The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial.

BACKGROUND: Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic efficacy with opioid reduction remains unknown. Perioperative ketamine infusions can decrease opioid consumption and opioid-related side effects. However, as opioid requirements are drastically minimized within ERAS models, the differential effects of ketamine within an ERAS pathway remain unknown. We aim to pragmatically investigate through a learning healthcare system infrastructure how the addition of a perioperative ketamine infusion to mature ERAS pathways affects functional recovery. METHODS: The IMPAKT ERAS trial (IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery) is a single center, pragmatic, randomized, blinded, placebo-controlled trial. 1544 patients undergoing major abdominal surgery will be randomly allocated to receive intraoperative and postoperative (up to 48 h) ketamine versus placebo infusions as part of a perioperative multimodal analgesic regimen. The primary outcome is length of stay, defined as surgical start time until hospital discharge. Secondary outcomes will include a variety of in-hospital clinical end points derived from the electronic health record. DISCUSSION: We aimed to launch a large-scale, pragmatic trial that would easily integrate into routine clinical workflow. Implementation of a modified consent process was critical to preserving our pragmatic design, permitting an efficient, low-cost model without reliance on external study personnel. Therefore, we partnered with leaders of our Investigational Review Board to develop a novel, modified consent process and shortened written consent form that would meet all standard elements of informed consent, yet also allow clinical providers the ability to recruit and enroll patients during their clinical workflow. Our trial design has created a platform for subsequent pragmatic studies at our institution. TRIAL REGISTRATION: NCT04625283, Pre-results.

Unanticipated Consequences of Switching to Sugammadex: Anesthesia Provider Survey on the Hormone Contraceptive Drug Interaction.

BACKGROUND: Sugammadex binds progesterone with high affinity and may interfere with hormonal contraceptive effectiveness. The clinical, economical, and ethical implications of unintended pregnancy should prompt anesthesiologists to actively consider and manage this pharmacologic interaction. We surveyed anesthesiology providers at our institution about knowledge of this potential adverse drug interaction, how they manage it clinically, and the extent to which they involve patients in shared decision-making regarding choice of neuromuscular blocker antagonist. METHODS: A survey instrument was distributed to anesthesiology providers at a large, tertiary-care medical center. The survey explored prior experience using neostigmine and sugammadex, knowledge about potential sugammadex interference with hormonal contraception, pre-/postoperative counseling practices, clinical management, and shared decision-making regarding potential use of neostigmine in lieu of sugammadex to avoid this drug-drug interaction. RESULTS: Of 259 surveys distributed, 155 were fully completed, and 10 were partially completed. Overall response rate was 60% (residents 85%, student nurse anesthetists 53%, certified registered nurse anesthetists 58%, attendings 48%). All but 1 respondent recognized the potential for sugammadex interference with oral hormonal contraception. Far fewer accurately identified potential interference with hormonal intrauterine devices (44%) and hormonal contraceptive implants (55%). The manufacturer's recommended 7-day duration of alternative contraception was correctly identified by 72% of respondents; others (22%) reported longer durations (range 10-30 days). Most (78% overall) agreed/strongly agreed that potential interference with contraceptive effectiveness should be discussed with patients preoperatively. Despite the majority (86% overall) that endorsed shared decision-making and inviting patient input regarding choice between sugammadex and neostigmine, many respondents reported "rarely/never" having discussed this drug interaction with patients in actual clinical practice, either preoperatively (67%) or postoperatively (80%). Furthermore, most respondents (79%) reported "rarely/never" administering neostigmine to intentionally avoid this drug interaction. CONCLUSIONS: Two years after designating sugammadex as antagonist of choice, physician and nurse anesthesia providers reported seldom inquiring about contraceptive use among women of childbearing potential and rarely discussing potential risk of contraceptive failure from sugammadex exposure. Most lack accurate knowledge of sugammadex interference with hormonal intrauterine and subcutaneous contraceptive devices. Although most endorse preoperative counseling and support patient autonomy or shared decision-making regarding choice of reversal agent, the same respondents report rarely, if ever, actualizing these positions in clinical practice. These conflicting findings highlight the need for education regarding residual neuromuscular block versus adverse drug interactions, collaboration among providers involved in patient counseling, and intentional mindfulness of reproductive justice when caring for women of childbearing potential.

Sugammadex Administration in Pregnant Women and in Women of Reproductive Potential: A Narrative Review.

Since its clinical introduction in 2008, sugammadex has demonstrated a high degree of safety and superior effectiveness compared to neostigmine when used to antagonize muscle relaxation produced by steroid nondepolarizing neuromuscular blockers. This includes its use in special populations, such as the elderly, children over 2 years old, and patients with renal, hepatic, or lung disease. In contrast, clinical evidence guiding its use during pregnancy, in women of childbearing potential, and in lactating women, is sparse. An exception is administration at the end of surgery in parturients undergoing cesarean delivery (CD) with general anesthesia (GA), for whom effectiveness and safety evidence is rapidly accumulating. We review evidence regarding sugammadex rescue reversal shortly after high-dose rocuronium in cases of cannot intubate/cannot ventilate (CICV), the extent of placental transfer of maternally administered sugammadex, adverse fetal effects of sugammadex exposure, potential effects on maintenance of early pregnancy, and the extent of transfer to breast milk. Finally, many anesthesiologists appear to heed the manufacturer's warning regarding informing women of childbearing potential regarding the risk of hormone contraceptive failure after sugammadex exposure. We provide a medical ethics analysis of the ex post facto counseling commonly reported after sugammadex administration, which favors either preoperative discussion and shared decision making, or the decision by the physician to use neostigmine. This review highlights the disparity in evidence regarding sugammadex use in various contexts of female reproductive health, including current research gaps that prevent this population from sharing in the benefits of sugammadex enjoyed by most perioperative patients.

Use of the American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator During Preoperative Risk Discussion: The Patient Perspective.

BACKGROUND: The American College of Surgeons (ACS) National Surgical Quality Improvement Program Surgical Risk Calculator (ACS Calculator) provides empirically derived, patient-specific risks for common adverse perioperative outcomes. The ACS Calculator is promoted as a tool to improve shared decision-making and informed consent for patients undergoing elective operations. However, to our knowledge, no data exist regarding the use of this tool in actual preoperative risk discussions with patients. Accordingly, we performed a survey to assess (1) whether patients find the tool easy to interpret, (2) how accurately patients can predict their surgical risks, and (3) the impact of risk disclosure on levels of anxiety and future motivations to decrease personal risk. METHODS: Patients (N = 150) recruited from a preoperative clinic completed an initial survey where they estimated their hospital length of stay and personal perioperative risks of the 12 clinical complications analyzed by the ACS Calculator. Next, risk calculation was performed by entering participants' demographics into the ACS Calculator. Participants reviewed their individualized risk reports in detail and then completed a follow-up survey to evaluate their perceptions. RESULTS: Nearly 90% of participants desire to review their ACS Calculator report before future surgical consents. High-risk patients were 3 times more likely to underestimate their risk of any complication, serious complication, and length of stay compared to low-risk patients (P < .001). After reviewing their calculated risks, 70% stated that they would consider participating in prehabilitation to decrease perioperative risk, and nearly 40% would delay their surgery to do so. Knowledge of personal ACS risk calculations had no effect on anxiety in 20% and decreased anxiety in 71% of participants. CONCLUSIONS: The ACS Calculator may be of particular benefit to high-risk surgical populations by providing realistic expectations of outcomes and recovery. Use of this tool may also provide motivation for patients to participate in risk reduction strategies.

A qualitative analysis of parturients' experiences using nitrous oxide for labor analgesia: It is not just about pain relief.

BACKGROUND: A vast majority of women who choose nitrous oxide for labor report high satisfaction despite variable analgesic effectiveness. We analyzed comments provided by women who used nitrous oxide for labor, to identify determinants of satisfaction in this population, and to better understand reasons for continuing with nitrous oxide despite variable analgesic effectiveness. METHODS: We conducted qualitative content analysis of comments in a quality improvement database of routine follow-up assessments of women who delivered vaginally, using nitrous oxide as the sole labor analgesic. An inductive grounded approach was used and emergent themes and subthemes were identified. RESULTS: Of 6507 vaginal deliveries over 34 months in 2011-2014, 753 (12%) used nitrous oxide as their sole analgesic. Analysis of 264 clarifying comments yielded six emergent themes. Parturients cited nonanalgesic benefits of nitrous oxide use (relaxation, distraction, focus on breathing), as well as partial analgesic effects that they deemed to be sufficient, or consistent with their expectations. Numerous women described their nitrous oxide experience as consistent with their birth plan, including 14 who equated it with natural childbirth. Several comments described nitrous oxide as a vital component of the parturients' birth experience. Some described using nitrous oxide when neuraxial analgesia was not possible. Side effects were identified, as were difficulties using the apparatus/mask. Analysis highlighted importance of timely administration upon request and attention to technical aspects. CONCLUSIONS: Among parturients who choose nitrous oxide as their sole labor analgesic, determinants of satisfaction are more variable than previously understood, and extend beyond analgesia.

The opioid epidemic and pregnancy: implications for anesthetic care.

PURPOSE OF REVIEW: This review summarizes evolving knowledge regarding adverse maternal, fetal, and neonatal effects of opioid exposure during pregnancy, and current treatment options for opioid use disorder (OUD). Maternal and fetal implications of maternal opioid maintenance with methadone and buprenorphine are described. Finally, acute and chronic pain management strategies in opioid-tolerant parturients are reviewed. RECENT FINDINGS: Opioid use among parturients has risen dramatically, with opioid use during pregnancy as high as 20%. Of women with chronic pain, most continue to take opioids during pregnancy. Medication-assisted therapy with methadone or buprenorphine is currently the standard for treatment of opiate use disorder. Buprenorphine has unique pharmacologic properties that account for its preference over methadone. It has also been shown to produce more favorable neonatal outcomes compared with methadone. Increased clearance and volume of distribution associated with pregnancy require adjustment of dosing regimens of both medications. Multimodal adjuncts can be important alternatives for treatment of pain in opioid-tolerant parturients. SUMMARY: The dramatic rise in OUD in pregnancy has had staggering socioeconomic consequences, carrying with it profound maternal and fetal health problems. Medication-assisted treatment utilizing either methadone, or more commonly buprenorphine, is considered the standard of care for OUD during pregnancy. Peripartum pain management for opioid-tolerant patients is challenging and requires consideration for regional anesthesia along with multimodal pharmacotherapy.

Effectiveness of Oral Iron Therapy in Anemic Inpatient Pregnant Women: A Single Center Retrospective Cohort Study.

Background and aim Oral iron therapy is effective in treating iron deficiency anemia in outpatient pregnant women but has not been studied in inpatient pregnant women. We aimed to evaluate the effect of oral iron therapy versus no therapy during hospitalization on maternal and neonatal outcomes in women with anemia who are hospitalized for pregnancy-related morbidities (i.e., preterm premature rupture of membranes, preterm labor, pre-eclampsia, abnormal placentation, or fetal monitoring). Methods A retrospective, single-center study was conducted in hospitalized pregnant women (2018 to 2020) with inpatient stays of more than three days. The primary outcome was a change in hemoglobin level from admission to delivery in women treated with oral iron compared with those left untreated. Secondary outcomes included the total amount of iron administered before delivery, the time interval from admission to delivery, and neonatal effects. Results Two hundred sixty-three women were admitted, 79 women had anemia, and 29 (36.7%) received at least one dose of oral iron. Baseline patient characteristics were similar between groups. The median (interquartile range) dose of iron in the oral iron group was 1185.0 (477.0, 1874.0) mg. Neither absolute hemoglobin before delivery (control group: 10.0±1.2 g/dL; iron group: 10.1±1.1 g/dL; p=0.774) nor change in hemoglobin from admission to delivery (control group: -0.1±1.1 g/dL vs. iron group: 0.4±1.1 g/dL; p=0.232) differed between groups. Women in the control group had shorter length of stay (LOS) median (IQR) than women in the iron group (control group: 7.1 (5.0, 13.7) days; iron group: 11.4 (7.4, 25.9) days; p=0.03). There were no differences in maternal mode of delivery, though each group had high rates of cesarean delivery (control group: 53.7%; iron group: 72.4%; p=0.181). There were no differences in estimated blood loss at delivery (control group: 559±401; iron group: 662.1±337.4;p=0.264) in either group. Neonatal birthweight (control group: 1.9±0.7 kg; iron group: 1.9±0.7 kg; p=0.901), birth hemoglobin (control group: 16.3±2.2 g/dL; iron group: 16±2.2 g/dL; p=0.569), neonatal intensive care unit (NICU) admission (control group: 93.3%; iron group: 84.8%;p=0.272 ), or neonatal death (control group: 8.9%; iron group: 3%; p=0.394) were not different between groups. Conclusions Oral iron administered to anemic inpatient pregnant women was not associated with higher hemoglobin concentrations before delivery. Lack of standardized iron regimens and short hospital stays may contribute to the inefficacy of oral iron for this inpatient pregnant population. The small sample size and retrospective nature of this study are limiting factors in drawing conclusive evidence from this study.

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial.

BACKGROUND: Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic efficacy with opioid reduction remains unknown. Perioperative ketamine infusions can decrease opioid consumption and opioid-related side effects. However, as opioid requirements are drastically minimized within ERAS models, the differential effects of ketamine within an ERAS pathway remain unknown. We aim to pragmatically investigate through a learning healthcare system infrastructure how the addition of a perioperative ketamine infusion to mature ERAS pathways affects functional recovery. METHODS: The IMPAKT ERAS trial (IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery) is a single center, pragmatic, randomized, blinded, placebo-controlled trial. 1544 patients undergoing major abdominal surgery will be randomly allocated to receive intraoperative and postoperative (up to 48 hours) ketamine versus placebo infusions as part of a perioperative multimodal analgesic regimen. The primary outcome is length of stay, defined as surgical start time until hospital discharge. Secondary outcomes will include a variety of in-hospital clinical end points derived from the electronic health record. DISCUSSION: We aimed to launch a large-scale, pragmatic trial that would easily integrate into routine clinical workflow. Implementation of a modified consent process was critical to preserving our pragmatic design, permitting an efficient, low-cost model without reliance on external study personnel. Therefore, we partnered with leaders of our Investigational Review Board to develop a novel, modified consent process and shortened written consent form that would meet all standard elements of informed consent, yet also allow clinical providers the ability to recruit and enroll patients during their clinical workflow. Our trial design has created a platform for subsequent pragmatic studies at our institution. TRIAL REGISTRATION NUMBER: NCT04625283, Pre-results Protocol Version 1.0, 2021.

Opioid-Sparing Perioperative Analgesia Within Enhanced Recovery Programs.

Opioid-based analgesia in the perioperative period can provide excellent pain control, but this approach exposes the patient to avoidable side effects and possible harm. Optimal analgesia, an approach that targets the fastest functional recovery with adequate pain control while minimizing side effects, can be achieved with opioid minimization. Many different options for nonopioid multimodal analgesia exist and have been shown to be efficacious, with certain modalities being more beneficial for specific surgeries. This review will present the evidence and practical tips for these management strategies.

Post-cesarean gabapentin is not associated with lower opioid consumption or pain scores in women on chronic buprenorphine therapy: A 10-year retrospective cohort study.

STUDY OBJECTIVE: To determine if postoperative gabapentin administration is associated with decreased opioid consumption or pain scores following cesarean delivery in women on chronic buprenorphine. DESIGN: Retrospective cohort study. SETTING: Postoperative recovery area and postpartum inpatient unit. PATIENTS: 214 women undergoing cesarean delivery while on chronic buprenorphine at a single institution between 2007 and 2017. INTERVENTIONS: Gabapentin treatment for post-cesarean analgesia. MEASUREMENTS: The primary outcome was opioid consumption in morphine milligram equivalents, comparing patients who received ≥1 dose of gabapentin within 24 h of cesarean delivery to those who did not. Secondary outcomes included opioid consumption 24-48 and 48-72 h post-cesarean and postoperative numerical rating scale pain scores. MAIN RESULTS: Of 214 included patients, 64 (30%) received gabapentin while 150 (70%) did not. Gabapentin patients were more likely than controls to have received neuraxial fentanyl (30% vs. 14%, p = 0.01) and transversus abdominis plane block (6% vs. 1%, p = 0.05) and overall received higher doses of ketorolac and acetaminophen. Control patients were more likely to have received neuraxial morphine (78% vs. 90%, p = 0.04) and received higher doses of ibuprofen. In unadjusted analysis, there was no significant difference in morphine milligram equivalent consumption 0-24 h postoperatively between gabapentin (55 mg [IQR 26,84]) and control (53 mg [IQR 28,75]) groups (p = 0.38). After controlling for potential confounders, there remained no significant effect of gabapentin administration (overall effect p = 0.99). Opioid consumption and pain scores were also not significantly different at any other time points. CONCLUSIONS: In parturients receiving chronic buprenorphine, inclusion of gabapentin in a multimodal analgesic regimen was not associated with lower opioid consumption or pain scores during the first 72 h after cesarean delivery. Prospective randomized studies are needed to confirm these findings.

The Impact of Converting From an 'Educator-Driven' to a 'Learner-Initiated' Feedback Model.

BACKGROUND: Modern approaches to clinical evaluation emphasize the value of learner-driven feedback models, where trainees are encouraged to take an active role in the initiation of the evaluation process. In an effort to empower medical students to request evaluations on performance, our medical school developed a web-based application for mobile devices that prompts learners to solicit feedback electronically following a clinical encounter. In 2016, mandatory implementation of this application resulted in a transition from an educator-driven feedback model to a learner-driven feedback model. We aimed to investigate the impact of this innovative system on both the quality and quantity of feedback provided to medical students on their anesthesiology elective. METHODS: We retrospectively analyzed medical students' feedback data from the sequential academic years prior to and after the implementation of our learner-driven feedback application. Quantitative analysis was performed to compare the frequency of evaluations requested and completed. Free-text commentary was analyzed using conventional qualitative content analysis. Comments were categorized by quality and representative themes based upon Accreditation Council for Graduate Medical Education Core Competency domains. RESULTS: A total of 297 evaluations for 72 students were analyzed. Students in the learner-driven model requested feedback more frequently than the previously educator-driven system (13.4 vs 8.9 requests per student, P < .0001). Additionally, a greater proportion of assessments were completed by evaluators when solicited from the learner-driven model (42% vs 34%, P = .0265). The quality of comments solicited from the learner-driven model were of higher quality when addressing students' strengths (71% vs 30%, P < .00001) and of lower quality when addressing areas of improvement (73% vs 59%, P = .0378). Comments from the learner-driven model were more likely to address Patient Care (48% vs 24%, P < .00001) and less likely to address Interpersonal and Clinical Communication (17% vs 28%, P = .0037) compared to the educator-driven model. CONCLUSIONS: A learner-driven feedback model was successful in improving the quantity of both requested and completed evaluations for students. The quality of feedback was also improved when addressing students' strengths.

Brief Report -The Current State of Biomedical Ethics Education Among Anesthesiology Training Programs: A Call to Arms.

BACKGROUND: Anesthesiology presents unique challenges to the discipline of biomedical ethics, as providers must practice ethical principles under high-stress and time-restricted conditions. The American Board of Anesthesiology has recognized the value of ethical competence through incorporation of ethics-based scenarios on the Advanced and Applied Exams. Accordingly, we performed a needs assessment and gap analysis of the current state of biomedical ethics training among anesthesiology residency programs. METHODS: A survey instrument was formed to assess existing ethics curricula and to identify perceived interest and barriers to integrating a formal ethics curriculum into residency training. The survey was distributed online to anesthesiology residency program directors in the United States. RESULTS: The survey was distributed (N = 150) with a response rate of 53% (n = 79). Half the respondents reported providing formal ethics training in their program, which averaged 3.8 ± 1.6 h/year. Only 58% of respondents agreed that their residents were competent at managing biomedical ethical dilemmas upon graduation. The lack of a preestablished curriculum, knowledgeable faculty, and time were the most cited barriers to providing ethics training. Most respondents expressed interest in using a standardized ethics curriculum if offered by a credible academic society and believed it should be a requirement during training. CONCLUSION: Our needs analysis is reflective of considerable interest among anesthesiology program directors to use a uniform biomedical ethics curriculum for trainees, with a majority (n = 53, 68%) endorsing it as a proposed requirement for graduation.

Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether individualized postdischarge oxycodone prescribing guided by inpatient opioid use reduces the number of unused opioid tablets after cesarean birth. METHODS: We conducted a randomized, controlled trial of women aged 18 years or older undergoing cesarean birth. Participants were randomized at discharge in a 1:1 ratio to a standard (30 tablets of 5 mg oxycodone) or an individualized oxycodone prescription (predicted based on each patient's inpatient opioid use). All women were contacted starting 14 days after cesarean birth to assess number of oxycodone tablets used and adequacy of pain control. The Tennessee Controlled Substance Monitoring Database was accessed to confirm dispensed opioids. The primary outcome was number of unused oxycodone tablets prescribed for pain control after cesarean birth. A total sample size of 160 women was necessary to detect a 30% difference in leftover tablets between groups with 80% power and α of 0.05. RESULTS: Between June 14, 2017, and August 26, 2017, we screened 323 women and randomized 172. Baseline characteristics and inpatient opioid use were similar between groups. Women in the individualized group were prescribed fewer tablets (14 [interquartile range 12-16] vs 30 [interquartile range 30-30], P<.001) and had 50% fewer unused tablets than women in the standard group (5 [interquartile range 1-8] vs 10 [interquartile range 0-22], P<.001). Overall, 13% (23/172) used no opioids after discharge and 26% (44/172) used all prescribed opioids. There were no differences between the standard and individualized groups in the proportion of women who used no opioids or all opioids and no difference in the proportion of dispensed opioids used (60% [interquartile range 23-100] vs 61% [29-89], P=.93). Women in the individualized group used only half the number of prescribed opioids as women in the standard group (8 [interquartile range 4-14] vs 15 [interquartile range 6-30], P<.001). Patient-reported pain outcomes did not differ significantly by group. CONCLUSION: Individualized opioid prescribing based on inpatient use reduces the number of unused oxycodone tablets compared with standard prescribing. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov, NCT03168425.