AnesthesiaISBNCT06855381
Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus vs Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair
A study testing the ISBC group, SonoPlex needle and E-catheter and single bolus injection in people with Anesthesia, run by University of Foggia at 1 site in Italy.
Trial summary
Shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. Patients may experience severe postoperative (PO) pain, that can last for a month and can influence successful rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- the ISBC group, SonoPlex needle and E-catheter and single bolus injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- American Society of Anesthesia (ASA) physical status of 1 to 2,
- Body Mass Index (BMI) of less than 30 kg/m²,
- paitents undergoing shoulder arthroscopy for small to medium rotator cuff tears.
Who cannot join
- skin infection on the puncture site,
- coagulopathy
- brachial plexus neuropathy
- alcohol or drug abuse
- diabetes
- severe lung disease
- history of allergy to one or more study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus Injection Versus Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair-a Prospective Randomized Unblinded Trial
Shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. Patients may experience severe postoperative (PO) pain, that can last for a month and can influence successful rehabilitation. Our study aimes to evaluate the effectiveness of interscalene brachial plexus single-shot (ISBSS) versus continuous interscalene brachial plexus block (ISBC) in controlling perioperative pain and avoiding PO pain chronicization. This prospective randomized unblinded trial hypothesizes that the PO perineuronal infusion using a continuous ambulatory delivery device pump gives better pain control and outcomes than ISBSS during the long-term follow-up period.
Read the detailed description
Blocks will be performed under ultrasound guidance with 15 - 20 mL of 0.75 % ropivacaine.
- Conditions
- Anesthesia
- Being tested
- the ISBC group, SonoPlex needle and E-catheter, single bolus injection
- Keywords
- interscalene block, pain management, regional anesthesia, shoulder arthroscopy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the ISBC group, SonoPlex needle and E-catheterProcedure or surgery
in the ISBC group, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used. The E-catheter will be inserted into the indwelling cannula.
single bolus injectionProcedure or surgery
An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used
| Study group | Role | What they receive |
|---|---|---|
| effectiveness of interscalene brachial plexus single-shot | Active comparator | An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used Receives: Procedure: single bolus injection |
| continuous interscalene brachial plexus block | Experimental | An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this arm, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used. Receives: Procedure: the ISBC group, SonoPlex needle and E-catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Tha pain severity will be evaluated by NRS scale
Measured: 24 hour, 48 hour, 72 hour, 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Feb 2022
- Primary completion28 Feb 2024
- Study completion28 Feb 2025 (estimated)
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 AnesthesiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cotoia Antonella, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855381
- Sponsor's protocol ID
- unifg
- Acronym
- ISB
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uno T, Mura N, Yuki I, Oishi R, Takagi M. The effect of continuous interscalene brachial plexus block for arthroscopic rotator cuff repair. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2024 Feb 2;36:6-12. doi: 10.1016/j.asmart.2024.01.004. eCollection 2024 Apr.
PubMed 38344106
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus Injection Versus Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair-a Prospective Randomized Unblinded Trial
- ClinicalTrials.gov ID
- NCT06855381
- Acronym / sponsor ID
- ISB / unifg
- Conditions
- Anesthesia
- Keywords
- interscalene block, pain management, regional anesthesia, shoulder arthroscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 3 Mar 2025 (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.
Shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. Patients may experience severe postoperative (PO) pain, that can last for a month and can influence successful rehabilitation. Our study aimes to evaluate the effectiveness of interscalene brachial plexus single-shot (ISBSS) versus continuous interscalene brachial plexus block (ISBC) in controlling perioperative pain and avoiding PO pain chronicization. This prospective randomized unblinded trial hypothesizes that the PO perineuronal infusion using a continuous ambulatory delivery device pump gives better pain control and outcomes than ISBSS during the long-term follow-up period.
Detailed description
Blocks will be performed under ultrasound guidance with 15 - 20 mL of 0.75 % ropivacaine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| effectiveness of interscalene brachial plexus single-shot | Active comparator | Procedure: single bolus injectionAn ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used |
| continuous interscalene brachial plexus block | Experimental | Procedure: the ISBC group, SonoPlex needle and E-catheterAn ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this arm, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesia (ASA) physical status of 1 to 2,
- Body Mass Index (BMI) of less than 30 kg/m²,
- paitents undergoing shoulder arthroscopy for small to medium rotator cuff tears.
Key exclusion criteria (7 listed)
- skin infection on the puncture site,
- coagulopathy
- brachial plexus neuropathy
- alcohol or drug abuse
- diabetes
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 |
|---|---|---|
| the ISBC group, SonoPlex needle and E-catheterin the ISBC group, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used. The E-catheter will be inserted into the indwelling cannula. | Procedure or surgery | continuous interscalene brachial plexus block |
| single bolus injectionAn ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used | Procedure or surgery | effectiveness of interscalene brachial plexus single-shot |
Primary outcome
Pain severity
Time frame: 24 hour, 48 hour, 72 hour, 7 day
Tha pain severity will be evaluated by NRS scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Results publication: PubMed 38344106Uno T, Mura N, Yuki I, Oishi R, Takagi M. The effect of continuous interscalene brachial plexus block for arthroscopic rotator cuff repair. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2024 Feb 2;36:6-12. doi: 10.1016/j.asmart.2024.01.004. eCollection 2024 Apr.
- Related InfoLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the ISBC group, SonoPlex needle and E-catheter and single bolus injection in people with Anesthesia, run by University of Foggia at 1 site in Italy.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain severity (time frame: 24 hour, 48 hour, 72 hour, 7 day). 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 NCT06855381, 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 3 Mar 2025.