Skip to main content
OpenTrials
Completed

NCT Number: NCT05302986

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Disease Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Polyclinique Jean Villar

Bruges, France, 33520

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • - 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.

Treatment and study plan

Tranexamic acid injection

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.

Placebo

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.

Primary outcomes

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

    Time frame: At 24 hours post-operative

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

Secondary outcomes

  1. Evaluation of postoperative shoulder pain between the two groups

    Time frame: At 24 hours and 7 days after surgery

    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)

  2. Evaluation of patient satisfaction between the two groups

    Time frame: The day after surgery

    Satisfaction will be assessed through an Evaluation of the Experience of General Anesthesia questionnaire.

  3. Assessment of shoulder functionality between the two groups

    Time frame: Before surgery and at the day 30 after surgery

    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%.

  4. Assessment of shoulder functionality between the two groups

    Time frame: Before surgery and at the day 30 after surgery

    The functionality of the shoulder will be evaluated by the Constant Score.

  5. Evaluation of the safety of the treatments under study between the two groups

    Time frame: Continuously from surgery up to 30 days after surgery

    Collection of adverse events throughout the duration of the study.

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

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

Acronym: ASCOT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.