Re-Evaluating the Effect of Preoperative Tranexamic Acid on Blood Loss and Field Quality During Rhinoplasty: A Randomized Double-Blinded Controlled Trial

Overview

Bleeding during surgery is one of the main complicating factors in rhinoplasty, and previous trials reported that tranexamic acid reduces it. This trial re evaluated the drug's effect on blood loss during surgery and on the surgeon's view of the operating field. Patients were randomized and blinded, with the intervention group receiving 10 mg per kg of the drug and the placebo group an equal volume of normal saline.

Sections of note

• Randomized placebo controlled trial, registered as IRCT20111219008458N2; level of evidence I.
• Data from 80 patients were gathered and analysed.
• Blood loss was measured as the total volume collected by suction and gauze minus the irrigation fluid used.
• Surgical field quality was measured by surgeon satisfaction on a 5 point scale.
• Demographics, blood clotting measures and clinical data were collected and used as covariates.
• Blood loss was insignificantly lower in the drug group, mean difference minus 3.6, 95 percent confidence interval minus 19.19 to 11.99, P equals 0.65.
• Surgeon satisfaction was insignificantly higher in the drug group, mean difference 0.18, 95 percent confidence interval minus 0.11 to 0.46, P equals 0.22.
• Results were confirmed by multivariable analysis.

What it means for a patient

• The drug did not measurably reduce bleeding during surgery in this trial, contrary to most earlier studies.
• The confidence interval for blood loss spans zero widely, so a real effect in either direction has not been ruled out.
• Eighty patients is a modest sample for detecting a moderate effect.
• The authors state further studies are needed to estimate the drug's effect more precisely.

Why this paper matters

Tranexamic acid is given routinely by many rhinoplasty surgeons on the basis of earlier trials. This randomized double blinded study, the strongest design available, finds no significant benefit. Whether the drug helps in specific circumstances or at other doses remains open.

Terms

• Tranexamic acid: a drug that slows the breakdown of blood clots, used to reduce bleeding.
• Placebo: an inactive substance given for comparison, here normal saline.
• Double blinded: neither the patient nor the assessor knows which treatment was given.
• Surgical field quality: how clearly the surgeon can see the operating site, reduced by bleeding.
• Confidence interval: the range within which the true effect is likely to lie.