Intraoperative BleedingPhase 3NCT06264596
Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery
A Phase 3 study testing Epinephrine and Normal Saline irrigation fluid in people with Intraoperative Bleeding, run by The Guthrie Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Bleeding
- What is being tested?
- Epinephrine and Normal Saline irrigation fluid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Aug 2026
- Phase
- Phase 3
- 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
- Males and Females ages over 18 years
- Patients who undergo ankle arthroscopic surgery
- Patients who are able to read and give informed consent on their own behalf
Who cannot join
- Patients with any known cardiac diseases
- Uncontrolled hypertension (> 180/110 mmHg)
- Revision case
- Younger than 18 years of age
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Epinephrine in Irrigation Fluid for Visualization During Ankle Arthroscopy: A Randomized Blinded Controlled Trial
The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery.
Read the detailed description
The primary outcomes are:
- visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale from 0-10,
- and the intraoperative surgeon's discomfort related to bleeding, that will be measured by visual numeric rating scale from 0-3.
- Conditions
- Intraoperative Bleeding
- Being tested
- Epinephrine, Normal Saline irrigation fluid
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Also called Epinephrine in irrigation fluid
The epinephrine group will have two 3-L normal saline solution bags prepared for each case with 1 mL of 1:1000 epinephrine in each bag
Normal Saline irrigation fluidProcedure or surgery
The control group will have two 3-L normal saline solution bags prepared with no additive
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine | Experimental | The epinephrine group will have two 3-L normal saline solution bags prepared for each case with 1 mL of 1:1000 epinephrine in each bag (epinephrine concentration 1:3,000,000 for each bag). Receives: Drug: Epinephrine; Procedure: Normal Saline irrigation fluid |
| Normal saline | Placebo comparator | The control group will have two 3-L normal saline solution bags prepared with no additive Receives: Procedure: Normal Saline irrigation fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale
visual analog scale from 0-10
Measured: intraoperative
surgeon's discomfort related to bleeding, measured by visual numeric rating scale
visual numeric rating scale 0-3
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Why it stopped: Study never started. PI is leaving institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative BleedingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wonyong Lee, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264596
- Sponsor's protocol ID
- 2310-72
- Status last verified
- Oct 2024
- First submitted
- 9 Feb 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epinephrine in Irrigation Fluid for Visualization During Ankle Arthroscopy: A Randomized Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT06264596
- Acronym / sponsor ID
- 2310-72
- Conditions
- Intraoperative Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started. PI is leaving institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- 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.
The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery.
Detailed description
The primary outcomes are:
- visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale from 0-10,
- and the intraoperative surgeon's discomfort related to bleeding, that will be measured by visual numeric rating scale from 0-3.
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 |
|---|---|---|
| Epinephrine | Experimental | Drug: Epinephrine, Procedure: Normal Saline irrigation fluidThe epinephrine group will have two 3-L normal saline solution bags prepared for each case with 1 mL of 1:1000 epinephrine in each bag (epinephrine concentration 1:3,000,000 for each bag). |
| Normal saline | Placebo comparator | Procedure: Normal Saline irrigation fluidThe control group will have two 3-L normal saline solution bags prepared with no additive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females ages over 18 years
- Patients who undergo ankle arthroscopic surgery
- Patients who are able to read and give informed consent on their own behalf
Key exclusion criteria (5 listed)
- Patients with any known cardiac diseases
- Uncontrolled hypertension (> 180/110 mmHg)
- Revision case
- Younger than 18 years of age
- Pregnant women
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 |
|---|---|---|
| EpinephrineAlso: Epinephrine in irrigation fluidThe epinephrine group will have two 3-L normal saline solution bags prepared for each case with 1 mL of 1:1000 epinephrine in each bag | Drug | Epinephrine |
| Normal Saline irrigation fluidThe control group will have two 3-L normal saline solution bags prepared with no additive | Procedure or surgery | Epinephrine, Normal saline |
Primary outcome
visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale
Time frame: intraoperative
visual analog scale from 0-10
surgeon's discomfort related to bleeding, measured by visual numeric rating scale
Time frame: intraoperative
visual numeric rating scale 0-3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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.
Wonyong Lee, MD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epinephrine and Normal Saline irrigation fluid in people with Intraoperative Bleeding, run by The Guthrie Clinic 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 15 Oct 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale (time frame: intraoperative). 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?
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 15 Oct 2024.