Clinical trial NCT05302986: Effect on Post-operative Pain of Tranexamic Acid Injection During Shoulder Surgery
Official title: Benefits on Post-operative Pain of Intravenous, Intraoperative, Tranexamic Acid Injection During Arthroscopic Shoulder Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Shoulder Disease
Keywords: Shoulder
Pain
Arthroscopic shoulder surgery
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
timeFrame: At 24 hours post-operative
Secondary outcomes:
measure: Evaluation of postoperative shoulder pain between the two groups
timeFrame: At 24 hours and 7 days after surgery
measure: Evaluation of patient satisfaction between the two groups
timeFrame: The day after surgery
measure: Assessment of shoulder functionality between the two groups
timeFrame: Before surgery and at the day 30 after surgery
measure: Assessment of shoulder functionality between the two groups
timeFrame: Before surgery and at the day 30 after surgery
measure: Evaluation of the safety of the treatments under study between the two groups
timeFrame: Continuously from surgery up to 30 days after surgery
Other outcomes:
Locations:
city: Bruges
country: France
facility: Polyclinique Jean Villar
Study officials:
References:
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.
citation: 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 Jan 6. French.
citation: Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
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. Arthroscopy. 2020 Mar;36(3):640-647. doi: 10.1016/j.arthro.2019.10.020. Epub 2019 Dec 20.