Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial

Abstract

ObjectiveDuloxetine has been recently used as a part of multimodal analgesia in perioperative settings, yet the optimal dose of Duloxetine is not determined. DesignA parallel, randomized, placebo-controlled trial. SettingTertiary level oncology center. Patients88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited. InterventionParticipants were randomly allocated into 4 equal groups received 2 h preoperatively, placebo (D0, N = 22), Duloxetine 30 mg (D30, N = 22), Duloxetine 60 mg (D60, N = 22) and Duloxetine 90 mg (D90, N = 22) tablet. MeasurementsThe primary outcome; 24 h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting) were measured. ResultsThe median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0–6) vs. 10(9–12), D60 vs. D30; 0(0–6) vs. 9(8–11), D90 vs. D0; 0(0–5) vs. 10(9–12), D90 vs. D30; 0(0–5) vs. 9(8–11), D90 vs. D60; 0(0–5) vs. 0(0–6), D30 vs. D0; 9(8–11) vs. 10(9–12), patients in D90 group took longer time to recover from anesthesia “ time to Aldrete 9” and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group. ConclusionPreoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects. Trial registrationThe trial was registered at Clinical Trials.gov with unique ID number; NCT03468348.