None listed
Conditions
Brief summary
This study evaluates the effect of intravenous tranexamic acid (TXA) on surgical field clarity during hand surgeries performed under tumescent anesthesia in a WALANT setting. Although epinephrine in tumescent solution provides vasoconstriction, microvascular oozing can still impair visualization and prolong operative time. TXA, an antifibrinolytic agent, stabilizes fibrin clots and has been shown to reduce intraoperative bleeding and improve operative conditions in various surgical specialties. The trial aims to compare standard tumescent anesthesia alone versus tumescent anesthesia combined with intravenous TXA in terms of surgical field visibility and operative efficiency. The findings may help determine whether adjunctive IV TXA improves hemostasis and operative field clarity in hand surgery.
Interventions
Group A: Tumescent anaesthesia with supplemental intravenous tranexamic acid
Patients in Group A will receive tumescent anaesthesia using Klein’s solution, prepared with 20 millilitres of 2% lidocaine, 1 millilitre of epinephrine at a concentration of 1:1,000, 10 milliequivalents of sodium bicarbonate, and 100 millilitres of normal saline. This will yield a final concentration of 0.4% lidocaine and epinephrine at 1:100,000.
In addition, intravenous tranexamic acid will be administered as a 10
Group A: Tumescent anaesthesia with supplemental intravenous tranexamic acid Patients in Group A will receive tumescent anaesthesia using Klein’s solution, prepared with 20 millilitres of 2% lidocaine, 1 millilitre of epinephrine at a concentration of 1:1,000, 10 milliequivalents of sodium bicarbonate, and 100 millilitres of normal saline. This will yield a final concentration of 0.4% lidocaine and epinephrine at 1:100,000. In addition, intravenous tranexamic acid will be administered as a 10 milligrams per kilogram bolus 15 minutes before the surgical incision. The primary surgeon, who will remain blinded to whether intravenous tranexamic acid has been administered, will assess and score operative field visual clarity at 15-minute intervals throughout the procedure. Blood loss will be quantified using a micropipette through a standardised 1-centimetre incision made at the beginning of surgery.
Sponsors
Muhammad Amar Akram-KEMU
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 19 and above (WHO defined terminology of ‘adults’) • Gender inclusive of male & female • Patients undergoing hand surgery due to trauma, post-burn contractures (mature burn scars being 3 yrs old or more), carpal tunnel release, trigger finger release, and Dupuytren's contracture release.
Exclusion criteria
• History of coagulopathy. • Receiving anticoagulation therapy or have received less than two weeks before surgery. • Deranged coagulation studies prior to surgery. • History of renal or liver disorders. • Uncontrolled hypertension. • Known allergy to local anesthetic agents or TXA. • Pregnant patients, given the unestablished safety profile of TXA.
Outcome results
None listed