Osteoarthritis: ShoulderNCT02695758
Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing TSA
A study testing Interscalene brachial plexus block and bupivacaine extended-release liposome injection in people with Osteoarthritis: Shoulder, run by Rothman Institute Orthopaedics.
Trial summary
A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis: Shoulder
- What is being tested?
- Interscalene brachial plexus block and bupivacaine extended-release liposome injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 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
- 1. All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Methodist Hospital or Rothman Specialty Hospital.
Who cannot join
- Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
- Revision arthroplasty, arthroplasty for fracture
- Unable/unwilling to consent for enrollment
- Unable to complete postoperative pain survey
- Known adverse drug reaction or allergy to the medications used
- Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
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- Patients taking long acting narcotic pain medications (including extended release narcotic pain medications and methadone).
- Patients under the age of 18 years
- Patients with history of hepatic disease
- Pregnant women or women who are breastfeeding
About this study
Official title: Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing Shoulder Arthroplasty (TSA): A Randomized Trial
A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups.
- Conditions
- Osteoarthritis: Shoulder
- Being tested
- Interscalene brachial plexus block, bupivacaine extended-release liposome injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
bupivacaine extended-release liposome injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| interscalene brachial plexus block | Active comparator | Direct interscalene nerve block injection via brachial plexus Receives: Procedure: Interscalene brachial plexus block |
| Bupivacaine extended-release liposome injection | Active comparator | Infiltration of local anesthetic/analgesic, Bupivacaine extended-release liposome injection (Exparel) + Diluted in 40cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues. Receives: Procedure: bupivacaine extended-release liposome injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine and Morphine Equivalent consumption
Measured: 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis: ShoulderStudies 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
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695758
- Sponsor's protocol ID
- 2016Nam2
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing Shoulder Arthroplasty (TSA): A Randomized Trial
- ClinicalTrials.gov ID
- NCT02695758
- Acronym / sponsor ID
- 2016Nam2
- Conditions
- Osteoarthritis: Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- First posted
- 1 Mar 2016 (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.
A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interscalene brachial plexus block | Active comparator | Procedure: Interscalene brachial plexus blockDirect interscalene nerve block injection via brachial plexus |
| Bupivacaine extended-release liposome injection | Active comparator | Procedure: bupivacaine extended-release liposome injectionInfiltration of local anesthetic/analgesic, Bupivacaine extended-release liposome injection (Exparel) + Diluted in 40cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Methodist Hospital or Rothman Specialty Hospital.
Key exclusion criteria (10 listed)
- Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
- Revision arthroplasty, arthroplasty for fracture
- Unable/unwilling to consent for enrollment
- Unable to complete postoperative pain survey
- Known adverse drug reaction or allergy to the medications used
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 |
|---|---|---|
| Interscalene brachial plexus block | Procedure or surgery | interscalene brachial plexus block |
| bupivacaine extended-release liposome injection | Procedure or surgery | Bupivacaine extended-release liposome injection |
Primary outcome
Morphine and Morphine Equivalent consumption
Time frame: 24 hours following 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 1 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene brachial plexus block and bupivacaine extended-release liposome injection in people with Osteoarthritis: Shoulder, run by Rothman Institute Orthopaedics.
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 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Morphine and Morphine Equivalent consumption (time frame: 24 hours following 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 1 Mar 2016.