteria (8 listed)
- Patients unable to cooperate or consent to the study
- pre-existing neuropathy
- significant pulmonary disease
- contralateral phrenic nerve or diaphragmatic dysfunction
- allergy to local anesthetics
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 |
|---|---|---|
| Supraclavicular vs Retroclavicular Nerve BlockAn ultrasound-guided supraclavicular or retroclavicular nerve block with 30 ml of 0.5% ropivicaine will be performed on patients scheduled for lower arm surgery; 25 ml to be delivered to the brachial plexus and 5 ml to the intercostal nerve | Procedure or surgery | Retroclavicular BNPB, Supraclavicular BPNB |
Primary outcome
Incidence of IIpsilateral Diaphragmatic Paresis
Time frame: 30 minutes post block, then postoperatively
As evidence by ipsilater diagphragmatic excursion measured by Mmode ultrasound
4 secondary outcomes
Anesthetic and analgesic efficacy
Time frame: 30 minutes post block, then postoperatively
Procedural times (imaging time and needling time), onset time, ease of placement, and block duration
Time frame: at the time of block
Complication rates
Time frame: 1 day
Nerve block distribution
Time frame: 30 minutes post block
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 22 Oct 2019.
- Derived from this study: PubMed 32925256Georgiadis PL, Vlassakov KV, Patton ME, Lirk PB, Janfaza DR, Zeballos JL, Quaye AN, Patel V, Schreiber KL. Ultrasound-guided supraclavicular vs. retroclavicular block of the brachial plexus: comparison of ipsilateral diaphragmatic function: A randomised clinical trial. Eur J Anaesthesiol. 2021 Jan;38(1):64-72. doi: 10.1097/EJA.0000000000001305.
- 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.
Kamen Vlassakov, MD principal investigator
kvlassakov@partners.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraclavicular vs Retroclavicular Nerve Block in people with Phrenic Nerve Paralysis, run by Brigham and Women's Hospital at 1 site 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 3 inclusion and 8 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 22 Oct 2019. 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 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?
Incidence of IIpsilateral Diaphragmatic Paresis (time frame: 30 minutes post block, then postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631122, which also lists 1 linked publication.
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 22 Oct 2019.