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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-24

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Shoulder Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional, prospective, national monocentric study, randomized in parallel groups, comparative versus placebo, double-blind (patient and investigating surgeon).

* Group 1: Surgery with intravenous injection of tranexamic acid
* Group 2: Surgery with intravenous injection of Placebo (0.9% sodium chloride)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The study will be conducted in a double-blind setting. The patient and the investigating surgeon will be blinded. The injection of the product will be performed by the anesthetist that will be aware of the injected product (tranexamic acid or sodium chloride).

Study Groups

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Surgery with intravenous injection of tranexamic acid

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.

Group Type EXPERIMENTAL

Tranexamic acid injection

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No