Rotator Cuff InjuryEarly Phase 1NCT01355757
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
A Early Phase 1 study testing Baxter INFUSOR System and Single Injection of Local Anesthetic in people with Rotator Cuff Injury, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- Baxter INFUSOR System and Single Injection of Local Anesthetic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jan 2013
- Phase
- Early Phase 1
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form.
- Inclusive criteria are:
- 18-75 years of age
- ASA physical status I-III
- BMI < 35 kg/m2
Who cannot join
- all open shoulder procedures
- patient having difficulty understanding the instruction on using the anesthetic infusion pump
- contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy)
- significant neurologic disorders of the upper extremity
- psychiatric or cognitive disorders
- history of substance abuse or chronic opioid use
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital
New York, New York, 10025
About this study
Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.
- Conditions
- Rotator Cuff Injury
- Being tested
- Baxter INFUSOR System, Single Injection of Local Anesthetic
- Keywords
- shoulder arthroscopy, 24-week follow-up, quality of life, rehabilitation achievement, rotator cuff repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baxter INFUSOR SystemDevice
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
Single Injection of Local AnestheticDrug
Single injection of 20 ml ropivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Baxter INFUSOR System | Experimental | Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia Receives: Drug: Single Injection of Local Anesthetic |
| Single Injection of Local Anesthetic | Active comparator | Single injection of 20 ml ropivacaine 0.5% Receives: Device: Baxter INFUSOR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
To describe rehabilitation achievement and quality of life during 24-week follow-up after shoulder arthroscopy and rotator cuff repair, and identify any association between type of anesthesia procedure and patients' quality of life
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuryStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Admir Hadzic, St. Luke's-Roosevelt Hospital Center
- Investigators
- Admir Hadzic, MD PhD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355757
- Sponsor's protocol ID
- 10-142
- Status last verified
- May 2014
- First submitted
- 16 May 2011
- Last updated
- 19 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT01355757
- Acronym / sponsor ID
- 10-142
- Conditions
- Rotator Cuff Injury
- Keywords
- shoulder arthroscopy, 24-week follow-up, quality of life, rehabilitation achievement, rotator cuff repair
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 May 2011 (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.
Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baxter INFUSOR System | Experimental | Drug: Single Injection of Local AnestheticRegional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia |
| Single Injection of Local Anesthetic | Active comparator | Device: Baxter INFUSOR SystemSingle injection of 20 ml ropivacaine 0.5% |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form.
- 18-75 years of age
- ASA physical status I-III
- BMI < 35 kg/m2
Key exclusion criteria (6 listed)
- all open shoulder procedures
- patient having difficulty understanding the instruction on using the anesthetic infusion pump
- contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy)
- significant neurologic disorders of the upper extremity
- psychiatric or cognitive disorders
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 |
|---|---|---|
| Baxter INFUSOR SystemRegional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia | Device | Single Injection of Local Anesthetic |
| Single Injection of Local AnestheticSingle injection of 20 ml ropivacaine 0.5% | Drug | Baxter INFUSOR System |
Primary outcome
Quality of Life
Time frame: 24 weeks
To describe rehabilitation achievement and quality of life during 24-week follow-up after shoulder arthroscopy and rotator cuff repair, and identify any association between type of anesthesia procedure and patients' quality of life
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 19 May 2014.
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Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.
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RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
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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.
Admir Hadzic, MD PhD principal investigator
St. Luke's-Roosevelt Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Baxter INFUSOR System and Single Injection of Local Anesthetic in people with Rotator Cuff Injury, run by St. Luke's-Roosevelt Hospital Center 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 6 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 19 May 2014. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of Life (time frame: 24 weeks). 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 19 May 2014; AzTrials last refreshed its copy on 2 Nov 2026.