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

Sponsor

Elsan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05302986

Collaborator

(none)

220

Enrollment

Location

Arms

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tranexamic acid exerts an anti-haemorrhagic activity by inhibiting the fibrinolytic properties of plasmin. A complex involving tranexamic acid, plasminogen is constituted; the tranexamic acid being linked to plasminogen when transformed into plasmin. The activity of the tranexamic acid-plasmin complex on the activity on fibrin is lower than the activity of free plasmin alone. In vitro studies showed that high tranexamic dosages decreased the activity of complement.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Drug: Tranexamic acid injection Drug: Placebo	Phase 3

Detailed Description

Arthroscopic shoulder surgery is a commonly performed minimally invasive surgery in which a camera (an arthroscope) is inserted inside the shoulder joint. Sterile fluid is continuously injected into the shoulder by an arthro-pump to create a working space and provide a clear view for the surgeon. The various incisions, which are then sutured, are used for the passage of the camera and the operating instruments dedicated to arthroscopy.

Arthroscopic surgery of the shoulder is recommended to treat problems such as rotator cuff lesions, calcification, acromioclavicular dislocation, biceps tendinopathy, subacromial impingement, acromioclavicular arthropathy, dislocations, etc.

This surgery is responsible for moderate to severe pain. It may require the use of opiate-type analgesics in the acute phase. One of the components of this pain may be 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 poses problems of comfort linked to undesirable 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 administration of intravenous (IV) tranexamic acid perioperatively can reduce the hematoma and thus decrease postoperative pain.

The aim of this study is to show that the use of IV tranexamic acid perioperatively, compared to a placebo (sodium chloride 0.9%), reduces postoperative pain after arthroscopic shoulder surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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)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)

Masking:

Double (Participant, Investigator)

Masking Description:

The study will be conducted double-blind. The patient and the investigating surgeon will be blinded. The injection of the product will be performed by the anesthesiologist, in the open.

Primary Purpose:

Treatment

Official Title:

Benefits on Post-operative Pain of Intraoperative Tranexamic Acid Administration.

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgery with intravenous injection of tranexamic acid For patients randomized in group 1, we can expect a clear decrease in pain during the first 24 hours with an associated decrease in the consumption of rescue analgesics during this same period. This decrease in pain, the main factor of patient dissatisfaction during this surgery, should be accentuated and associated with an increase in functional scores	Drug: Tranexamic acid injection Arthroscopy is a minimally invasive surgical procedure on a joint in which an examination and sometimes treatment of damage is performed using an arthroscope that is inserted into the joint through a small incision.
Placebo Comparator: Surgery with intravenous injection of Placebo (0.9% sodium chloride) Evaluate the benefit and the effect of the molecule compared to the placebo	Drug: Placebo Surgery with intravenous injection of Placebo (0.9% sodium chloride)

Arm

Intervention/Treatment

Experimental: Surgery with intravenous injection of tranexamic acid

For patients randomized in group 1, we can expect a clear decrease in pain during the first 24 hours with an associated decrease in the consumption of rescue analgesics during this same period. This decrease in pain, the main factor of patient dissatisfaction during this surgery, should be accentuated and associated with an increase in functional scores

Drug: Tranexamic acid injection

Arthroscopy is a minimally invasive surgical procedure on a joint in which an examination and sometimes treatment of damage is performed using an arthroscope that is inserted into the joint through a small incision.

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

Evaluate the benefit and the effect of the molecule compared to the placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no). [At 24 hours post-operative]
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).

Secondary Outcome Measures

Evaluation of postoperative shoulder pain between the two groups [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)
Evaluation of patient satisfaction between the two groups [The day after surgery]
Satisfaction will be assessed through an Evaluation of the Experience of General Anesthesia questionnaire.
Assessment of shoulder functionality between the two groups [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%.
Assessment of shoulder functionality between the two groups [Before surgery and at the day 30 after surgery]
The functionality of the shoulder will be evaluated by the Constant Score.
Evaluation of the safety of the treatments under study between the two groups [Continuously from surgery up to 30 days after surgery]
Collection of adverse events throughout the duration of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

- 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.