Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial
Abstract Background Mastectomies are commonly performed and strongly associated with chronic postsurgical pain (CPSP), more specifically termed postmastectomy pain syndrome (PMPS), with 25–60% of patients reporting pain 3 months after surgery. PMPS interferes with function, recovery, and compliance...
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07884-y |
| _version_ | 1797349697650688000 |
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| author | Jing Wang Lisa V. Doan Deborah Axelrod John Rotrosen Binhuan Wang Hyung G. Park Robert R. Edwards Michele Curatolo Carina Jackman Raven Perez NCATS Trial Innovation Network |
| author_facet | Jing Wang Lisa V. Doan Deborah Axelrod John Rotrosen Binhuan Wang Hyung G. Park Robert R. Edwards Michele Curatolo Carina Jackman Raven Perez NCATS Trial Innovation Network |
| author_sort | Jing Wang |
| collection | DOAJ |
| description | Abstract Background Mastectomies are commonly performed and strongly associated with chronic postsurgical pain (CPSP), more specifically termed postmastectomy pain syndrome (PMPS), with 25–60% of patients reporting pain 3 months after surgery. PMPS interferes with function, recovery, and compliance with adjuvant therapy. Importantly, it is associated with chronic opioid use, as a recent study showed that 1 in 10 patients continue to use opioids at least 3 months after curative surgery. The majority of PMPS patients are women, and, over the past 10 years, women have outpaced men in the rate of growth in opioid dependence. Standard perioperative multimodal analgesia is only modestly effective in prevention of CPSP. Thus, interventions to reduce CPSP and PMPS are urgently needed. Ketamine is well known to improve pain and reduce opioid use in the acute postoperative period. Additionally, ketamine has been shown to control mood in studies of anxiety and depression. By targeting acute pain and improving mood in the perioperative period, ketamine may be able to prevent the development of CPSP. Methods Ketamine analgesia for long-lasting pain relief after surgery (KALPAS) is a phase 3, multicenter, randomized, placebo-controlled, double-blind trial to study the effectiveness of ketamine in reducing PMPS. The study compares continuous perioperative ketamine infusion vs single-dose ketamine in the postanesthesia care unit vs placebo for reducing PMPS. Participants are followed for 1 year after surgery. The primary outcome is pain at the surgical site at 3 months after the index surgery as assessed with the Brief Pain Inventory-short form pain severity subscale. Discussion This project is part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, a nationwide effort to address the opioid public health crisis. This study can substantially impact perioperative pain management and can contribute significantly to combatting the opioid epidemic. Trial registration ClinicalTrials.gov NCT05037123. Registered on September 8, 2021. |
| first_indexed | 2024-03-08T12:34:09Z |
| format | Article |
| id | doaj.art-23269a0ba72c41c192bc8a63b9317953 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-08T12:34:09Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-23269a0ba72c41c192bc8a63b93179532024-01-21T12:34:01ZengBMCTrials1745-62152024-01-0125111710.1186/s13063-023-07884-yOptimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trialJing Wang0Lisa V. Doan1Deborah Axelrod2John Rotrosen3Binhuan Wang4Hyung G. Park5Robert R. Edwards6Michele Curatolo7Carina Jackman8Raven Perez9NCATS Trial Innovation NetworkDepartment of Anesthesiology, Perioperative Care, and Pain Medicine, NYU Grossman School of MedicineDepartment of Anesthesiology, Perioperative Care, and Pain Medicine, NYU Grossman School of MedicineDepartment of Surgery, NYU Grossman School of MedicineDepartment of Psychiatry, NYU Grossman School of MedicineDepartment of Population Health, NYU Grossman School of MedicineDepartment of Population Health, NYU Grossman School of MedicineDepartment of Anesthesia, Brigham and Women’s HospitalDepartment of Anesthesiology and Pain Medicine, University of WashingtonDepartment of Anesthesiology, University of UtahDepartment of Anesthesiology, Perioperative Care, and Pain Medicine, NYU Grossman School of MedicineAbstract Background Mastectomies are commonly performed and strongly associated with chronic postsurgical pain (CPSP), more specifically termed postmastectomy pain syndrome (PMPS), with 25–60% of patients reporting pain 3 months after surgery. PMPS interferes with function, recovery, and compliance with adjuvant therapy. Importantly, it is associated with chronic opioid use, as a recent study showed that 1 in 10 patients continue to use opioids at least 3 months after curative surgery. The majority of PMPS patients are women, and, over the past 10 years, women have outpaced men in the rate of growth in opioid dependence. Standard perioperative multimodal analgesia is only modestly effective in prevention of CPSP. Thus, interventions to reduce CPSP and PMPS are urgently needed. Ketamine is well known to improve pain and reduce opioid use in the acute postoperative period. Additionally, ketamine has been shown to control mood in studies of anxiety and depression. By targeting acute pain and improving mood in the perioperative period, ketamine may be able to prevent the development of CPSP. Methods Ketamine analgesia for long-lasting pain relief after surgery (KALPAS) is a phase 3, multicenter, randomized, placebo-controlled, double-blind trial to study the effectiveness of ketamine in reducing PMPS. The study compares continuous perioperative ketamine infusion vs single-dose ketamine in the postanesthesia care unit vs placebo for reducing PMPS. Participants are followed for 1 year after surgery. The primary outcome is pain at the surgical site at 3 months after the index surgery as assessed with the Brief Pain Inventory-short form pain severity subscale. Discussion This project is part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, a nationwide effort to address the opioid public health crisis. This study can substantially impact perioperative pain management and can contribute significantly to combatting the opioid epidemic. Trial registration ClinicalTrials.gov NCT05037123. Registered on September 8, 2021.https://doi.org/10.1186/s13063-023-07884-yPostoperative painChronic postsurgical painPostmastectomy pain syndromeKetamineNon-opioid |
| spellingShingle | Jing Wang Lisa V. Doan Deborah Axelrod John Rotrosen Binhuan Wang Hyung G. Park Robert R. Edwards Michele Curatolo Carina Jackman Raven Perez NCATS Trial Innovation Network Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial Trials Postoperative pain Chronic postsurgical pain Postmastectomy pain syndrome Ketamine Non-opioid |
| title | Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial |
| title_full | Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial |
| title_fullStr | Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial |
| title_full_unstemmed | Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial |
| title_short | Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial |
| title_sort | optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication study protocol for the kalpas multicenter randomized controlled trial |
| topic | Postoperative pain Chronic postsurgical pain Postmastectomy pain syndrome Ketamine Non-opioid |
| url | https://doi.org/10.1186/s13063-023-07884-y |
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