Upper Extremity ProblemPhase 4SUPRANCT03957772
The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block
A Phase 4 study testing Extrafascial injection and Intrafascial injection in people with Upper Extremity Problem, run by Hôpital du Valais at 1 site in Switzerland.
Trial summary
Patients will be randomized to one of two groups: 1. Extrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the exterior of the fascial sheath that surrounds the nerves 2. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Upper Extremity Problem
- What is being tested?
- Extrafascial injection and Intrafascial injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2020to 30 Apr 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing forearm or hand surgery under locoregional anesthesia
- ASA physical status I-III
Who cannot join
- Patient refusal
- ASA physical status IV
- Severe pre-existing lung disease
- Patient unwilling or unable to perform incentive spirometry
- Local anesthetic intolerance or allergy
- Neurological deficit or neuropathy of the arm
Show all 10Show fewer
- Coagulopathy contraindicating locoregional anesthesia
- Malignancy or infection in the area above the clavicle
- Pregnancy
- Inability to understand the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block: a Randomized Controlled, Single-blinded Trial
Patients will be randomized to one of two groups:
- Extrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the exterior of the fascial sheath that surrounds the nerves
- Intrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the interior of the fascial sheath that surrounds the nerves
Read the detailed description
The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups.
The first group - extrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the exterior of the fascial sheath that surrounds the nerves.
The second group - intrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the interior of the fascial sheath that surrounds the nerves.
All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.
The primary outcome is the rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound. Secondary outcomes are: rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound, bedside spirometry before the supraclavicular block, 30 minutes after the block and 2 hours after surgery, rate of successful block 30 minutes after the block , duration of sensory and motor block, pain scores at rest and on movement at 24 h postoperatively, cumulative postoperative opioid consumption at 24 hours postoperatively and patient satisfaction with overall anesthetic management.
These outcomes are further defined in the section below.
- Conditions
- Upper Extremity Problem
- Being tested
- Extrafascial injection, Intrafascial injection
- Keywords
- upper extremity surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extrafascial injectionProcedure or surgery
Extrafascial injection of local anaesthetic under ultrasound guidance
Intrafascial injectionProcedure or surgery
Intrafascial injection of local anaesthetic under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Extrafascial injection | Active comparator | Extrafascial injection of local anesthetic
Ultrasound guided supraclavicular plexus block with extrafascial injection of local anesthetic Receives: Procedure: Extrafascial injection |
| Intrafascial injection | Experimental | Intrafascial injection of local anesthetic
Ultrasound guided supraclavicular plexus block with intrafascial injection of local anesthetic Receives: Procedure: Intrafascial injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemidiaphragmatic paresis 30 minutes after the block
Rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound
Measured: 30 minutes after the block
Secondary outcomes (10)
Hemidiaphragmatic paresis 2 hours after surgery
Rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound
Measured: 2 hours after surgery
Bedside spirometry before the block (baseline)
Bedside spirometry before the supraclavicular block
Measured: 30 minutes before the block
Bedside spirometry after 30 minutes after the block
Bedside spirometry after the supraclavicular block
Measured: 30 minutes after the supraclavicular block
Bedside spirometry 2 hours after surgery
Bedside spirometry 2 hours after surgery
Measured: 2 hours after surgery
Rate of successful block 30 minutes after the block
Presence of a surgical block according to a validated composite scale
Measured: 30 minutes after the block
Block-related side effects
paresthesia, dyspnea, Horner's syndrome, hoarseness, hematoma, infection
Measured: 24 h postoperatively
Pain during block procedure
Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain)
Measured: During block procedure
Pain at rest and on movement
Pain score (numeric rating scale, 0-10, with 0=no pain, 10=worst imaginable pain)
Measured: 24 h postoperatively
Postoperative opioid consumption
Cumulative postoperative opioid consumption
Measured: 24 hours postoperatively
Patient satisfaction with overall anesthetic management
numeric rating scale, 0-10)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Jan 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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 Upper Extremity ProblemStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Sina Grape, MD, Principal investigator, Hôpital du Valais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957772
- Sponsor's protocol ID
- 2019 SUPRA
- Acronym
- SUPRA
- Status last verified
- May 2021
- First submitted
- 17 May 2019
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing of any IPD
Publications
Grape S, Kirkham K, Zemirline N, Bikfalvi A, Albrecht E. Impact of an extrafascial versus intrafascial injection for supraclavicular brachial plexus block on respiratory function: a randomized, controlled, double-blind trial. Reg Anesth Pain Med. 2022 Oct;47(10):604-609. doi: 10.1136/rapm-2022-103634. Epub 2022 Jul 1.
PubMed 35777931
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block: a Randomized Controlled, Single-blinded Trial
- ClinicalTrials.gov ID
- NCT03957772
- Acronym / sponsor ID
- SUPRA / 2019 SUPRA
- Conditions
- Upper Extremity Problem
- Keywords
- upper extremity surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 21 May 2019 (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.
Patients will be randomized to one of two groups:
- Extrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the exterior of the fascial sheath that surrounds the nerves
- Intrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the interior of the fascial sheath that surrounds the nerves
Detailed description
The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups.
The first group - extrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the exterior of the fascial sheath that surrounds the nerves.
The second group - intrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the interior of the fascial sheath that surrounds the nerves.
All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.
The primary outcome is the rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound. Secondary outcomes are: rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound, bedside spirometry before the supraclavicular block, 30 minutes after the block and 2 hours after surgery, rate of successful block 30 minutes after the block , duration of sensory and motor block, pain scores at rest and on movement at 24 h postoperatively, cumulative postoperative opioid consumption at 24 hours postoperatively and patient satisfaction with overall anesthetic management.
These outcomes are further defined in the section below.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Extrafascial injection | Active comparator | Procedure: Extrafascial injectionExtrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with extrafascial injection of local anesthetic |
| Intrafascial injection | Experimental | Procedure: Intrafascial injectionIntrafascial injection of local anesthetic Ultrasound guided supraclavicular plexus block with intrafascial injection of local anesthetic |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing forearm or hand surgery under locoregional anesthesia
- ASA physical status I-III
Key exclusion criteria (10 listed)
- Patient refusal
- ASA physical status IV
- Severe pre-existing lung disease
- Patient unwilling or unable to perform incentive spirometry
- Local anesthetic intolerance or allergy
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 |
|---|---|---|
| Extrafascial injectionExtrafascial injection of local anaesthetic under ultrasound guidance | Procedure or surgery | Extrafascial injection |
| Intrafascial injectionIntrafascial injection of local anaesthetic under ultrasound guidance | Procedure or surgery | Intrafascial injection |
Primary outcome
Hemidiaphragmatic paresis 30 minutes after the block
Time frame: 30 minutes after the block
Rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound
10 secondary outcomes
Hemidiaphragmatic paresis 2 hours after surgery
Time frame: 2 hours after surgery
Bedside spirometry before the block (baseline)
Time frame: 30 minutes before the block
Bedside spirometry after 30 minutes after the block
Time frame: 30 minutes after the supraclavicular block
Bedside spirometry 2 hours after surgery
Time frame: 2 hours after surgery
Rate of successful block 30 minutes after the block
Time frame: 30 minutes after the block
Block-related side effects
Time frame: 24 h postoperatively
Pain during block procedure
Time frame: During block procedure
Pain at rest and on movement
Time frame: 24 h postoperatively
Postoperative opioid consumption
Time frame: 24 hours postoperatively
Patient satisfaction with overall anesthetic management
Time frame: 24 hours postoperatively
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 18 May 2021.
- Derived from this study: PubMed 35777931Grape S, Kirkham K, Zemirline N, Bikfalvi A, Albrecht E. Impact of an extrafascial versus intrafascial injection for supraclavicular brachial plexus block on respiratory function: a randomized, controlled, double-blind trial. Reg Anesth Pain Med. 2022 Oct;47(10):604-609. doi: 10.1136/rapm-2022-103634. Epub 2022 Jul 1.
- Individual participant dataSharing planned: No. no sharing of any IPD
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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.
Sina Grape, MD principal investigator
Hôpital du Valais
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 Extrafascial injection and Intrafascial injection in people with Upper Extremity Problem, run by Hôpital du Valais at 1 site in Switzerland.
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 2 inclusion and 10 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 18 May 2021. 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 Switzerland. 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?
Hemidiaphragmatic paresis 30 minutes after the block (time frame: 30 minutes after the block). 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 NCT03957772, 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 18 May 2021.