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

Elsan

Status and phase: Enrolling; Phase 3

Conditions: Shoulder Disease

Treatments: Drug: Placebo; Drug: Tranexamic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05302986

ASCOT

2021-005710-34 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

220 participants in 2 patient groups, including a placebo group

Surgery with intravenous injection of tranexamic acid

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic acid injection

Surgery with intravenous injection of Placebo (0.9% sodium chloride)

Placebo Comparator group

Description:

A 100 mL infusion bag of sodium chloride will be administered as a slow infusion over 10 minutes.

Treatment:

Drug: Placebo