Poonam Pai B H1, Dina Diskina2, Hung Mo Lin1, Ettore Vulcano3, Yan H Lai4. 1. Mount Sinai Health System, New York, NY, USA. 2. NYU Langone Health, New York, NY, USA. 3. Mount Sinai Medical Center, Columbia University, Miami, FL, USA. 4. Department of Anesthesiology, Mount Sinai Health System, 1000 Tenth Avenue, New York, NY, 10019, USA. Yan.Lai@mountsinai.org.
Abstract
STUDY OBJECTIVE: TXA is an antifibrinolytic medication widely used to reduce perioperative blood loss, but it has been seldom used during foot and ankle surgery. Our study evaluates the impact of TXA use on blood loss, post-operative pain, peri-operative opioid consumption, and wound healing in ambulatory outpatient foot and ankle procedures. DESIGN: Prospective, triple-blinded, randomized controlled trial. SETTING: Peri-operative environment of a major academic health centre in New York City. PATIENTS: A total of 100 participants who were scheduled for ambulatory foot and ankle surgery with a single surgeon. INTERVENTIONS: Patients receive either 10 mg/kg TXA (TXA group) or 10 ml/kg of normal saline (placebo group) intravenously prior to skin incision. MEASUREMENTS: Primary outcome was intra-operative blood loss. Secondary outcomes were peri-operative opioid consumption and wound complications between post-operative days 14 and 21. MAIN RESULTS: We found no difference between TXA and placebo groups in terms of intra-operative blood loss, p value 0.71, 95% CI (63.13-19.80). There was no difference between the two groups in terms of post-operative morphine milliequivalents (MME). The incidence of wound complications was 16.3% in the TXA group compared to 15.7% in the placebo group with OR 1.04, p value 0.93, 95% CI (0.32-2.77). No adverse events associated with TXA were reported. CONCLUSIONS: The use of TXA during foot and ankle surgery was not associated with any benefits in perioperative outcomes in our outpatient ambulatory surgical population. Considering potential risks, we do not support the routine use of TXA in this surgical model.
STUDY OBJECTIVE: TXA is an antifibrinolytic medication widely used to reduce perioperative blood loss, but it has been seldom used during foot and ankle surgery. Our study evaluates the impact of TXA use on blood loss, post-operative pain, peri-operative opioid consumption, and wound healing in ambulatory outpatient foot and ankle procedures. DESIGN: Prospective, triple-blinded, randomized controlled trial. SETTING: Peri-operative environment of a major academic health centre in New York City. PATIENTS: A total of 100 participants who were scheduled for ambulatory foot and ankle surgery with a single surgeon. INTERVENTIONS: Patients receive either 10 mg/kg TXA (TXA group) or 10 ml/kg of normal saline (placebo group) intravenously prior to skin incision. MEASUREMENTS: Primary outcome was intra-operative blood loss. Secondary outcomes were peri-operative opioid consumption and wound complications between post-operative days 14 and 21. MAIN RESULTS: We found no difference between TXA and placebo groups in terms of intra-operative blood loss, p value 0.71, 95% CI (63.13-19.80). There was no difference between the two groups in terms of post-operative morphine milliequivalents (MME). The incidence of wound complications was 16.3% in the TXA group compared to 15.7% in the placebo group with OR 1.04, p value 0.93, 95% CI (0.32-2.77). No adverse events associated with TXA were reported. CONCLUSIONS: The use of TXA during foot and ankle surgery was not associated with any benefits in perioperative outcomes in our outpatient ambulatory surgical population. Considering potential risks, we do not support the routine use of TXA in this surgical model.
Authors: Monique E R van Meegeren; Goris Roosendaal; Nathalie W D Jansen; Floris P J G Lafeber; Simon C Mastbergen Journal: Cartilage Date: 2013-10 Impact factor: 4.634