Background: Concerns about low accrual have long been a standard part of the discourse on cancer clinical trials, reaching even as far as the news media. Indeed, so many trials are closed before completing accrual that a cottage industry has recently developed creating statistical models to predict trial failure. We previously proposed four methodologic fixes for the current crisis in clinical trials: (1) dramatically reducing the number of eligibility criteria, (2) using data routinely collected in clinical practice for trial endpoints; then lowering barriers to accrual by (3) cluster randomization or (4) staged consent.
View Article and Find Full Text PDFBackground: Performing large randomized trials in anesthesiology is often challenging and costly. The clinically integrated randomized trial is characterized by simplified logistics embedded into routine clinical practice, enabling ease and efficiency of recruitment, offering an opportunity for clinicians to conduct large, high-quality randomized trials under low cost. Our aims were to (1) demonstrate the feasibility of the clinically integrated trial design in a high-volume anesthesiology practice and (2) assess whether trial quality improvement interventions led to more balanced accrual among study arms and improved trial compliance over time.
View Article and Find Full Text PDFBackground: There is limited evidence that regional anesthesia reduces pain in patients undergoing mastectomy with immediate implant-based reconstruction. We sought to determine whether regional blocks reduce opioid consumption and improve post-discharge patient-reported pain in this population.
Methods: We retrospectively reviewed patients who underwent bilateral mastectomy with immediate implant-based reconstruction with and without a regional block.
Background And Objectives: We investigated whether age, body mass index (BMI), and tissue expander placement were related to postoperative opioid requirement for patients undergoing therapeutic versus prophylactic breast surgery.
Methods: Postoperative opioid consumption was evaluated for patients who underwent bilateral mastectomy with immediate implant-based reconstruction at a freestanding ambulatory cancer surgery center between 2016 and 2021. Ordinal regression tested whether surgical indication was associated with increased postoperative opioid requirements after adjusting for age, BMI, and tissue expander placement.
Background: The paravertebral block (PVB) is an adjunctive perioperative pain control method for patients undergoing breast reconstruction that may improve perioperative pain control and reduce narcotic use. This study determined the efficacy of preoperative PVBs for perioperative pain management in patients undergoing tissue expander breast reconstruction.
Methods: A retrospective review was performed of patients who underwent tissue expander breast reconstruction from December of 2017 to September of 2019.
Ambulatory surgery centers (ASC) serve an important role for hospital systems of increasing operating capacity and offloading patient volume. When seeking to perform more complex cancer surgeries at an ASC, a systematic approach with care pathways can yield success by facilitating quick recovery for patients and reducing complication rates. End-to-end patient engagement is a key component of patient-centered care at the Josie Robertson Surgery Center and begins the moment the decision to have surgery is made and extends to the postdischarge period to track recovery.
View Article and Find Full Text PDFIntroduction: Acute postoperative pain affects time to opioid cessation and quality of life, and is associated with chronic pain. Effective screening tools are needed to identify patients at increased risk of experiencing more severe acute postoperative pain, and who may benefit from multimodal analgesia and early pain management referral. In this study, we develop a nomogram to preoperatively identify patients at high risk of moderate-severe pain following mastectomy.
View Article and Find Full Text PDFBackground: We describe the implementation of enhanced recovery after surgery (ERAS) programs designed to minimize postoperative nausea and vomiting (PONV) and pain and reduce opioid use in patients undergoing selected procedures at an ambulatory cancer surgery center. Key components of the ERAS included preoperative patient education regarding the postoperative course, liberal preoperative hydration, standardized PONV prophylaxis, appropriate intraoperative fluid management, and multimodal analgesia at all stages.
Methods: We retrospectively reviewed data on patients who underwent mastectomy with or without immediate reconstruction, minimally invasive hysterectomy, thyroidectomy, or minimally invasive prostatectomy from the opening of our institution on January 2016 to December 2018.
Background: Although ketorolac is an effective adjunct for managing pain in the perioperative period, it is associated with a risk of postoperative bleeding. This study retrospectively investigated the association between ketorolac use and both reoperation and postoperative opioid use among mastectomy patients.
Methods: The study identified all women undergoing mastectomy (unilaterally or bilaterally) at our ambulatory surgery cancer center from January 2016 to June 2019.
Background: Compared to general anesthesia, regional anesthesia confers several benefits including improved pain control and decreased postoperative opioid consumption. While the benefits of peripheral nerve blocks (PNB) have been well studied, there are little epidemiological data on PNB usage in mastectomy and lumpectomy procedures. The primary objective of our study was to assess national trends of the annual proportion of PNB use in breast surgery from 2010 to 2018.
View Article and Find Full Text PDFStudy Objective: An increasing number of overweight and obese patients are presenting for ambulatory surgical procedures and may be at risk of complications including longer surgeries, longer length of stay (LOS), and possible increase in unanticipated return visits or hospital admissions.
Design: Observational study using prospectively-collected data.
Setting: Freestanding and hospital-based ambulatory surgery facilities.
Although enhanced recovery pathways were initially implemented in inpatients, their principles are relevant in the ambulatory setting. Opioid minimization and addressing pain and nausea through multimodal analgesia, regional anesthesia, and robust preoperative education programs are integral to the success of ambulatory enhanced recovery programs. Rather than measurements of length of stay as in traditional inpatient programs, the focus of enhanced recovery programs in ambulatory surgery should be on improved quality of recovery, pain management, and early ambulation.
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