Effect on Post-operative Pain of Tranexamic Acid Injection During Shoulder Surgery

Shoulder Disease Clinical Trial

— ASCOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302986
• Other study ID #: ASCOT
• Secondary ID: 2021-005710-34
• Status: Recruiting
• Phase: Phase 3
• Start date: February 24, 2023
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Elsan
• Contact: Hugues Demezon, MD
• Phone: 05 35 54 95 69
• Email: huguesdemezon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Shoulder Disease

Intervention

Drug:
• 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 during the shoulder surgery.
• Placebo
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.

Locations

Country	Name	City	State
France	Polyclinique Jean Villar	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

References & Publications (4)

Chevet 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 — View Citation

Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4. — View Citation

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. — View Citation

Liu 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. Arthr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At 24 hours post-operative
Secondary	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)	At 24 hours and 7 days after surgery
Secondary	Evaluation of patient satisfaction between the two groups	Satisfaction will be assessed through an Evaluation of the Experience of General Anesthesia questionnaire.	The day after surgery
Secondary	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%.	Before surgery and at the day 30 after surgery
Secondary	Assessment of shoulder functionality between the two groups	The functionality of the shoulder will be evaluated by the Constant Score.	Before surgery and at the day 30 after surgery
Secondary	Evaluation of the safety of the treatments under study between the two groups	Collection of adverse events throughout the duration of the study.	Continuously from surgery up to 30 days after surgery

External Links

•   Several methods have been devised to estimate shoulder function.
•   To determine whether intravenous administration of tranexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity.
•   Tranexamic acid (TXA) is widely used across surgical specialties to reduce perioperative bleeding.
•   Tranexamic acid (TxA) reduces total blood losses (TBL) and allogenic transfusion (TH) after total knee arthroplasty (TKA).