Pain, PostoperativeNCT02287142
Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery
A study testing Brachial plexus nerve block in people with Pain, Postoperative and Pain, run by Benaroya Research Institute at 1 site in United States.
Trial summary
The aim of this study is to assess analgesic efficacy of a supraclavicular nerve block, suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder arthroscopy with rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Pain, Shoulder Joint
- What is being tested?
- Brachial plexus nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2016
- 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
- Unilateral total shoulder arthroscopy for rotator cuff surgery ASA physical status I-III, >18 years old, Non-pregnant, Consent to participate in the study
Who cannot join
- Refusal to participate, < 18 years old, Chronic opioid use, Localized infection, Pregnancy or lactating, Pre-existing coagulopathy, Allergy to ultrasound gel or local anesthetics, Diaphragmatic dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98104
About this study
The aim of this study is to assess analgesic efficacy of a supraclavicular nerve block, suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all three arms will receive equal analgesia since these blocks are routinely performed to treat post-operative pain after shoulder surgery.
- Conditions
- Pain, Postoperative, Pain, Shoulder Joint, Pathologic Processes
- Being tested
- Brachial plexus nerve block
- Medical subject headings
- Pain, Postoperative, Pain, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial plexus nerve blockProcedure or surgery
All arms of the study comparing the three different blocks are receiving the same single injection bolus of ropivacaine 0.5% prior to surgery. We will then record and compare pain scores in PACU and opioid requirement.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene | Active comparator | Single-shot Interscalene Nerve Block with ropivacaine 0.5% Receives: Procedure: Brachial plexus nerve block |
| Supraclavicular | Active comparator | Single-shot Supraclavicular Nerve Block with ropivacaine 0.5% Receives: Procedure: Brachial plexus nerve block |
| Suprascapular | Active comparator | Single-shot Suprascapular Nerve Block with ropivacaine 0.5% Receives: Procedure: Brachial plexus nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
NRS Pain Scale
Measured: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Secondary outcomes (3)
Lung function
Vital Capacity, Spirometry
Measured: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Sensory and Motor Function
Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynamometer
Measured: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Diaphragmatic excursion
Ultrasound measuring the diaphragm movement in centimeters (cm)
Measured: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Auyong, Benaroya Research Institute
- Investigators
- David Auyong, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287142
- Sponsor's protocol ID
- IRB 14013
- Status last verified
- Jan 2017
- First submitted
- 5 Nov 2014
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery
- ClinicalTrials.gov ID
- NCT02287142
- Acronym / sponsor ID
- IRB 14013
- Conditions
- Pain, Postoperative, Pain, Shoulder Joint, Pathologic Processes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Nov 2014 (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 assess analgesic efficacy of a supraclavicular nerve block, suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all three arms will receive equal analgesia since these blocks are routinely performed to treat post-operative pain after shoulder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interscalene | Active comparator | Procedure: Brachial plexus nerve blockSingle-shot Interscalene Nerve Block with ropivacaine 0.5% |
| Supraclavicular | Active comparator | Procedure: Brachial plexus nerve blockSingle-shot Supraclavicular Nerve Block with ropivacaine 0.5% |
| Suprascapular | Active comparator | Procedure: Brachial plexus nerve blockSingle-shot Suprascapular Nerve Block with ropivacaine 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral total shoulder arthroscopy for rotator cuff surgery ASA physical status I-III, >18 years old, Non-pregnant, Consent to participate in the study
Key exclusion criteria (1 listed)
- Refusal to participate, < 18 years old, Chronic opioid use, Localized infection, Pregnancy or lactating, Pre-existing coagulopathy, Allergy to ultrasound gel or local anesthetics, Diaphragmatic dysfunction
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 |
|---|---|---|
| Brachial plexus nerve blockAll arms of the study comparing the three different blocks are receiving the same single injection bolus of ropivacaine 0.5% prior to surgery. We will then record and compare pain scores in PACU and opioid requirement. | Procedure or surgery | Interscalene, Supraclavicular, Suprascapular |
Primary outcome
Pain
Time frame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
NRS Pain Scale
3 secondary outcomes
Lung function
Time frame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Sensory and Motor Function
Time frame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Diaphragmatic excursion
Time frame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
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 2 Feb 2017.
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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 Auyong, MD principal investigator
Virginia Mason Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachial plexus nerve block in people with Pain, Postoperative and Pain, run by Benaroya Research Institute 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 1 inclusion and 1 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 2 Feb 2017. 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?
Pain (time frame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery). 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 2 Feb 2017.