Joint DiseasePhase 4STBNCT03272139
Interscalene Block Versus Superior Trunk Block
A Phase 4 study testing Bupivacaine and Ultrasound in people with Joint Disease and Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Joint Disease, Pain, Pain, Acute
- What is being tested?
- Bupivacaine and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to 9 Jul 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients who will be undergoing primary unilateral labral repair/stabilization of the shoulder
- Age 18 to 80 years
- Planned use of general anesthesia with LMA and interscalene or superior trunk block
- Ability to follow study protocol
- English speaking
- ASA I - III
Who cannot join
- Pre-existing neuropathy of the operative limb
- Younger than 18 years old and older than 80
- Patients with pulmonary severe respiratory disease
- Allergy to one of the study medications
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (taking opioids for longer than 3 months)
Show all 9Show fewer
- Contraindication to general anesthesia, interscalene or superior trunk block
- Herniated Cervical Disk, Cervical Myelopathy
- BMI >35
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Interscalene Block Versus Superior Trunk Block: A Randomized Controlled Clinical Trial
Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair).
- Conditions
- Joint Disease, Pain, Pain, Acute, Pain, Chronic
- Being tested
- Bupivacaine, Ultrasound
- Medical subject headings
- Joint Diseases, Pain, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Anesthetic that will help treat pain and sensation after shoulder arthroscopy
UltrasoundDevice
Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
| Study group | Role | What they receive |
|---|---|---|
| interscalene block (ISB) | Experimental | The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected. Receives: Drug: Bupivacaine; Device: Ultrasound |
| superior trunk block (STB) | Experimental | The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk. Receives: Drug: Bupivacaine; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.
Measured: Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers
Numerical Pain Rating System (NRS) Pain Scores
Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System.
Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.
Measured: Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System
Secondary outcomes (1)
Block Duration
Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call
Measured: Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start28 Sep 2017
- Primary completion30 Dec 2018
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Joint DiseaseStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David H Kim, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272139
- Sponsor's protocol ID
- 2017-0979
- Acronym
- STB
- Status last verified
- Apr 2022
- First submitted
- 29 Aug 2017
- Last updated
- 11 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Block Versus Superior Trunk Block: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03272139
- Acronym / sponsor ID
- STB / 2017-0979
- Conditions
- Joint Disease, Pain, Pain, Acute, Pain, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair).
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 |
|---|---|---|
| interscalene block (ISB) | Experimental | Drug: Bupivacaine, Device: UltrasoundThe interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected. |
| superior trunk block (STB) | Experimental | Drug: Bupivacaine, Device: UltrasoundThe superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who will be undergoing primary unilateral labral repair/stabilization of the shoulder
- Age 18 to 80 years
- Planned use of general anesthesia with LMA and interscalene or superior trunk block
- Ability to follow study protocol
- English speaking
Key exclusion criteria (9 listed)
- Pre-existing neuropathy of the operative limb
- Younger than 18 years old and older than 80
- Patients with pulmonary severe respiratory disease
- Allergy to one of the study medications
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
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 |
|---|---|---|
| BupivacaineAnesthetic that will help treat pain and sensation after shoulder arthroscopy | Drug | interscalene block (ISB), superior trunk block (STB) |
| UltrasoundUltrasound will help guide the anesthesiologist in performing the different nerve blocks | Device | interscalene block (ISB), superior trunk block (STB) |
Primary outcome
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
Time frame: Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers
Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.
Numerical Pain Rating System (NRS) Pain Scores
Time frame: Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System
Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System. Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.
1 secondary outcome
Block Duration
Time frame: Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David H Kim, MD principal investigator
Hospital for Special Surgery, New York
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 Bupivacaine and Ultrasound in people with Joint Disease and Pain, run by Hospital for Special Surgery, New York 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 6 inclusion and 9 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 11 May 2022. 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.
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?
Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) (time frame: Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers). The study lists 2 primary outcomes in all. 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 11 May 2022.