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Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study

PURPOSE: Effectiveness of sufentanil sublingual tablet system (SSTS) compared to oral oxycodone in the management of postoperative pain after total knee arthroplasty (TKA) within an enhanced recovery after surgery (ERAS) protocol. METHODS: This pragmatic, parallel, open label, randomized controlled,...

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Autores principales: Noel, Emmanuel, Miglionico, Luca, Leclercq, Mickael, Jennart, Harold, Fils, Jean-François, Van Rompaey, Nicolas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7679427/
https://www.ncbi.nlm.nih.gov/pubmed/33216238
http://dx.doi.org/10.1186/s40634-020-00306-x
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author Noel, Emmanuel
Miglionico, Luca
Leclercq, Mickael
Jennart, Harold
Fils, Jean-François
Van Rompaey, Nicolas
author_facet Noel, Emmanuel
Miglionico, Luca
Leclercq, Mickael
Jennart, Harold
Fils, Jean-François
Van Rompaey, Nicolas
author_sort Noel, Emmanuel
collection PubMed
description PURPOSE: Effectiveness of sufentanil sublingual tablet system (SSTS) compared to oral oxycodone in the management of postoperative pain after total knee arthroplasty (TKA) within an enhanced recovery after surgery (ERAS) protocol. METHODS: This pragmatic, parallel, open label, randomized controlled, trial enrolled 72 adult patients scheduled for TKA under spinal anesthesia following ERAS pathway. In addition to multimodal analgesia, patients received SSTS 15 mcg (SSTS group) or oral oxycodone extended release 10 mg twice daily and oral oxycodone immediate-release 5 mg up to four times daily on demand (Oxy group) to control pain during 48 h postoperatively. The primary endpoint was pain measured using a numeric rating scale at 24 h postoperatively. Time to first mobilization, side effects and patient satisfaction were also recorded. RESULTS: Median pain score at 24 h at rest was 3 [2–4] for Oxy group vs 2 [1.75–3] for SSTS group (p = 0.272) whereas median pain score on movement was 4 [3–6] vs 3 [2–5] respectively (p = 0.059). No difference in time to first mobilization was found between the two groups. The method of pain control was judged good/excellent for 83.9% of patients in the SSTS group compared with 52.9% in the Oxy group (p = 0.007). The incidence of nausea was 33% in SSTS group and 9% in Oxy group (p = 0.181). CONCLUSIONS: In complement to ERAS multimodal analgesia, sublingual sufentanil 15 mcg tablet system did not show clinically significant pain improvement compared to oral oxycodone after total knee arthroplasty. TRIAL REGISTRATION: Clinical Trials: NCT04448457; retrospectively registered on June 24, 2020. https://clinicaltrials.gov/ct2/show/NCT04448457?cond=sublingual+sufentanil&cntry=BE&draw=2&rank=3
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spelling pubmed-76794272020-11-23 Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study Noel, Emmanuel Miglionico, Luca Leclercq, Mickael Jennart, Harold Fils, Jean-François Van Rompaey, Nicolas J Exp Orthop Original Paper PURPOSE: Effectiveness of sufentanil sublingual tablet system (SSTS) compared to oral oxycodone in the management of postoperative pain after total knee arthroplasty (TKA) within an enhanced recovery after surgery (ERAS) protocol. METHODS: This pragmatic, parallel, open label, randomized controlled, trial enrolled 72 adult patients scheduled for TKA under spinal anesthesia following ERAS pathway. In addition to multimodal analgesia, patients received SSTS 15 mcg (SSTS group) or oral oxycodone extended release 10 mg twice daily and oral oxycodone immediate-release 5 mg up to four times daily on demand (Oxy group) to control pain during 48 h postoperatively. The primary endpoint was pain measured using a numeric rating scale at 24 h postoperatively. Time to first mobilization, side effects and patient satisfaction were also recorded. RESULTS: Median pain score at 24 h at rest was 3 [2–4] for Oxy group vs 2 [1.75–3] for SSTS group (p = 0.272) whereas median pain score on movement was 4 [3–6] vs 3 [2–5] respectively (p = 0.059). No difference in time to first mobilization was found between the two groups. The method of pain control was judged good/excellent for 83.9% of patients in the SSTS group compared with 52.9% in the Oxy group (p = 0.007). The incidence of nausea was 33% in SSTS group and 9% in Oxy group (p = 0.181). CONCLUSIONS: In complement to ERAS multimodal analgesia, sublingual sufentanil 15 mcg tablet system did not show clinically significant pain improvement compared to oral oxycodone after total knee arthroplasty. TRIAL REGISTRATION: Clinical Trials: NCT04448457; retrospectively registered on June 24, 2020. https://clinicaltrials.gov/ct2/show/NCT04448457?cond=sublingual+sufentanil&cntry=BE&draw=2&rank=3 Springer Berlin Heidelberg 2020-11-20 /pmc/articles/PMC7679427/ /pubmed/33216238 http://dx.doi.org/10.1186/s40634-020-00306-x Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Original Paper
Noel, Emmanuel
Miglionico, Luca
Leclercq, Mickael
Jennart, Harold
Fils, Jean-François
Van Rompaey, Nicolas
Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study
title Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study
title_full Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study
title_fullStr Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study
title_full_unstemmed Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study
title_short Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study
title_sort sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7679427/
https://www.ncbi.nlm.nih.gov/pubmed/33216238
http://dx.doi.org/10.1186/s40634-020-00306-x
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