Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial

Introduction: Open-label placebos have been proposed as way of using long recognized analgesic placebo effects in an ethical manner. Recent evidence shows efficacy of open-label placebos for clinical conditions, but there is need for more research on open-label placebos in acute pain. In the treatme...

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Autores principales:	Dilan Sezer, Matthijs de Leeuw, Cordula Netzer, Markus Dieterle, Andrea Meyer, Sarah Buergler, Cosima Locher, Wilhelm Ruppen, Jens Gaab, Tobias Schneider
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	open-label placebo acute postoperative pain opioids postoperative analgesia placebo analgesia lumbar interbody fusion Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/f63fce32e34740b9bd3962ad2897def8
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spelling	oai:doaj.org-article:f63fce32e34740b9bd3962ad2897def82021-11-05T10:21:51ZOpen-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial2296-858X10.3389/fmed.2021.687398https://doaj.org/article/f63fce32e34740b9bd3962ad2897def82021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fmed.2021.687398/fullhttps://doaj.org/toc/2296-858XIntroduction: Open-label placebos have been proposed as way of using long recognized analgesic placebo effects in an ethical manner. Recent evidence shows efficacy of open-label placebos for clinical conditions, but there is need for more research on open-label placebos in acute pain. In the treatment of acute postoperative pain, minimization of opioid related side effects remains one of the key challenges. Therefore, this study aims at investigating the potential of adding unconditioned open-label placebos to treatment as usual as a means of reducing opioid consumption and its related side effects in patients with acute postoperative pain.Methods and Analysis: This is the protocol of an ongoing single site randomized controlled trial. The first patient was enrolled in May 2020. In total, 70 patients suffering from acute postoperative pain following dorsal lumbar interbody fusion are randomized to either a treatment as usual group or an experimental intervention group. The treatment as usual group consists of participants receiving a patient-controlled morphine pump. On day 1 and 2 post-surgery, patients in the intervention group receive, in addition to treatment as usual, two open-label placebo injections per day along with an evidence-based treatment rationale explaining the mechanisms of placebos. The primary outcome is measured by means of self-administered morphine during day 1 and 2 post-surgery. Several other outcome measures including pain intensity and adverse events as well as potential predictors of placebo response are assessed. Analysis of covariance will be used to answer the primary research question and additional statistical techniques such as generalized linear mixed models will be applied to model the temporal course of morphine consumption.Discussion: This study will provide valuable insights into the efficacy of open-label placebos in acute pain and will potentially constitute an important step toward the implementation of open-label placebos in the clinical management of acute postoperative pain. In addition, it will shed light on a cost-efficient and patient-centered strategy to reduce opioid consumption and its related side effects, without any loss in pain management efficacy.Ethics and Dissemination: The “Ethikkommission Nordwest- und Zentralschweiz” (BASEC2020-00099) approved the study protocol. Results of the analysis will be submitted for publication in a peer-reviewed journal.Clinical Trial Registration: The study is registered at ClinicalTrials.gov (NCT04339023) and is listed in the Swiss national registry at kofam.ch (SNCTP000003720).Dilan SezerMatthijs de LeeuwCordula NetzerMarkus DieterleAndrea MeyerSarah BuerglerCosima LocherCosima LocherWilhelm RuppenJens GaabTobias SchneiderFrontiers Media S.A.articleopen-label placeboacute postoperative painopioidspostoperative analgesiaplacebo analgesialumbar interbody fusionMedicine (General)R5-920ENFrontiers in Medicine, Vol 8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	open-label placebo acute postoperative pain opioids postoperative analgesia placebo analgesia lumbar interbody fusion Medicine (General) R5-920
spellingShingle	open-label placebo acute postoperative pain opioids postoperative analgesia placebo analgesia lumbar interbody fusion Medicine (General) R5-920 Dilan Sezer Matthijs de Leeuw Cordula Netzer Markus Dieterle Andrea Meyer Sarah Buergler Cosima Locher Cosima Locher Wilhelm Ruppen Jens Gaab Tobias Schneider Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial
description	Introduction: Open-label placebos have been proposed as way of using long recognized analgesic placebo effects in an ethical manner. Recent evidence shows efficacy of open-label placebos for clinical conditions, but there is need for more research on open-label placebos in acute pain. In the treatment of acute postoperative pain, minimization of opioid related side effects remains one of the key challenges. Therefore, this study aims at investigating the potential of adding unconditioned open-label placebos to treatment as usual as a means of reducing opioid consumption and its related side effects in patients with acute postoperative pain.Methods and Analysis: This is the protocol of an ongoing single site randomized controlled trial. The first patient was enrolled in May 2020. In total, 70 patients suffering from acute postoperative pain following dorsal lumbar interbody fusion are randomized to either a treatment as usual group or an experimental intervention group. The treatment as usual group consists of participants receiving a patient-controlled morphine pump. On day 1 and 2 post-surgery, patients in the intervention group receive, in addition to treatment as usual, two open-label placebo injections per day along with an evidence-based treatment rationale explaining the mechanisms of placebos. The primary outcome is measured by means of self-administered morphine during day 1 and 2 post-surgery. Several other outcome measures including pain intensity and adverse events as well as potential predictors of placebo response are assessed. Analysis of covariance will be used to answer the primary research question and additional statistical techniques such as generalized linear mixed models will be applied to model the temporal course of morphine consumption.Discussion: This study will provide valuable insights into the efficacy of open-label placebos in acute pain and will potentially constitute an important step toward the implementation of open-label placebos in the clinical management of acute postoperative pain. In addition, it will shed light on a cost-efficient and patient-centered strategy to reduce opioid consumption and its related side effects, without any loss in pain management efficacy.Ethics and Dissemination: The “Ethikkommission Nordwest- und Zentralschweiz” (BASEC2020-00099) approved the study protocol. Results of the analysis will be submitted for publication in a peer-reviewed journal.Clinical Trial Registration: The study is registered at ClinicalTrials.gov (NCT04339023) and is listed in the Swiss national registry at kofam.ch (SNCTP000003720).
format	article
author	Dilan Sezer Matthijs de Leeuw Cordula Netzer Markus Dieterle Andrea Meyer Sarah Buergler Cosima Locher Cosima Locher Wilhelm Ruppen Jens Gaab Tobias Schneider
author_facet	Dilan Sezer Matthijs de Leeuw Cordula Netzer Markus Dieterle Andrea Meyer Sarah Buergler Cosima Locher Cosima Locher Wilhelm Ruppen Jens Gaab Tobias Schneider
author_sort	Dilan Sezer
title	Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial
title_short	Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial
title_full	Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial
title_fullStr	Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial
title_full_unstemmed	Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial
title_sort	open-label placebo treatment for acute postoperative pain (olp-pop study): study protocol of a randomized controlled trial
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/f63fce32e34740b9bd3962ad2897def8
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Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial

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