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

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04419246
• Other study ID #: Bursa BYIERH
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: June 2020
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Korgün Ökmen, Assoc. PhD.
• Phone: +902242955000
• Email: korgunokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block
• Tranexamic Acid

Intervention

Other:
• interscalene block
ultrasound guided ultrasound guided interscalene block 30 minutes before operation. 30 minutes before operation.

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

Other:
• general anesthesia
general anesthesia will be applied in accordance with standard procedures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum hemoglobin exchange	change of serum hemoglobin before and after operation	preoperative, postoperative 1st and 2nd day
Secondary	postoperative bleeding amount	The volume of drainage	postoperative 24 hours
Secondary	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