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Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

BACKGROUND: Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions a...

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Autores principales: Gazendam, Aaron, Ekhtiari, Seper, Horner, Nolan S., Simunovic, Nicole, Duong, Andrew, de Sa, Darren, Peterson, Devin, Denkers, Matthew, Khanna, Vickas, Adili, Anthony, Moro, Jaydeep, Khan, Moin, Ayeni, Olufemi R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141233/
https://www.ncbi.nlm.nih.gov/pubmed/34022863
http://dx.doi.org/10.1186/s12891-021-04354-x
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author Gazendam, Aaron
Ekhtiari, Seper
Horner, Nolan S.
Simunovic, Nicole
Duong, Andrew
de Sa, Darren
Peterson, Devin
Denkers, Matthew
Khanna, Vickas
Adili, Anthony
Moro, Jaydeep
Khan, Moin
Ayeni, Olufemi R.
author_facet Gazendam, Aaron
Ekhtiari, Seper
Horner, Nolan S.
Simunovic, Nicole
Duong, Andrew
de Sa, Darren
Peterson, Devin
Denkers, Matthew
Khanna, Vickas
Adili, Anthony
Moro, Jaydeep
Khan, Moin
Ayeni, Olufemi R.
author_sort Gazendam, Aaron
collection PubMed
description BACKGROUND: Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. METHODS: This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. DISCUSSION: The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. TRIAL REGISTRATION: The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-021-04354-x.
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spelling pubmed-81412332021-05-25 Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery Gazendam, Aaron Ekhtiari, Seper Horner, Nolan S. Simunovic, Nicole Duong, Andrew de Sa, Darren Peterson, Devin Denkers, Matthew Khanna, Vickas Adili, Anthony Moro, Jaydeep Khan, Moin Ayeni, Olufemi R. BMC Musculoskelet Disord Study Protocol BACKGROUND: Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. METHODS: This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. DISCUSSION: The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. TRIAL REGISTRATION: The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-021-04354-x. BioMed Central 2021-05-22 /pmc/articles/PMC8141233/ /pubmed/34022863 http://dx.doi.org/10.1186/s12891-021-04354-x Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/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/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Gazendam, Aaron
Ekhtiari, Seper
Horner, Nolan S.
Simunovic, Nicole
Duong, Andrew
de Sa, Darren
Peterson, Devin
Denkers, Matthew
Khanna, Vickas
Adili, Anthony
Moro, Jaydeep
Khan, Moin
Ayeni, Olufemi R.
Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery
title Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery
title_full Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery
title_fullStr Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery
title_full_unstemmed Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery
title_short Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery
title_sort protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141233/
https://www.ncbi.nlm.nih.gov/pubmed/34022863
http://dx.doi.org/10.1186/s12891-021-04354-x
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