Shoulder DiseasePhase 3ASCOTNCT05302986
Effect on Post-operative Pain of Tranexamic Acid Injection During Shoulder Surgery
A Phase 3 study testing Tranexamic acid injection in people with Shoulder Disease, run by Elsan at 1 site in France.
Trial summary
Arthroscopic shoulder surgery is a commonly performed minimally invasive surgery in which a camera (an arthroscope) is inserted inside the shoulder joint. This surgery is responsible for moderate to severe pain. It may require the use of opioid analgesics in the acute phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Disease
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2023to 25 Jul 2025
- 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
- 1 - Male or female aged 18 years old or more; 2- Patient requiring shoulder arthroscopy; 3 - Patient affiliated to a social security scheme; 4 - Patient informed on the study and who has signed the informed consent form.
Who cannot join
- - Tranexamic acid contraindications (Hypersensitivity to the active substance or to any of the excipients, Acute venous or arterial thrombosis, Severe renal impairment, History of convulsions);
- - Pregnant or breastfeeding patient;
- - Patient under legal protection;
- - Patient taking part simultaneously to another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits on Post-operative Pain of Intravenous, Intraoperative, Tranexamic Acid Injection During Arthroscopic Shoulder Surgery.
Arthroscopic shoulder surgery is a commonly performed minimally invasive surgery in which a camera (an arthroscope) is inserted inside the shoulder joint.
This surgery is responsible for moderate to severe pain. It may require the use of opioid analgesics in the acute phase. One of the components of this pain may be the postoperative hematoma.
Read more
Pain is one of the main causes of patient satisfaction failure after shoulder surgery. Finding ways to reduce this pain is a primary principle in the management of this surgery. Until now, this management requires the frequent use of morphine. However, this use of morphine may conduct to adverse effects (nausea/vomiting, constipation, malaise, sweating), and even public health problems such as addiction.
It is therefore interesting to look for ways to increase the patient's analgesia by other means, which will thus increase patient satisfaction and make his management more fluid. The effect on pain of hematoma reduction is rarely described in the scientific literature.
The hypothesis of this study is that the intraoperative administration of intravenous (IV) tranexamic acid can reduce the hematoma and thus decrease postoperative pain.The aim of this study is to demonstrate that the use of IV tranexamic acid intraoperatively, compared to a placebo (sodium chloride 0.9%), reduces postoperative pain after arthroscopic shoulder surgery.
- Conditions
- Shoulder Disease
- Being tested
- Tranexamic acid injection, Placebo
- Keywords
- Shoulder, Pain, Arthroscopic shoulder surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
The dose will be 0.1 mg / kg (= 10 mg/kg) and diluted in a 100 mL infusion bag of sodium chloride. The product will have to be administered as a slow infusion over 10 minutes during the shoulder surgery.
PlaceboDrug
Surgery with intravenous injection of Placebo (0.9% sodium chloride). A 100 mL infusion bag of sodium chloride will be administered as a slow infusion over 10 minutes during shoulder surgery.
| Study group | Role | What they receive |
|---|---|---|
| Surgery with intravenous injection of tranexamic acid | Experimental | The dose will be 0.1 mg / kg (= 10 mg/kg) and diluted in a 100 mL infusion bag of sodium chloride. The product will have to be administered as a slow infusion over 10 minutes. Receives: Drug: Tranexamic acid injection |
| Surgery with intravenous injection of Placebo (0.9% sodium chloride) | Placebo comparator | A 100 mL infusion bag of sodium chloride will be administered as a slow infusion over 10 minutes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
Measured: At 24 hours post-operative
Secondary outcomes (5)
Evaluation of postoperative shoulder pain between the two groups
Shoulder pain is assessed through a Visual Analog Scale (0-100) performed 24 hours post-operative and 7 days after surgery (online assessment with the help of software)
Measured: At 24 hours and 7 days after surgery
Evaluation of patient satisfaction between the two groups
Satisfaction will be assessed through an Evaluation of the Experience of General Anesthesia questionnaire.
Measured: The day after surgery
Assessment of shoulder functionality between the two groups
The functionality of the shoulder will be evaluated by the Subjective Shoulder Value scale.
Not normal shoulder that would scored 0% and normal shoulder that would scored 100%.
Measured: Before surgery and at the day 30 after surgery
Assessment of shoulder functionality between the two groups
The functionality of the shoulder will be evaluated by the Constant Score.
Measured: Before surgery and at the day 30 after surgery
Evaluation of the safety of the treatments under study between the two groups
Collection of adverse events throughout the duration of the study.
Measured: Continuously from surgery up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start24 Feb 2023
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Shoulder DiseaseStudies 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
- Model description
- Interventional, prospective, national monocentric study, randomized in parallel groups, comparative versus placebo, double-blind (patient and investigating surgeon). * Group 1: Surgery with intravenous injection of tranexamic acid * Group 2: Surgery with intravenous injection of Placebo (0.9% sodium chloride)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302986
- Sponsor's protocol ID
- ASCOT
- Other IDs
- 2021-005710-34
- Acronym
- ASCOT
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hartland AW, Teoh KH, Rashid MS. Clinical Effectiveness of Intraoperative Tranexamic Acid Use in Shoulder Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2021 Sep;49(11):3145-3154. doi: 10.1177/0363546520981679. Epub 2021 Jan 21.
PubMed 33475421Chevet I, Remerand F, Couvret C, Baud A, Pouplard C, Rosset P, Laffon M, Fusciardi J. [Tranexamic acid reduces haematomas but not pain after total knee arthroplasty]. Ann Fr Anesth Reanim. 2011 Jan;30(1):17-24. doi: 10.1016/j.annfar.2010.11.017. Epub 2011 Jan 6. French.
PubMed 21215592Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
PubMed 3791738Liu YF, Hong CK, Hsu KL, Kuan FC, Chen Y, Yeh ML, Su WR. Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of the Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-Blind, and Randomized Controlled Trial. Arthroscopy. 2020 Mar;36(3):640-647. doi: 10.1016/j.arthro.2019.10.020. Epub 2019 Dec 20.
PubMed 31870749
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits on Post-operative Pain of Intravenous, Intraoperative, Tranexamic Acid Injection During Arthroscopic Shoulder Surgery.
- ClinicalTrials.gov ID
- NCT05302986
- Acronym / sponsor ID
- ASCOT / ASCOT
- Conditions
- Shoulder Disease
- Keywords
- Shoulder, Pain, Arthroscopic shoulder surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 31 Mar 2022 (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.
Arthroscopic shoulder surgery is a commonly performed minimally invasive surgery in which a camera (an arthroscope) is inserted inside the shoulder joint.
This surgery is responsible for moderate to severe pain. It may require the use of opioid analgesics in the acute phase. One of the components of this pain may be the postoperative hematoma.
Pain is one of the main causes of patient satisfaction failure after shoulder surgery. Finding ways to reduce this pain is a primary principle in the management of this surgery. Until now, this management requires the frequent use of morphine. However, this use of morphine may conduct to adverse effects (nausea/vomiting, constipation, malaise, sweating), and even public health problems such as addiction.
It is therefore interesting to look for ways to increase the patient's analgesia by other means, which will thus increase patient satisfaction and make his management more fluid. The effect on pain of hematoma reduction is rarely described in the scientific literature.
The hypothesis of this study is that the intraoperative administration of intravenous (IV) tranexamic acid can reduce the hematoma and thus decrease postoperative pain.The aim of this study is to demonstrate that the use of IV tranexamic acid intraoperatively, compared to a placebo (sodium chloride 0.9%), reduces postoperative pain after arthroscopic shoulder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Interventional, prospective, national monocentric study, randomized in parallel groups, comparative versus placebo, double-blind (patient and investigating surgeon). * Group 1: Surgery with intravenous injection of tranexamic acid * Group 2: Surgery with intravenous injection of Placebo (0.9% sodium chloride)
| Arm | Type | Receives |
|---|---|---|
| Surgery with intravenous injection of tranexamic acid | Experimental | Drug: Tranexamic acid injectionThe dose will be 0.1 mg / kg (= 10 mg/kg) and diluted in a 100 mL infusion bag of sodium chloride. The product will have to be administered as a slow infusion over 10 minutes. |
| Surgery with intravenous injection of Placebo (0.9% sodium chloride) | Placebo comparator | Drug: PlaceboA 100 mL infusion bag of sodium chloride will be administered as a slow infusion over 10 minutes. |
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 - Male or female aged 18 years old or more; 2- Patient requiring shoulder arthroscopy; 3 - Patient affiliated to a social security scheme; 4 - Patient informed on the study and who has signed the informed consent form.
Key exclusion criteria (4 listed)
- - Tranexamic acid contraindications (Hypersensitivity to the active substance or to any of the excipients, Acute venous or arterial thrombosis, Severe renal impairment, History of convulsions);
- - Pregnant or breastfeeding patient;
- - Patient under legal protection;
- - Patient taking part simultaneously to another clinical trial.
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 |
|---|---|---|
| Tranexamic acid injectionThe dose will be 0.1 mg / kg (= 10 mg/kg) and diluted in a 100 mL infusion bag of sodium chloride. The product will have to be administered as a slow infusion over 10 minutes during the shoulder surgery. | Drug | Surgery with intravenous injection of tranexamic acid |
| PlaceboSurgery with intravenous injection of Placebo (0.9% sodium chloride). A 100 mL infusion bag of sodium chloride will be administered as a slow infusion over 10 minutes during shoulder surgery. | Drug | Surgery with intravenous injection of Placebo (0.9% sodium chloride) |
Primary outcome
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
Time frame: At 24 hours post-operative
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
5 secondary outcomes
Evaluation of postoperative shoulder pain between the two groups
Time frame: At 24 hours and 7 days after surgery
Evaluation of patient satisfaction between the two groups
Time frame: The day after surgery
Assessment of shoulder functionality between the two groups
Time frame: Before surgery and at the day 30 after surgery
Assessment of shoulder functionality between the two groups
Time frame: Before surgery and at the day 30 after surgery
Evaluation of the safety of the treatments under study between the two groups
Time frame: Continuously from surgery up to 30 days after 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 23 Apr 2026.
- Results publication: PubMed 33475421Hartland AW, Teoh KH, Rashid MS. Clinical Effectiveness of Intraoperative Tranexamic Acid Use in Shoulder Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2021 Sep;49(11):3145-3154. doi: 10.1177/0363546520981679. Epub 2021 Jan 21.
- Results publication: PubMed 21215592Chevet I, Remerand F, Couvret C, Baud A, Pouplard C, Rosset P, Laffon M, Fusciardi J. [Tranexamic acid reduces haematomas but not pain after total knee arthroplasty]. Ann Fr Anesth Reanim. 2011 Jan;30(1):17-24. doi: 10.1016/j.annfar.2010.11.017. Epub 2011 Jan 6. French.
- Results publication: PubMed 3791738Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
- Results publication: PubMed 31870749Liu YF, Hong CK, Hsu KL, Kuan FC, Chen Y, Yeh ML, Su WR. Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of the Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-Blind, and Randomized Controlled Trial. Arthroscopy. 2020 Mar;36(3):640-647. doi: 10.1016/j.arthro.2019.10.020. Epub 2019 Dec 20.
- Tranexamic acid (TXA) is widely used across surgical specialties to reduce perioperative bleeding.Link provided by the sponsor.
- Tranexamic acid (TxA) reduces total blood losses (TBL) and allogenic transfusion (TH) after total knee arthroplasty (TKA).Link provided by the sponsor.
- Several methods have been devised to estimate shoulder function.Link provided by the sponsor.
- To determine whether intravenous administration of tranexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity.Link provided by the sponsor.
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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.
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 Tranexamic acid injection in people with Shoulder Disease, run by Elsan at 1 site in France.
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 4 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 23 Apr 2026. 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 France. 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 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?
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no). (time frame: At 24 hours post-operative). 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 NCT05302986, which also lists 4 linked publications.
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 23 Apr 2026.