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

Duloxetine has been recently used as a part of multimodal analgesia in perioperative settings, yet the optimal dose of Duloxetine is not determined. A parallel, randomized, placebo-controlled trial. Tertiary level oncology center. 88 female patients with breast cancer were subjected to modified radi...

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Veröffentlicht in:Journal of clinical anesthesia 2020-12, Vol.67, p.110007-110007, Article 110007
Hauptverfasser: Hetta, Diab Fuad, Elgalaly, Nourhan Alaa, Hetta, Helal F., Fattah Mohammad, Montaser A.
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Elgalaly, Nourhan Alaa
Hetta, Helal F.
Fattah Mohammad, Montaser A.
description Duloxetine has been recently used as a part of multimodal analgesia in perioperative settings, yet the optimal dose of Duloxetine is not determined. A parallel, randomized, placebo-controlled trial. Tertiary level oncology center. 88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited. Participants 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. The 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. The 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 
doi_str_mv 10.1016/j.jclinane.2020.110007
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A parallel, randomized, placebo-controlled trial. Tertiary level oncology center. 88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited. Participants 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. The 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. The 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 &lt; 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. Preoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects. The trial was registered at Clinical Trials.gov with unique ID number; NCT03468348. •Duloxetine has been used as a part of multimodal analgesia in perioperative settings, yet the optimal dose is not determined.•Preoperative duloxetine reduces postoperative opioid consumption and decreases pain severity.•Preoperative duloxetine improves postoperative quality of recovery.•The optimal preoperative dose of duloxetine is 60 mg.</description><identifier>ISSN: 0952-8180</identifier><identifier>EISSN: 1873-4529</identifier><identifier>DOI: 10.1016/j.jclinane.2020.110007</identifier><identifier>PMID: 32847776</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acute pain ; Analgesics ; Anesthesia ; Blood pressure ; Breast cancer ; Drug dosages ; Duloxetine ; Fentanyl ; Mastectomy ; Medical personnel ; Modified radical mastectomy ; Morphine ; Pain ; Patients ; Questionnaires ; Recovery (Medical) ; Serotonin norepinephrine reuptake inhibitors ; Surgery</subject><ispartof>Journal of clinical anesthesia, 2020-12, Vol.67, p.110007-110007, Article 110007</ispartof><rights>2020 Elsevier Inc.</rights><rights>Copyright © 2020 Elsevier Inc. 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The 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 &lt; 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. Preoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects. 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A parallel, randomized, placebo-controlled trial. Tertiary level oncology center. 88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited. Participants 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. The 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. The 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 &lt; 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. Preoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects. The trial was registered at Clinical Trials.gov with unique ID number; NCT03468348. •Duloxetine has been used as a part of multimodal analgesia in perioperative settings, yet the optimal dose is not determined.•Preoperative duloxetine reduces postoperative opioid consumption and decreases pain severity.•Preoperative duloxetine improves postoperative quality of recovery.•The optimal preoperative dose of duloxetine is 60 mg.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>32847776</pmid><doi>10.1016/j.jclinane.2020.110007</doi><tpages>1</tpages></addata></record>
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subjects Acute pain
Analgesics
Anesthesia
Blood pressure
Breast cancer
Drug dosages
Duloxetine
Fentanyl
Mastectomy
Medical personnel
Modified radical mastectomy
Morphine
Pain
Patients
Questionnaires
Recovery (Medical)
Serotonin norepinephrine reuptake inhibitors
Surgery
title Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial
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