Visualization in Shoulder ArthroscopyNCT01973699
Visualization in Shoulder Arthroscopy With and Without Epinephrine
A study testing visualization in shoulder arthroscopy in people with Visualization in Shoulder Arthroscopy, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial summary
Adequate visualization during shoulder arthroscopy is of great importance for the procedure to be efficiently and effectively performed. The use of dilute epinephrine in irrigation fluid has been historically utilized to help with visualization. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Visualization in Shoulder Arthroscopy
- What is being tested?
- visualization in shoulder arthroscopy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2013
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients requiring shoulder arthroscopy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18015
About this study
Official title: Surgeon Determined Visualization in Shoulder Arthroscopy: A Randomized, Blinded, Controlled Trial Comparing Irrigation Fluid With and Without Epinephrine
Adequate visualization during shoulder arthroscopy is of great importance for the procedure to be efficiently and effectively performed. The use of dilute epinephrine in irrigation fluid has been historically utilized to help with visualization. Given the potential safety issues documented in the literature related to epinephrine use, as well as the significant improvements in technique and instrumentation over the last decade, the need for this additive should be reexamined. The objective of the current study was to compare surgeon determined visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine.
- Conditions
- Visualization in Shoulder Arthroscopy
- Being tested
- visualization in shoulder arthroscopy
- Keywords
- shoulder arthroscopy, epinephrine, visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visualization in shoulder arthroscopyOther
Evaluating the effect of performing shoulder arthroscopy with and without epinephrine on visualization
| Study group | Role | What they receive |
|---|---|---|
| With Epinephrine | Placebo comparator | Patients undergoing shoulder arthroscopy with epinephrine in their irrigation as standardly performed Receives: Other: visualization in shoulder arthroscopy |
| Without Epinephrine | Experimental | Patients undergoing shoulder arthroscopy without epinephrine in their irrigation fluid as typically done Receives: Other: visualization in shoulder arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization
surgeon determined visualization during shoulder arthroscopy as judged by a VAS
Measured: November 1, 2012- April 1, 2013 (5 months)
Secondary outcomes (2)
Fluid Use
fluid used during arthroscopy
Measured: November 1, 2012-April 1, 2013 (5 months)
Operative time
operative time
Measured: November 1, 2012-April 1, 2013 (5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visualization in Shoulder ArthroscopyStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory F Carolan, MD, Principal investigator, St. Luke's University Hospital and Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973699
- Sponsor's protocol ID
- SLHN 2012-61
- Status last verified
- Dec 2015
- First submitted
- 25 Oct 2013
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeon Determined Visualization in Shoulder Arthroscopy: A Randomized, Blinded, Controlled Trial Comparing Irrigation Fluid With and Without Epinephrine
- ClinicalTrials.gov ID
- NCT01973699
- Acronym / sponsor ID
- SLHN 2012-61
- Conditions
- Visualization in Shoulder Arthroscopy
- Keywords
- shoulder arthroscopy, epinephrine, visualization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 31 Oct 2013 (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.
Adequate visualization during shoulder arthroscopy is of great importance for the procedure to be efficiently and effectively performed. The use of dilute epinephrine in irrigation fluid has been historically utilized to help with visualization. Given the potential safety issues documented in the literature related to epinephrine use, as well as the significant improvements in technique and instrumentation over the last decade, the need for this additive should be reexamined. The objective of the current study was to compare surgeon determined visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Epinephrine | Placebo comparator | Other: visualization in shoulder arthroscopyPatients undergoing shoulder arthroscopy with epinephrine in their irrigation as standardly performed |
| Without Epinephrine | Experimental | Other: visualization in shoulder arthroscopyPatients undergoing shoulder arthroscopy without epinephrine in their irrigation fluid as typically done |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients requiring shoulder arthroscopy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| visualization in shoulder arthroscopyEvaluating the effect of performing shoulder arthroscopy with and without epinephrine on visualization | Other | With Epinephrine, Without Epinephrine |
Primary outcome
Visualization
Time frame: November 1, 2012- April 1, 2013 (5 months)
surgeon determined visualization during shoulder arthroscopy as judged by a VAS
2 secondary outcomes
Fluid Use
Time frame: November 1, 2012-April 1, 2013 (5 months)
Operative time
Time frame: November 1, 2012-April 1, 2013 (5 months)
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 Jan 2016.
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.
Gregory F Carolan, MD principal investigator
St. Luke's University Hospital and Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visualization in shoulder arthroscopy in people with Visualization in Shoulder Arthroscopy, run by St. Luke's Hospital, Pennsylvania 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 1 Jan 2016. 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. Some participants in this study may receive a placebo. 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?
Visualization (time frame: November 1, 2012- April 1, 2013 (5 months)). 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 Jan 2016.