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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creator | Hetta, Diab Fuad 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 |
format | Article |
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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 < 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. All rights reserved.</rights><rights>2020. Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c462t-6e48922dae88073e7c780176f62440dce24f7938965faa9b6965f108068a79a63</citedby><cites>FETCH-LOGICAL-c462t-6e48922dae88073e7c780176f62440dce24f7938965faa9b6965f108068a79a63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0952818020310254$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32847776$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hetta, Diab Fuad</creatorcontrib><creatorcontrib>Elgalaly, Nourhan Alaa</creatorcontrib><creatorcontrib>Hetta, Helal F.</creatorcontrib><creatorcontrib>Fattah Mohammad, Montaser A.</creatorcontrib><title>Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial</title><title>Journal of clinical anesthesia</title><addtitle>J Clin Anesth</addtitle><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 < 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><subject>Acute pain</subject><subject>Analgesics</subject><subject>Anesthesia</subject><subject>Blood pressure</subject><subject>Breast cancer</subject><subject>Drug dosages</subject><subject>Duloxetine</subject><subject>Fentanyl</subject><subject>Mastectomy</subject><subject>Medical personnel</subject><subject>Modified radical mastectomy</subject><subject>Morphine</subject><subject>Pain</subject><subject>Patients</subject><subject>Questionnaires</subject><subject>Recovery (Medical)</subject><subject>Serotonin norepinephrine reuptake inhibitors</subject><subject>Surgery</subject><issn>0952-8180</issn><issn>1873-4529</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkc-OFCEQxonRuOPqK2xIvHjpEWgGaE9u1r_JJnrQM2GhekKHhlmgNzs-jw8qndn14MVTVap-9RXUh9AFJVtKqHg7bScbfDQRtoywVqSEEPkEbaiSfcd3bHiKNmTYsU5RRc7Qi1KmRrQGfY7Oeqa4lFJs0O_vGdIBsqn-DvCHJaR7qD4Crgn7-ZBTqxq7VMAH4yM20eHbxQRfjziNOINtQD7i1jo0CYi14CU6yPvk4x7PyfnRg8PZOG9NwLMpFWxN8_EdvsQuFeiyifuVbdGl2f9qtE2x5hRCS2v2JrxEz0YTCrx6iOfo56ePP66-dNffPn-9urzuLBesdgK4GhhzBpQisgdppSJUilEwzomzwPgoh14NYjcaM9yINaFEEaGMHIzoz9Gbk2779-0CperZFwshtDOnpWjGe6k4o1w29PU_6JSWHNvrGiXojrNBrILiRNmcSskw6kP2s8lHTYlefdSTfvRRrz7qk49t8OJBfrmZwf0dezSuAe9PALR73HnIuth2fgvON1Oqdsn_b8cfUeK0gA</recordid><startdate>202012</startdate><enddate>202012</enddate><creator>Hetta, Diab Fuad</creator><creator>Elgalaly, Nourhan Alaa</creator><creator>Hetta, Helal F.</creator><creator>Fattah Mohammad, Montaser A.</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>202012</creationdate><title>Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial</title><author>Hetta, Diab Fuad ; 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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 < 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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