Reducing post-operative pain after shoulder surgery with tranexamic acid
Benefits on Post-operative Pain of Intravenous, Intraoperative, Tranexamic Acid Injection During Arthroscopic Shoulder Surgery.
This study is testing if an injection of tranexamic acid can help reduce pain after shoulder surgery and lower the need for opioid painkillers.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 1 site (Bruges) |
| Trial ID | NCT05302986 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of tranexamic acid injection in reducing post-operative pain following arthroscopic shoulder surgery. The study aims to determine if this intervention can minimize the need for opioid analgesics, which are commonly used but can lead to adverse effects and addiction. Participants will be randomly assigned to receive either the tranexamic acid injection or a placebo, allowing for a comparison of pain levels and patient satisfaction. The trial focuses on patients undergoing shoulder arthroscopy, a minimally invasive procedure that can result in significant pain due to postoperative hematoma.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require shoulder arthroscopy and are able to provide informed consent.
Not a fit: Patients with contraindications to tranexamic acid, such as severe renal impairment or those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and improve patient satisfaction while minimizing opioid use.
How similar studies have performed: While the use of tranexamic acid is well-established in other surgical contexts, its specific application for pain management in shoulder surgery is less common and may represent a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. - 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); 2. - Pregnant or breastfeeding patient; 3. - Patient under legal protection; 4. - Patient taking part simultaneously to another clinical trial.
Where this trial is running
Bruges
- Polyclinique Jean Villar — Bruges, France (Recruiting)
Study contacts
- Study coordinator: Hugues Demezon, MD
- Email: huguesdemezon@gmail.com
- Phone: 05 35 54 95 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.