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

NCT ID: NCT04419246

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2021-07-15

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.

Conditions

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Nerve Block Tranexamic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group I

interscalene block + General anesthesia

Group Type ACTIVE_COMPARATOR

interscalene block

Intervention Type OTHER

ultrasound guided ultrasound guided interscalene block 30 minutes before operation. 30 minutes before operation.

general anesthesia

Intervention Type OTHER

general anesthesia will be applied in accordance with standard procedures

Group T

Tranexamic acid +General anesthesia

Group Type ACTIVE_COMPARATOR

tranexamic acid

Intervention Type DRUG

10 mg/kg intravenous tranexamic acid 10 minutes before the incision.

general anesthesia

Intervention Type OTHER

general anesthesia will be applied in accordance with standard procedures

Group S

General anesthesia

Group Type SHAM_COMPARATOR

general anesthesia

Intervention Type OTHER

general anesthesia will be applied in accordance with standard procedures

Interventions

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interscalene block

ultrasound guided ultrasound guided interscalene block 30 minutes before operation. 30 minutes before operation.

Intervention Type OTHER

tranexamic acid

10 mg/kg intravenous tranexamic acid 10 minutes before the incision.

Intervention Type DRUG

general anesthesia

general anesthesia will be applied in accordance with standard procedures

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Korgün Ökmen

Principal Investigator ,Assoc. PhD. M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Korgün Ökmen, Assoc. PhD.

Role: CONTACT

+902242955000

Other Identifiers

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Bursa BYIERH

Identifier Type: -

Identifier Source: org_study_id

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