Shoulder ArthroscopyPhase 4NCT05244525
Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
A Phase 4 study testing Bupivacaine with Epinephrine and Bupivacaine alone in people with Shoulder Arthroscopy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate surgeon-rated visual clarity and the need for increased irrigation pump pressure during arthroscopic shoulder surgery and to evaluate mean arterial pressure, operative time, and any adverse events that occur during arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroscopy
- What is being tested?
- Bupivacaine with Epinephrine and Bupivacaine alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 31 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position requiring visualization within the subacromial space
Who cannot join
- Are unable to provide informed consent
- Non-English speaker
- Have a history of adverse medication reaction to epinephrine
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to evaluate surgeon-rated visual clarity and the need for increased irrigation pump pressure during arthroscopic shoulder surgery and to evaluate mean arterial pressure, operative time, and any adverse events that occur during arthroscopic shoulder surgery.
- Conditions
- Shoulder Arthroscopy
- Being tested
- Bupivacaine with Epinephrine, Bupivacaine alone
- Keywords
- Shoulder, Rotator Cuff, Epinephrine, Subacromial bursa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine with EpinephrineDrug
Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Study patients will receive an injection containing a total volume of 20 mL of bupivacaine with epinephrine (0.3 mL epinephrine in 30 mL of 0.5% bupivacaine).The syringe will not be labeled, and the contents of the injection will not be disclosed to the surgeon to preserve blinding. The injection will be performed with an 18-gauge needle into the subacromial space via a posterior or lateral approach after positioning the patient in the beach chair position, but prior to prepping and draping.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale. Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.
Bupivacaine aloneDrug
Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Control patients will receive an injection containing 20mL of 0.5% bupivacaine alone.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale.Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Bupivacaine with Epinephrine |
| Control Group | Active comparator | Not described Receives: Drug: Bupivacaine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale
This scale is scored from 1-10, a higher number indicating better clarity
Measured: end of surgery(about 30-120 minutes from start of surgery)
Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure
The pump pressure is initially set at 35mmHg during the arthroscopic surgical procedure. If visualization is limited during the procedure, surgeons may increase the pump pressure of arthroscopic fluid within the shoulder during the procedure. This outcome measure reports the percentage of participants for whom intra-operative arthroscopic pump pressure was increased to 45mmHg or higher during the surgical procedure.
Measured: From start of surgery to end of surgery(about 30-120 minutes)
Secondary outcomes (4)
Intraoperative Mean Arterial Pressure
Measured: end of surgery(about 30-120 minutes from start of surgery)
Total Operative Time
Measured: end of surgery(about 30-120 minutes from start of surgery)
Number of Subjects Who Experience Intraoperative Adverse Events
Measured: end of surgery(about 30-120 minutes from start of surgery)
Number of Subjects Who Experience Post Operative Adverse Events
Measured: from the end of surgery up to 2 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start14 Mar 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James M. Gregory, The University of Texas Health Science Center, Houston
- Investigators
- James M Gregory, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244525
- Sponsor's protocol ID
- HSC-MS-21-1061
- Status last verified
- Oct 2023
- First submitted
- 8 Feb 2022
- Last updated
- 3 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feinstein S, Svetgoff RA, Harmon J, Siahaan J, Ngo DH, Fullick RK, Flores SE, Shupe PG, Gregory BP, Gregory JM. Effect of a Preoperative Subacromial Epinephrine Injection on Visualization During Shoulder Arthroscopic Surgery: A Randomized Controlled Trial. Orthop J Sports Med. 2024 Oct 10;12(10):23259671241278247. doi: 10.1177/23259671241278247. eCollection 2024 Oct.
PubMed 39399770
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT05244525
- Acronym / sponsor ID
- HSC-MS-21-1061
- Conditions
- Shoulder Arthroscopy
- Keywords
- Shoulder, Rotator Cuff, Epinephrine, Subacromial bursa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Posted 3 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate surgeon-rated visual clarity and the need for increased irrigation pump pressure during arthroscopic shoulder surgery and to evaluate mean arterial pressure, operative time, and any adverse events that occur during arthroscopic shoulder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Bupivacaine with Epinephrine |
| Control Group | Active comparator | Drug: Bupivacaine alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position requiring visualization within the subacromial space
Key exclusion criteria (3 listed)
- Are unable to provide informed consent
- Non-English speaker
- Have a history of adverse medication reaction to epinephrine
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 |
|---|---|---|
| Bupivacaine with EpinephrineRandomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Study patients will receive an injection containing a total volume of 20 mL of bupivacaine with epinephrine (0.3 mL epinephrine in 30 mL of 0.5% bupivacaine).The syringe will not be labeled, and the contents of the injection will not be disclosed to the surgeon to preserve blinding. The injection will be performed with an 18-gauge needle into the subacromial space via a posterior or lateral approach after positioning the patient in the beach chair position, but prior to prepping and draping.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale. Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded. | Drug | Treatment |
| Bupivacaine aloneRandomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Control patients will receive an injection containing 20mL of 0.5% bupivacaine alone.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale.Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded. | Drug | Control Group |
Primary outcome
Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale
Time frame: end of surgery(about 30-120 minutes from start of surgery)
This scale is scored from 1-10, a higher number indicating better clarity
Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure
Time frame: From start of surgery to end of surgery(about 30-120 minutes)
The pump pressure is initially set at 35mmHg during the arthroscopic surgical procedure. If visualization is limited during the procedure, surgeons may increase the pump pressure of arthroscopic fluid within the shoulder during the procedure. This outcome measure reports the percentage of participants for whom intra-operative arthroscopic pump pressure was increased to 45mmHg or higher during the surgical procedure.
4 secondary outcomes
Intraoperative Mean Arterial Pressure
Time frame: end of surgery(about 30-120 minutes from start of surgery)
Total Operative Time
Time frame: end of surgery(about 30-120 minutes from start of surgery)
Number of Subjects Who Experience Intraoperative Adverse Events
Time frame: end of surgery(about 30-120 minutes from start of surgery)
Number of Subjects Who Experience Post Operative Adverse Events
Time frame: from the end of surgery up to 2 weeks post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39399770Feinstein S, Svetgoff RA, Harmon J, Siahaan J, Ngo DH, Fullick RK, Flores SE, Shupe PG, Gregory BP, Gregory JM. Effect of a Preoperative Subacromial Epinephrine Injection on Visualization During Shoulder Arthroscopic Surgery: A Randomized Controlled Trial. Orthop J Sports Med. 2024 Oct 10;12(10):23259671241278247. doi: 10.1177/23259671241278247. eCollection 2024 Oct.
- Individual participant dataSharing planned: No
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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.
James M Gregory, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine with Epinephrine and Bupivacaine alone in people with Shoulder Arthroscopy, run by The University of Texas Health Science Center, Houston 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 3 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 Nov 2023. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale (time frame: end of surgery(about 30-120 minutes from start of surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244525, which also lists 1 linked publication.
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 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.