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
Abstract 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 Prescri...
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| Format: | Article |
| Language: | English |
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BMC
2021-05-01
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| Series: | BMC Musculoskeletal Disorders |
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| Online Access: | https://doi.org/10.1186/s12891-021-04354-x |
| _version_ | 1818597478273908736 |
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| author | Aaron Gazendam Seper Ekhtiari Nolan S. Horner Nicole Simunovic Andrew Duong Darren de Sa Devin Peterson Matthew Denkers Vickas Khanna Anthony Adili Jaydeep Moro Moin Khan Olufemi R. Ayeni The NO PAin Investigators |
| author_facet | Aaron Gazendam Seper Ekhtiari Nolan S. Horner Nicole Simunovic Andrew Duong Darren de Sa Devin Peterson Matthew Denkers Vickas Khanna Anthony Adili Jaydeep Moro Moin Khan Olufemi R. Ayeni The NO PAin Investigators |
| author_sort | Aaron Gazendam |
| collection | DOAJ |
| description | Abstract 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 ). |
| first_indexed | 2024-12-16T11:48:26Z |
| format | Article |
| id | doaj.art-fdb628a2772a413a9689ecaa8b721d42 |
| institution | Directory Open Access Journal |
| issn | 1471-2474 |
| language | English |
| last_indexed | 2024-12-16T11:48:26Z |
| publishDate | 2021-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Musculoskeletal Disorders |
| spelling | doaj.art-fdb628a2772a413a9689ecaa8b721d422022-12-21T22:32:46ZengBMCBMC Musculoskeletal Disorders1471-24742021-05-012211910.1186/s12891-021-04354-xProtocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgeryAaron Gazendam0Seper Ekhtiari1Nolan S. Horner2Nicole Simunovic3Andrew Duong4Darren de Sa5Devin Peterson6Matthew Denkers7Vickas Khanna8Anthony Adili9Jaydeep Moro10Moin Khan11Olufemi R. Ayeni12The NO PAin InvestigatorsDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityDepartment of Surgery, Division of Orthopaedic Surgery, McMaster UniversityAbstract 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 ).https://doi.org/10.1186/s12891-021-04354-xArthroscopyOpioid sparingNonopioidRandomized controlled trial |
| spellingShingle | Aaron Gazendam Seper Ekhtiari Nolan S. Horner Nicole Simunovic Andrew Duong Darren de Sa Devin Peterson Matthew Denkers Vickas Khanna Anthony Adili Jaydeep Moro Moin Khan Olufemi R. Ayeni The NO PAin Investigators 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 BMC Musculoskeletal Disorders Arthroscopy Opioid sparing Nonopioid Randomized controlled trial |
| 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 | Arthroscopy Opioid sparing Nonopioid Randomized controlled trial |
| url | https://doi.org/10.1186/s12891-021-04354-x |
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