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

Phase 3

Not yet recruiting

• Conditions: Patient requiring shoulder arthroscopy
• Interventions: Drug: Tranexamic acid injection; Drug: Placebo

• Registration Number: 2024-518947-40-01
• Lead Sponsor: Aquitaine Sante

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-07
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

Male or female aged 18 years old or more

Patient requiring shoulder arthroscopy

Patient affiliated to a social security scheme

Patient informed on the study and who has signed the informed consent form

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery with intravenous injection of tranexamic acid	Tranexamic acid injection	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.
Surgery with intravenous injection of Placebo (0.9% sodium chloride)	Placebo	A 100 mL infusion bag of sodium chloride will be administered as a slow infusion over 10 minutes.

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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)		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.		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.		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.		Collection of adverse events throughout the duration of the study.

Trial Locations

Locations (1)

Aquitaine Sante; 🇫🇷 Bruges, France

Aquitaine Sante

🇫🇷Bruges, France

Hugues DEMEZON

Site contact

0556161357

huguesdemezon@gmail.com