Post-Operative PainNCT02117778
Comparison of Pulmonary Function and Efficacy of Different Nerve Block Catheters for Shoulder Surgery
A study testing Continuous Nerve Block in people with Post-Operative Pain, run by Benaroya Research Institute at 1 site in United States.
Trial summary
This study is designed to evaluate lung function and pain control of continuous supraclavicular versus suprascapular versus interscalene nerve catheters in subjects undergoing total shoulder replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Pain
- What is being tested?
- Continuous Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jan 2015
- 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 arthroplasty
- ASA physical status I-III
- >18 years old
- Non-pregnant (or lactating)
- 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, 98101
About this study
Official title: A Comparative Pulmonary Function Study of Continuous Supraclavicular, Suprascapular, and Interscalene Nerve Catheters After Total Shoulder Arthroplasty
This study is designed to evaluate lung function and pain control of continuous supraclavicular versus suprascapular versus interscalene nerve catheters in subjects undergoing total shoulder replacement. The investigators hypothesize that all three groups would have similar pain control; the supraclavicular and suprascapular groups may have better lung function.
- Conditions
- Post-Operative Pain
- Being tested
- Continuous Nerve Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Nerve BlockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Interscalene | Active comparator | Continuous Interscalene Nerve Block Receives: Procedure: Continuous Nerve Block |
| Supraclavicular | Active comparator | Continuous Supraclavicular Nerve Block Receives: Procedure: Continuous Nerve Block |
| Suprascapular | Active comparator | Continuous Suprascapular Nerve Block Receives: Procedure: Continuous Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Vital Capacity, Spirometry
Measured: Post-Operative Day 1
Secondary outcomes (3)
Pain
NRS Pain Scale
Measured: Post Operative Day 1
Opioid Consumption
Total opioid consumption x 24 hours
Measured: Post Operative Day 1
Sensory and Motor Function
Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynometer
Measured: Post Operative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative PainStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Auyong, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117778
- Sponsor's protocol ID
- BRI IRB13086
- Status last verified
- Feb 2017
- First submitted
- 24 Jan 2014
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Pulmonary Function Study of Continuous Supraclavicular, Suprascapular, and Interscalene Nerve Catheters After Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT02117778
- Acronym / sponsor ID
- BRI IRB13086
- Conditions
- Post-Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Apr 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.
This study is designed to evaluate lung function and pain control of continuous supraclavicular versus suprascapular versus interscalene nerve catheters in subjects undergoing total shoulder replacement. The investigators hypothesize that all three groups would have similar pain control; the supraclavicular and suprascapular groups may have better lung function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interscalene | Active comparator | Procedure: Continuous Nerve BlockContinuous Interscalene Nerve Block |
| Supraclavicular | Active comparator | Procedure: Continuous Nerve BlockContinuous Supraclavicular Nerve Block |
| Suprascapular | Active comparator | Procedure: Continuous Nerve BlockContinuous Suprascapular Nerve Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral total shoulder arthroplasty
- ASA physical status I-III
- >18 years old
- Non-pregnant (or lactating)
- Consent to participate in the study
Key exclusion criteria (8 listed)
- Refusal to participate
- < 18 years old
- Chronic opioid use
- Localized infection
- Pregnancy or lactating
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 |
|---|---|---|
| Continuous Nerve Block | Procedure or surgery | Interscalene, Supraclavicular, Suprascapular |
Primary outcome
Lung function
Time frame: Post-Operative Day 1
Vital Capacity, Spirometry
3 secondary outcomes
Pain
Time frame: Post Operative Day 1
Opioid Consumption
Time frame: Post Operative Day 1
Sensory and Motor Function
Time frame: Post Operative Day 1
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 3 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
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Nerve Block in people with Post-Operative 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 5 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 3 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?
Lung function (time frame: Post-Operative Day 1). 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 3 Feb 2017.