The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy

Study Overview
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Brief Summary
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Nerve blocks are used for pain and surgery after many operations today. It has been demonstrated by studies that the amount of postoperative bleeding decreases. On the other hand, surgical teams can use additional medications, such as Tranexamic acid, which have been proven by different studies that have reduced bleeding during and after arthroscopic surgery.

Detailed Description
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The investigators aimed to investigate the effect of interscalene block application and tranexamic acid on bleeding in shoulder arthroscopy operation.

Official Title
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The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy on Total Blood Loss; a Prospective, Randomized, Controlled Trial

Conditions
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Nerve Block, Tranexamic Acid

Intervention / Treatment
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* Other: interscalene block
* Drug: tranexamic acid
* Other: general anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were in the American Society of Anesthesiologists (ASA) I-III class underwent elective shoulder arthroscopy Patients with consent to participate in the study Exclusion Criteria: history of arterial or venous thromboembolic disease Bleeding diathesis disorder Allergy to local anesthetics cardiac stent placement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>interscalene block + General anesthesia | Other: interscalene block<br>* ultrasound guided ultrasound guided interscalene block 30 minutes before operation. 30 minutes before operation.<br>Other: general anesthesia<br>* general anesthesia will be applied in accordance with standard procedures<br>|
| Active Comparator: Group T<br>Tranexamic acid +General anesthesia | Drug: tranexamic acid<br>* 10 mg/kg intravenous tranexamic acid 10 minutes before the incision.<br>Other: general anesthesia<br>* general anesthesia will be applied in accordance with standard procedures<br>|
| Sham Comparator: Group S<br>General anesthesia | Other: general anesthesia<br>* general anesthesia will be applied in accordance with standard procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum hemoglobin exchange | change of serum hemoglobin before and after operation | preoperative, postoperative 1st and 2nd day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative bleeding amount | The volume of drainage | postoperative 24 hours | 
| Visual Analog Scale | Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain) | Postoperative 24 hours |