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Benefits on Post-operative Pain of Intravenous, Intraoperative, Tranexamic Acid Injection During Arthroscopic Shoulder Surgery.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518947-40-01
Acronym
ASCOT
Enrollment
220
Registered
2025-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient requiring shoulder arthroscopy

Brief summary

Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).

Detailed description

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), Satisfaction will be assessed through an Evaluation of the Experience of General Anesthesia questionnaire., The functionality of the shoulder will be evaluated at 30 days by the Subjective Shoulder Value scale and and Constant Score., Collection of adverse events throughout the duration of the study.

Interventions

DRUGEXACYL 0
DRUG5 g/5 ml I.V.
DRUGsolution injectable
DRUGCHLORURE DE SODIUM 0

Sponsors

Aquitaine Sante
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).

Secondary

MeasureTime frame
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), Satisfaction will be assessed through an Evaluation of the Experience of General Anesthesia questionnaire., The functionality of the shoulder will be evaluated at 30 days by the Subjective Shoulder Value scale and and Constant Score., Collection of adverse events throughout the duration of the study.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026