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

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

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.

Study Overview

• Status: Unknown
• Conditions: Nerve Block; Tranexamic Acid
• Intervention / Treatment: Other: interscalene block; Other: general anesthesia; Drug: tranexamic acid

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Korgün Ökmen, Assoc. PhD.; Phone Number: +902242955000; Email: korgunokmen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2020
• Primary Completion (Anticipated): July 15, 2020
• Study Completion (Anticipated): July 15, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 6, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: Bursa BYIERH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No