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

NCT05302986 | Completed Phase 3

• 2 other identifiers: ASCOT2021-005710-34
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Disease

Keywords

Shoulder; Pain; Arthroscopic shoulder surgery

Outcome Measures

Primary Outcomes (1)

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

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

  At 24 hours post-operative

Secondary Outcomes (5)

• Evaluation of postoperative shoulder pain between the two groups

  At 24 hours and 7 days after surgery

• Evaluation of patient satisfaction between the two groups

  The day after surgery

• Assessment of shoulder functionality between the two groups

  Before surgery and at the day 30 after surgery

• Assessment of shoulder functionality between the two groups

  Before surgery and at the day 30 after surgery

• Evaluation of the safety of the treatments under study between the two groups

  Continuously from surgery up to 30 days after surgery

Study Arms (2)

Surgery with intravenous injection of tranexamic acid

EXPERIMENTAL

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.

Drug: Tranexamic acid injection

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Surgery with intravenous injection of tranexamic acid

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Polyclinique Jean Villar

Bruges, France, 33520, France

Location

Related Publications (4)

• 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.

  PMID: 33475421 RESULT

• 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.

  PMID: 21215592 RESULT

• Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

  PMID: 3791738 RESULT

• 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.

  PMID: 31870749 RESULT

Related Links

• Tranexamic acid (TXA) is widely used across surgical specialties to reduce perioperative bleeding.
• Tranexamic acid (TxA) reduces total blood losses (TBL) and allogenic transfusion (TH) after total knee arthroplasty (TKA).
• Several methods have been devised to estimate shoulder function.
• To determine whether intravenous administration of tranexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity.

MeSH Terms

Conditions

Pain

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 31, 2022
• Study Start: February 24, 2023
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)