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The Use of Electronic Consent (eConsent) Within the Ketamine for Long-Lasting Pain Relief After Surgery (KALPAS) Multicenter Trial

Doan, Lisa V; Burr, Jeri; Perez, Raven; Martinez, Hamleini; Cuevas, Randy; Watt, Kevin; Wang, Jing
BACKGROUND/UNASSIGNED:The informed consent process has traditionally taken place in person. The introduction of electronic consent (eConsent) has made remote consenting processes possible. Use of eConsent has increased since the COVID-19 pandemic. It has streamlined the process of consenting patients and has been shown to benefit the research study team and participants. ECONSENT IN THE KETAMINE ANALGESIA FOR LONG-LASTING PAIN RELIEF AFTER SURGERY KALPAS STUDY/UNASSIGNED:The KALPAS study is a multicenter, double-blind, randomized controlled study investigating the effectiveness of ketamine in reducing chronic post-mastectomy pain in women undergoing mastectomy for oncologic indication. The study uses a two-part consent form consisting of a master consent with information applicable to all sites and site-specific information. All potential participants receive the full two-part consent form for review. When signing the eConsent, however, all potential participants are provided with a concise summary of the informed consent document, an approach not widely used by multicenter studies. eConsent has been noted to be beneficial to research staff when trying to gather informed consent from participants who live far away from the hospital, want to include their family and friends, and for researchers who can approach patients outside of their clinical appointments. CONCLUSION/UNASSIGNED:The ability to consent patients remotely has allowed for a flexible workflow within sites and a more patient-centric process that focuses on including loved ones in the discussion and scheduling time to speak to a principal investigator. Demand for eConsent will likely continue in the post-COVID era, and use of a concise summary can allow for a more efficient consenting process.
PMCID:11808973
PMID: 39931425
ISSN: 1178-7090
CID: 5793292

Application of the Uniform Data Set version 3 tele-adapted test battery (T-cog) for remote cognitive assessment preoperatively in older adults

Rockholt, Mika M; Wu, Rachel R; Zhu, Elaine; Perez, Raven; Martinez, Hamleini; Hui, Jessica J; Commeh, Ekow B; Denoon, Romario B; Bruno, Gabrielle; Saba, Braden V; Waren, Daniel; O'Brien, Courtney; Aggarwal, Vinay K; Rozell, Joshua C; Furgiuele, David; Macaulay, William; Schwarzkopf, Ran; Schulze, Evan T; Osorio, Ricardo S; Doan, Lisa V; Wang, Jing
INTRODUCTION/UNASSIGNED:Older adults undergoing surgery are at risk of postoperative neurocognitive disorders, prompting the need for preoperative cognitive screening in this population. Traditionally, cognitive screening has been conducted in-person using brief assessment tools such as the Montreal Cognitive Assessment (MoCA) or the Mini-Mental State Examination (MMSE). More comprehensive test batteries, such as the Uniform Data Set (UDS) Neuropsychological Battery, and its remote testing version, the Uniform Data Set version 3 tele-adapted test battery (UDS v3.0 T-cog), have been developed to assess cognitive decline in normal aging and disease conditions, but have not been applied in the perioperative setting. METHODS/UNASSIGNED:We assessed the feasibility of using this remote UDS v3.0 T-cog battery for preoperative cognitive assessment in 81 older adults 65+ scheduled for lower extremity joint replacement surgery. RESULTS/UNASSIGNED:Our results indicate that the UDS v3.0 T-cog achieves 99% completion rates and demonstrates high patient satisfaction. Further, we found 28% of subjects were cognitively impaired in this patient cohort. DISCUSSION/UNASSIGNED:These findings suggest that the UDS v3.0 T-cog is a feasible tool for assessing cognitive function in the older adult perioperative population. To our knowledge, this is the first study to apply this comprehensive remote test battery in the preoperative setting.
PMCID:11782117
PMID: 39897457
ISSN: 1663-4365
CID: 5783672

Fluoroscopy-Guided Transgluteal Pudendal Nerve Block for Pudendal Neuralgia: A Retrospective Case Series

Levin, Danielle; Van Florcke, Daniel; Schmitt, Monika; Kendall, Lucinda Kurzava; Patel, Alopi; Doan, Lisa V; Kirpekar, Meera
PMCID:11084891
PMID: 38731163
ISSN: 2077-0383
CID: 5734092

Clinical pain management: Current practice and recent innovations in research

Wang, Jing; Doan, Lisa V
Chronic pain affects one in five adults. It is not only a major cause of disability for individual patients but also a driver of costs for entire healthcare systems. Treatment of pain remains a challenge, and the use of opioids has further led to a concurrent opioid epidemic. In this review, we discuss current standard treatment options for chronic pain, including pharmacological, behavioral, and interventional treatments. In addition, we review ongoing research in different areas that will potentially unlock new therapies.
PMID: 39383871
ISSN: 2666-3791
CID: 5706162

Pain Management Treatments and Opioid Use Disorder Risk in Medicaid Patients

Rudolph, Kara E; Williams, Nicholas T; Diaz, Ivan; Forrest, Sarah; Hoffman, Katherine L; Samples, Hillary; Olfson, Mark; Doan, Lisa; Cerda, Magdalena; Ross, Rachael K
INTRODUCTION/BACKGROUND:People with chronic pain are at increased risk of opioid misuse. Less is known about the unique risk conferred by each pain management treatment, as treatments are typically implemented together, confounding their independent effects. This study estimated the extent to which pain management treatments were associated with risk of opioid use disorder (OUD) for those with chronic pain, controlling for baseline demographic and clinical confounding variables and holding other pain management treatments at their observed levels. METHODS:Data were analyzed in 2024 from 2 chronic pain subgroups within a cohort of non-pregnant Medicaid patients aged 35-64 years, 2016-2019, from 25 states: those with (1) chronic pain and physical disability (CPPD) (N=6,133) or (2) chronic pain without disability (CP) (N=67,438). Nine pain management treatments were considered: prescription opioid (1) dose and (2) duration; (3) number of opioid prescribers; opioid co-prescription with (4) benzo- diazepines, (5) muscle relaxants, and (6) gabapentinoids; (7) nonopioid pain prescription, (8) physical therapy, and (9) other pain treatment modality. The outcome was OUD risk. RESULTS:Having opioids co-prescribed with gabapentin or benzodiazepine was statistically significantly associated with a 37-45% increased OUD risk for the CP subgroup. Opioid dose and duration also were significantly associated with increased OUD risk in this subgroup. Physical therapy was significantly associated with an 18% decreased risk of OUD in the CP subgroup. DISCUSSION/CONCLUSIONS:Coprescription of opioids with either gabapentin or benzodiazepines may substantially increase OUD risk. More positively, physical therapy may be a relatively accessible and safe pain management strategy.
PMID: 39025248
ISSN: 1873-2607
CID: 5695952

Prevention of Post-Mastectomy Pain Syndrome: A Review of Recent Literature on Perioperative Interventions

Wu, Rachel R; Katz, Simon; Wang, Jing; Doan, Lisa V
PURPOSE OF REVIEW/OBJECTIVE:Up to 60% of breast cancer patients continue to experience pain three months or more after surgery, with 15 to 25% reporting moderate to severe pain. Post-mastectomy pain syndrome (PMPS) places a high burden on patients. We reviewed recent studies on perioperative interventions to prevent PMPS incidence and severity. RECENT FINDINGS/RESULTS:Recent studies on pharmacologic and regional anesthetic interventions were reviewed. Only nine of the twenty-three studies included reported a significant improvement in PMPS incidence and/or severity, sometimes with mixed results for similar interventions. Evidence for prevention of PMPS is mixed. Further investigation of impact of variations in dosing is warranted. In addition, promising newer interventions for prevention of PMPS such as cryoneurolysis of intercostal nerves and stellate ganglion block need confirmatory studies.
PMID: 38814502
ISSN: 1534-6269
CID: 5663762

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

Wang, Jing; Doan, Lisa V; Axelrod, Deborah; Rotrosen, John; Wang, Binhuan; Park, Hyung G; Edwards, Robert R; Curatolo, Michele; Jackman, Carina; Perez, Raven; ,
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/CONCLUSIONS: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/BACKGROUND:ClinicalTrials.gov NCT05037123. Registered on September 8, 2021.
PMCID:10797799
PMID: 38243266
ISSN: 1745-6215
CID: 5624462

An Overview of Cannabidiol

Sideris, Alexandra; Doan, Lisa V
Cannabidiol (CBD) is one of the most interesting constituents of cannabis, garnering significant attention in the medical community in recent years due to its proven benefit for reducing refractory seizures in pediatric patients. Recent legislative changes in the United States have made CBD readily available to the general public, with up to 14% of adults in the United States having tried it in 2019. CBD is used to manage a myriad of symptoms, including anxiety, pain, and sleep disturbances, although rigorous evidence for these indications is lacking. A significant advantage of CBD over the other more well-known cannabinoid delta-9-tetrahydroncannabinol (THC) is that CBD does not produce a "high." As patients increasingly self-report its use to manage their medical conditions, and as the opioid epidemic continues to drive the quest for alternative pain management approaches, the aims of this narrative review are to provide a broad overview of the discovery, pharmacology, and molecular targets of CBD, its purported and approved neurologic indications, evidence for its analgesic potential, regulatory implications for patients and providers, and future research needs.
PMID: 38108806
ISSN: 1526-7598
CID: 5612642

Multiorganizational consensus to define guiding principles for perioperative pain management in patients with chronic pain, preoperative opioid tolerance, or substance use disorder

Dickerson, David M; Mariano, Edward R; Szokol, Joseph W; Harned, Michael; Clark, Randall M; Mueller, Jeffrey T; Shilling, Ashley M; Udoji, Mercy A; Mukkamala, S Bobby; Doan, Lisa; Wyatt, Karla E K; Schwalb, Jason M; Elkassabany, Nabil M; Eloy, Jean D; Beck, Stacy L; Wiechmann, Lisa; Chiao, Franklin; Halle, Steven G; Krishnan, Deepak G; Cramer, John D; Ali Sakr Esa, Wael; Muse, Iyabo O; Baratta, Jaime; Rosenquist, Richard; Gulur, Padma; Shah, Shalini; Kohan, Lynn; Robles, Jennifer; Schwenk, Eric S; Allen, Brian F S; Yang, Stephen; Hadeed, Josef G; Schwartz, Gary; Englesbe, Michael J; Sprintz, Michael; Urish, Kenneth L; Walton, Ashley; Keith, Lauren; Buvanendran, Asokumar
Significant knowledge gaps exist in the perioperative pain management of patients with a history of chronic pain, substance use disorder, and/or opioid tolerance as highlighted in the US Health and Human Services Pain Management Best Practices Inter-Agency Task Force 2019 report. The report emphasized the challenges of caring for these populations and the need for multidisciplinary care and a comprehensive approach. Such care requires stakeholder alignment across multiple specialties and care settings. With the intention of codifying this alignment into a reliable and efficient processes, a consortium of 15 professional healthcare societies was convened in a year-long modified Delphi consensus process and summit. This process produced seven guiding principles for the perioperative care of patients with chronic pain, substance use disorder, and/or preoperative opioid tolerance. These principles provide a framework and direction for future improvement in the optimization and care of 'complex' patients as they undergo surgical procedures.
PMID: 37185214
ISSN: 1532-8651
CID: 5544112

Pain associated with breast cancer: etiologies and therapies

Doan, Lisa V; Yoon, Jenny; Chun, Jeana; Perez, Raven; Wang, Jing
Pain associated with breast cancer is a prevalent problem that negatively affects quality of life. Breast cancer pain is not limited to the disease course itself but is also induced by current therapeutic strategies. This, combined with the increasing number of patients living with breast cancer, make pain management for breast cancer patients an increasingly important area of research. This narrative review presents a summary of pain associated with breast cancer, including pain related to the cancer disease process itself and pain associated with current therapeutic modalities including radiation, chemotherapy, immunotherapy, and surgery. Current pain management techniques, their limitations, and novel analgesic strategies are also discussed.
PMCID:10750403
PMID: 38148788
ISSN: 2673-561x
CID: 5623542