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Effect of local Tranexamic Acid on bleeding in Nose Surgery: A Study in Adults with Deviated Septum

Effect of local tranexamic acid on bleeding, surgical field quality and Surgeon's satisfaction during septoplastic surgery: Randomized controlled trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001186448
Enrollment
108
Registered
2025-10-29
Start date
2024-10-02
Completion date
2025-07-01
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study investigated whether adding tranexamic acid to the standard local anesthetic during septoplasty (nose surgery) reduces bleeding and improves the surgical field. We hypothesized that local tranexamic acid would significantly decrease blood loss, enhance surgical conditions, and increase surgeon satisfaction without raising risks.

Interventions

The intervention group will receive the intervention solution: The intervention solution contained 5 ml 2% lidocaine and 0.5 ml epinephrine 1:100,000 plus 1 ml tranexamic acid (100 mg). The intervention solution was given as a local injection into the septum mucosa using a syringe before the incision (as is usual in septoplasty). The injection was performed by the same otolaryngologist who performed the surgery. It was given once at the beginning of the procedure. The method of administration i

The intervention group will receive the intervention solution: The intervention solution contained 5 ml 2% lidocaine and 0.5 ml epinephrine 1:100,000 plus 1 ml tranexamic acid (100 mg). The intervention solution was given as a local injection into the septum mucosa using a syringe before the incision (as is usual in septoplasty). The injection was performed by the same otolaryngologist who performed the surgery. It was given once at the beginning of the procedure. The method of administration is local injection via syringe. The injection protocol comprised a standardized volume of 10 ml for both groups. Distilled water was used as the diluent to achieve the target volume. In both groups, the surgeon administered the agent as a local injection within the surgical field.

Sponsors

Damascus University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria comprised patients scheduled for elective septoplasty who met ASA physical status class I and were aged between 18 and 60 years.

Exclusion criteria

Exclusion criteria included: refusal to participate; patients with ASA class II or higher; impaired coagulation tests; history of thromboembolism or bleeding disorders; thrombocytopenia (low platelet count); documented use of anticoagulant medications; previous nasal surgery; concurrent rhinoplasty, sinus surgery, or turbinate surgery during septal repair; and known allergy to tranexamic acid.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026