NCT04419246

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

Same day

First QC Date

June 3, 2020

Last Update Submit

June 6, 2020

Conditions

Nerve BlockTranexamic Acid

Outcome Measures

Primary Outcomes (1)

  • serum hemoglobin exchange

    change of serum hemoglobin before and after operation

    preoperative, postoperative 1st and 2nd day

Secondary Outcomes (2)

  • postoperative bleeding amount

    postoperative 24 hours

  • Visual Analog Scale

    Postoperative 24 hours

Study Arms (3)

Group I

ACTIVE COMPARATOR

interscalene block + General anesthesia

Other: interscalene blockOther: general anesthesia

Group T

ACTIVE COMPARATOR

Tranexamic acid +General anesthesia

Drug: tranexamic acidOther: general anesthesia

Group S

SHAM COMPARATOR

General anesthesia

Other: general anesthesia

Interventions

interscalene blockOTHER

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

Group I
tranexamic acidDRUG

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

Group T
general anesthesiaOTHER

general anesthesia will be applied in accordance with standard procedures

Group IGroup SGroup T

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • history of arterial or venous thromboembolic disease
  • Bleeding diathesis disorder
  • Allergy to local anesthetics
  • cardiac stent placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tranexamic AcidAnesthesia, General

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Korgün Ökmen, Assoc. PhD.

CONTACT

+902242955000korgunokmen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator ,Assoc. PhD. M.D.

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 5, 2020

Study Start

July 15, 2020

Primary Completion

July 15, 2020

Study Completion

July 15, 2021

Last Updated

June 9, 2020

Record last verified: 2020-06