Painful Procedures Research Articles

Nonpharmacological Interventions to Mitigate Procedural Pain in the NICU: An Integrative Review.

Small infants experience a myriad of stimuli while in the Neonatal Intensive Care Unit (NICU), with many being painful or stressful experiences, although medically necessary. To determine what is known about nonpharmacological developmental care interventions used in the NICU to mitigate procedural pain of infants born under 32weeks gestation. Five electronic databases were searched: Medline, CINAHL, Scopus, Embase and the Cochrane Library. The inclusion criteria were as follows: experimental and nonexperimental studies from all publication years with infants born at less than 32weeks gestational age; peer-reviewed research articles studying nonpharmacological interventions such as skin-to-skin care, facilitated tucking, nonnutritive sucking, hand hugs, and swaddling; and English language articles. Our search yielded 1435 articles. After the elimination of 736 duplicates, a further 570 were deemed irrelevant based on their abstract/titles. Then, 124 full-text articles were analyzed with our inclusion and exclusion criteria. Twenty-seven studies were reviewed. Sucrose, facilitated tucking, pacifier, skin-to-skin care, and human milk appeared to lessen pain experienced during heel sticks, suctioning, nasogastric tube insertions, and echocardiograms. All nonpharmacological interventions failed to prove efficacious to adequately manage pain during retinopathy of prematurity (ROP) examinations. Evidence review demonstrates that healthcare practitioners should use nonpharmacological measures to help prevent pain from day-to-day procedures in the NICU including heel sticks, nasogastric tube insertions, suctioning, echocardiograms, and subcutaneous injections. Future research is necessary to better understand and measure how pain is manifested by very small premature infants. Specific research on mitigating the pain of examinations for retinopathy of prematurity is also needed.

Enhancing the comfort of hospitalized elderly patients: pain management strategies for painful nursing procedures.

Enhancing the comfort of hospitalized elderly patients: pain management strategies for painful nursing procedures.

(108) ENHANCING PELVIC EXAM COMFORT AND DIAGNOSTIC ACCURACY: REVIEWING THE UTILITY OF NITROUS OXIDE FOR HYPERTONIC PELVIC FLOOR ASSESSMENT

Abstract Introduction Nitrous oxide is an anesthetic, anxiolytic, and analgesic commonly used for general and dental anesthesia, sedation, and severe pain. Studies show that nitrous oxide is also used in several in-office gynecological and urological procedures as a sedative and anxiolytic agent with a safer drug profile than other anesthetic agents. It is also being trialed as a treatment for mood disorders. Nitrous oxide does not render individuals unconscious, making it a more favorable option for stressful and painful medical procedures than general anesthesia because it allows the patient to feel more in control of their body and aware of the proceedings. Objective To analyze the use of in-office nitrous oxide during medical procedures and evaluate its effectiveness in reducing pain and anxiety levels to predict the utility of it during pelvic exams in patients with vestibulodynia. Methods A literature review was performed through the PubMed database between 2007-2022. The authors independently and thoroughly screened abstracts and full-text articles and assessed the relevant medical literature that acknowledged the use of nitrous oxide in in-office medical procedures. Key terms used to refine the search include [“nitrous oxide in medical procedures”], [“nitrous oxide in gynecology”], [“nitrous oxide in urology”]. Results One study explored the use of nitrous oxide during childbirth in women diagnosed with PTSD, and the results were significant for nitrous oxide reducing PTSD symptom severity. Multiple studies suggest the use of nitrous oxide during dental procedures reduces patient anxiety; one specifically measured sixty anxious patients pre- and post-endodontic procedures and noted a significant reduction in anxiety during the procedure with the use of nitrous oxide. Various studies of gynecological and urological procedures report the successful use of nitrous oxide in reducing peri-procedural pain compared to other analgesic alternatives. A common example is its use during intrauterine device insertion, which is correlated with higher patient satisfaction as it decreases pain. Additionally, a study among patients undergoing extracorporeal shockwave lithotripsy found no significant difference between the use of meperidine, an opioid, and nitrous oxide in post-procedural Visual Analog Scale pain scores with no adverse events reported in the nitrous oxide group. Another study revealed that using local anesthesia in transrectal prostate biopsies resulted in some patients experiencing notable anxiety and pain. At the same time, no such relationship was observed among patients who received nitrous oxide before this procedure. Conclusions Vestibulodynia is a subset of genitopelvic pain isolated to the vulvar vestibule. Vestibulodynia has three proposed etiologies: tissue neural proliferation, musculoskeletal, and hormonally mediated. Discriminating these three etiologies can be difficult, especially when a proper pelvic exam cannot be achieved due to patients’ discomfort. The three etiologies are biologically intertwined, often resulting in vestibulodynia patients experiencing pelvic floor hypertonicity without regard to specific etiology. A painful pelvic exam is stressful and often an anxiety-producing experience for patients with pelvic hypertonicity and vulvodynia. Hence, with the data provided, we suspect that nitrous oxide will be a useful treatment option to mitigate these consequences for the patient, with the added benefit of easing the exam for the provider, leading to a more accurate diagnosis. Disclosure No.

Regional anesthesia in a patient with primary ciliary dyskinesia: A case report

BACKGROUND Primary ciliary dyskinesia (PCD) is an inherited autosomal-recessive disorder of impaired mucociliary clearance characterized by chronic respiratory diseases, otolaryngological diseases, central nervous system abnormalities, reproductive system abnormalities, and cardiac function abnormalities. General anesthesia in these patients is associated with a higher incidence of respiratory complications than in patients without the disease. CASE SUMMARY A 16-year-old male patient was referred to the emergency room complaining of right ankle pain due to distal tibiofibular fracture. Three years prior, he had been diagnosed with PCD. At that time, he had experienced several episodes of pneumonia, sinusitis, and chronic middle ear infections, for which he underwent surgical interventions. At the current admission, he presented with cough and sputum but no other respiratory symptoms. A chest computed tomography scan revealed centrilobular ground-glass opacities in both lower lobes and a calcified nodule in the left lower lobe. For the surgical procedure and postoperative pain management, combined spinal-epidural anesthesia was employed. The patient’s postoperative pain score was measured by the numerical rating scale (NRS). On the day of surgery, his NRS was 5 points. By the second postoperative day, the NRS score had decreased to 2–3 points. The epidural catheter was removed on the fourth day following the operation. The patient was subsequently discharged no respiratory complications. CONCLUSION We performed combined spinal-epidural anesthesia in a patient with PCD. The patient experienced no additional respiratory complications and was discharged with a low NRS score for pain.

A scoping review of the epidemiology and treatment of painful procedures in hospitalized neonates: What has changed in the past three decades?

Care of newborns hospitalized in the neonatal intensive care unit (NICU) includes multiple painful procedures/day. Epidemiologic studies have reported the frequency and nature of procedures and treatment interventions. However, evidence on the changing trends in the nature and frequency of neonatal pain procedures or treatments over time is absent or inconclusive. We aimed to determine the frequency and nature of painful procedures/neonate/day in the NICU. MEDLINE and Embase searches were conducted from database inception to July 2023. Studies that reported the nature and frequency of painful procedures and associated pain treatments in neonates were included. Standard inverse-variance random-effects meta-analyses were used to combine studies. Heterogeneity between studies was quantified using the I2 statistic. Of 2622 unique citations, 64 full-text articles were reviewed; 23 were included. Six additional studies identified in a previous review, and six publications from reference lists were added, resulting in 35 studies. The mean number of painful procedures/neonate/day was 7.38 (95% CI 5.60, 9.17; range <2 to 17). Although the frequency of painful procedures in more recent studies was reduced, it was not statistically significant (p = 0.16). Painful procedures were more frequent during longer observation periods. Needle-related procedures were most common and did not change over time. Procedure-related treatment was suboptimal and inconsistently reported. Frequency of painful procedures in the NICU has shown a clinically important decrease but has not significantly changed over time. A paradigm shift moving responsibility from providers to systems in changing pain practices in the NICU is required. The decrease in the daily frequency of painful procedures in hospitalized neonates might be clinically relevant but is not yet statistically significant. Pain treatment is insufficiently documented and reported. This lack of progress in neonatal care might be a result of the complexity of defining pain and stress; inconsistencies in determining the burden of procedural pain; the influence of barriers and facilitators on practice change; and the focus on an individual rather than system responsibility for pain prevention and treatment.

Effectiveness of cartoons for children's procedural pain: a systematic review with meta-analysis.

BACKGROUND: Cartoons are widely used distraction techniques for nonpharmacological management of procedural pain in pediatric settings. There are a few studies in the literature evaluate the effect of intervention on procedural pain, but a systematic review aimed at providing a summary of the overall effect is lacking. AIM: To summarize the available evidence on effectiveness of cartoons for children’s procedural pain. METHODS: Searching for parallel-group controlled trials was carried out on thirteen biomedical databases, five trial registries, web resources and gray literature sources from each database or resource setup date to 22 January 2023. Primary outcome was procedural pain, secondary outcome was anxiety. RoB 2 and ROBINS-I were used to assess risk of bias of included studies. RESULTS: 24 trials were selected for this review, which included a total of 3046 pediatric subjects. Children who watch cartoons during medical procedures experience less pain (SMD= -1.29; 95% CI: -1.75, -0.83; N=2239) and anxiety (UMD= -1.75; 95% CI: -2.94, -0.56; N=552) compared to children provided standard of care; for both outcomes, results are statistically significant. GRADE method shows moderate certainty/quality of evidence. CONCLUSIONS: Cartoons are more effective than standard of care in reducing procedural pain and anxiety in children. Pending future studies confirming the results, we recommend their implementation in daily clinical practice even in care settings with limited resources.

Effects of pain, sedation and analgesia on neonatal brain injury and brain development

Critically ill newborns experience numerous painful procedures as part of lifesaving care in the Neonatal Intensive Care Unit. However, painful exposures in the neonatal period have been associated with alterations in brain maturation and poorer neurodevelopmental outcomes in childhood. The most frequently used medications for pain and sedation in the NICU are opioids, benzodiazepines and sucrose; these have also been associated with abnormalities in brain maturation and neurodevelopment making it challenging to know what the best approach is to treat neonatal pain. This article provides clinicians with an overview of how neonatal exposure to pain as well as analgesic and sedative medications impact brain maturation and neurodevelopmental outcomes in critically ill infants. We also highlight areas in need of future research to develop standardized neonatal pain monitoring and management strategies.

No pain relief by virtual reality during hysterosalpingography (HSG): results from a randomized controlled trial.

Is virtual reality (VR) an effective non-pharmacological tool to reduce procedural pain during hysterosalpingography (HSG)? An HSG with VR does not reduce procedural pain scores compared to an HSG without VR. An HSG is often experienced as painful and uncomfortable. VR has been proven successful to reduce acute procedural pain during a variety of medical procedures and interventions. We performed a two-centre open-label randomized controlled trial between January 2021 and October 2022. Women scheduled for HSG as part of their infertility work-up were screened for participation. After informed consent, women were randomized between HSG with or without VR. Due to the nature of the intervention, the study was not blinded. VR was administered by a head-mounted device displaying nature movies and/or relaxation exercises. The primary endpoint was procedural pain measured using VAS (scale 0.0-10.0 cm). Procedural pain was divided into overall pain score and peak pain score during the procedure. It was measured immediately after HSG. Secondary endpoints included patient satisfaction, VR preferences, and adverse effects of VR. We included a total of 134 women, 69 to the intervention group (HSG with VR) and 65 to the control group (HSG without VR). The mean VAS for peak pain was 6.80 cm (SD 2.25) in the intervention group versus 6.60 cm (SD 2.40) in the control group (mean difference 0.28 (95% CI -0.57, 1.12), P = 0.52). The mean VAS for overall pain was 5.00 cm (SD 2.10) in the intervention group versus 4.90 cm (SD 2.13) in the control group (mean difference 0.06 (95% CI -0.71, 0.84), P = 0.88). The expectation that VR would be a good distraction from pain during HSG was correlated with both overall and peak pain scores. When correcting for this expectation, we found that women in the intervention group reported significantly higher scores, both in peak (adjusted MD 0.58 (95% CI -0.81, 1.97), P = 0.021) and overall (adjusted MD 0.43 (95% CI -0.84, 1.71), P = 0.013) pain, compared to the control group. There were no differences in the prevalence of symptoms that were considered as adverse effects of VR. The study was not blinded. Reasons for declining participation in the study were anxiety or wanting full control during HSG, which might have created selection bias. The distraction score possibly indicates that the level of VR immersiveness was not optimal due to the lack of sound and/or the type of VR applications. Future studies should investigate whether more immersive or interactive VR applications could decrease procedural pain scores during HSG. Since VR does not reduce procedural pain, this additional tool should not be used during HSG. There was no external funding for this study. KR and AvH report receiving a travel grant from Merck outside the scope of this study. BM is supported by a National Health and Medical Research Council (NHMRC) investigator grant (GNT1176437) and BM reports consultancy for Merck, Organon, and Norgine and travel and research funding from Merck. BM holds stock for ObsEva. CL reports receiving research grants from Merck, and Ferring. KD and VM report receiving travel and speaker's fees from Guerbet and research grants from Guerbet. VM also reports research grants from Merck and Ferring. The remaining authors have nothing to declare. The trial is registered prospectively in the Netherlands Trial Register (trialregister.nl registration number NL9203, currently accessible on trialsearch.who.int). 16-01-2021. The first participant was enrolled on 19 January 2021.

Bridging the Diagnostic Gap between Histopathologic and Hysteroscopic Chronic Endometritis with Deep Learning Models.

Chronic endometritis (CE) is an inflammatory pathologic condition of the uterine mucosa characterized by unusual infiltration of CD138(+) endometrial stromal plasmacytes (ESPCs). CE is often identified in infertile women with unexplained etiology, tubal factors, endometriosis, repeated implantation failure, and recurrent pregnancy loss. Diagnosis of CE has traditionally relied on endometrial biopsy and histopathologic/immunohistochemistrical detection of ESPCs. Endometrial biopsy, however, is a somewhat painful procedure for the subjects and does not allow us to grasp the whole picture of this mucosal tissue. Meanwhile, fluid hysteroscopy has been recently adopted as a less-invasive diagnostic modality for CE. We launched the ARCHIPELAGO (ARChival Hysteroscopic Image-based Prediction for histopathologic chronic Endometritis in infertile women using deep LeArninG mOdel) study to construct the hysteroscopic CE finding-based prediction tools for histopathologic CE. The development of these deep learning-based novel models and computer-aided detection/diagnosis systems potentially benefits infertile women suffering from this elusive disease.

Verbal Support From a Stranger Reduces the Development of Mechanical Hypersensitivity: Behavioral and Neurophysiological Evidence

Hand-holding reduces experimentally induced acute pain and buffers against the development of mechanical secondary hypersensitivity, an indirect proxy of central sensitization. Here, we tested if verbal support from a stranger, a common occurrence in clinical contexts, exerts the same effects. In this preregistered study, 44 healthy female participants were assigned to an alone or support group whereby a supportive female stranger encouraged them through the painful procedure leading to secondary mechanical hypersensitivity. Mechanical hypersensitivity was measured via self-reports and by the size of the anteroposterior and mediolateral spread of mechanical hypersensitivity. We investigated the moderating role of attachment style on self-reports and the effects of support on skin conductance level, salivary cortisol, and pinprick-evoked potentials. We also tested whether theta/beta ratio in the resting-state electroencephalogram predicted mechanical hypersensitivity. Self-reported ratings and the late part of the pinprick-evoked potentials were reduced in the support group, but the spread of mechanical hypersensitivity was not. Attachment anxiety and avoidance moderated the self-reported intensity such that individuals with higher attachment anxiety and avoidance scores reported lower intensity ratings in the support group. No significant effect of the verbal support was observed on skin conductance level and salivary cortisol. The theta/beta ratio did not predict the extent of hypersensitivity. Our data indicate that, in women, verbal support during intense pain leading to hypersensitivity is effective on some behavioral outcomes, but altogether the lack of group differences in cortisol, self-reported stress, and skin conductance does not provide strong support for the stress-buffering hypothesis. PerspectiveVerbal support by a stranger during a painful procedure leading to secondary mechanical hypersensitivity attenuated the development of some measures of mechanical hypersensitivity and associated neural responses in healthy female participants. No evidence was found for the role of stress. Data AvailabilityThe authors will make all data available upon request.

Comparing sucrose solution with distilled water for pain management in premature infant venipuncture: randomized clinical trial.

Managing pain is critical, especially for premature infants undergoing frequent painful procedures. Uncontrolled pain can lead to lasting harm in growth, cognitive development, and future pain responses. A double-blinded clinical investigation involving 150 premature infants was performed in a neonatal intensive care unit. They were randomly divided into three groups: Sucrose 20% (50 infants), distilled water (50 infants), and a control group (50 infants). The infants' behavioral responses were assessed using an infant pain measurement tool before, at 2, and 7 min after the intervention through direct observation. The study revealed that mean pain scores before, 2 min after, and 7 min after the intervention in the sucrose group were (4.78±0.91), (3.18±1.15), and (2±1.02), respectively. In the distilled water group, scores were (4.66±0.89), (3.04±1.15), and (3.08±1.10), while in the control group, they were (4.0±0.79), (4.94±0.79), and (4.72±0.96). The trend of pain scores varied among the groups over time, with a significant difference in mean pain scores at different time points (P<0.001). Initially comparable, pain scores notably decreased after 2 min in the sucrose and distilled water groups (P<0.001), differing from the control group. The study indicated that 20% sucrose and distilled water equally reduce infant pain post-venipuncture, suggesting their viability for clinical pain management. Distilled water, however, provides additional benefits, including economic considerations and ease of preparation.

Lower plasma melatonin levels in non-hypoxic premature newborns associated with neonatal pain

We analyzed plasma melatonin levels in different groups of preterm newborns without hypoxia and their relationship with several perinatal variables like gestational age or neonatal pain. Prospective cohort study of preterm newborns (PTNB) without perinatal hypoxia, Apgar > 6 at 5 min, and oxygen needs on the third day of life. We compared melatonin levels at day 3 of life in different groups of non-hypoxic preterm infants (Student’s t-tests, Mann-Whitney U, and chi2) and analyzed the relationship of melatonin with GA, birth weight, neonatal pain (Premature Infant Pain Profile (PIPP) scale), caffeine treatment, parenteral nutrition, or the development of free radical diseases (correlation study, linear regression) and factors associated with moderate/intense pain and free radical diseases (logistic regression analysis). Sixty-one preterm infants with gestational age (GA) of 30.7 ± 2.0 weeks with no oxygen requirements at day 3 of life were studied with plasma melatonin levels of 33.8 ± 12.01 pg/ml. Preterm infants weighing < 1250 g at birth had lower plasma melatonin levels (p = 0.05). Preterm infants with moderate or severe pain (PPIPP > 5) have lower melatonin levels (p = 0.01), and being preterm with PIPP > 5 is associated with lower plasma melatonin levels (p = 0.03). Being very preterm (GA < 32 GS), having low weight for gestational age (LWGA), receiving caffeine treatment, or requiring parenteral nutrition did not modify melatonin levels in non-hypoxic preterm infants (p = NS). Melatonin on day 3 of life in non-hypoxic preterm infants is not associated with later development of free radical diseases (BPD, sepsis, ROP, HIV, NEC). Conclusion: We observed that preterm infants with moderate to severe pain have lower melatonin levels. These findings are relevant because they reinforce the findings of other authors that melatonin supplementation decreases pain and oxidative stress in painful procedures in premature infants. Further studies are needed to evaluate whether melatonin could be used as an analgesic in painful procedures in preterm infants. Trial registration: Trial registration was not required since this was an observational study.What Is Known:• Melatonin is a potent antioxidant and free radical scavenger in newborns under stress conditions: hypoxia, acidosis, hypotension, painful procedures, or parenteral nutrition.• Pain stimulates the production of melatonin.• Various studies conclude that melatonin administration decreases pain during the neonatal period.What Is New:• Non-hypoxic preterm infants with moderate to severe pain (PIPP>5) have lower levels of melatonin.• Administration of caffeine and treatment with parenteral nutrition do not modify melatonin levels in non-hypoxic preterm infants.

Arnica D30 – an alternative for managing procedural pain in full-term neonates

Background: Despite scientific advances, the management of procedural pain in neonates remains suboptimal. Applying adequate therapy to control pain during the neonatal period is a moral and ethical act. In recent decades, ample evidence has accumulated regarding the risks, associated with both untreated pain and the use of more aggressive analgesic therapy. Thus, the emphasis in neonatal clinical practice is on non-aggressive pain management techniques, including non-pharmacological methods, such as glucose and homeopathic agents. The efficacy and safety of homeopathic agents for reducing procedural pain in neonates is the subject of the present study. Materials and methods: Healthy full-term newborn babies with an average age of 72–84 hours were included. They were divided into three study groups: group (A) – without analgesia, (n = 67), group (B) – analgesic with Arnica D30 (n = 57) and group (C) – analgesic with Sol.Glucose 25% (n = 40). The severity of the pain was assessed using the multimodal - Neonatal Infant Pain Scale (NIPS) and the unimodal - Neonatal Facial Coding System (NFCS) scale. Assessments were done 30s before, 30 seconds after, and 5 minutes after the painful stimulus caused by the heel prick. Heart rate, transcutaneous oxygen saturation, respiratory rate and blood pressure were examined at the same intervals. The results obtained were processed statistically by descriptive analysis and ANOVA at a significance level of p &amp;lt; 0.05. Results: Five minutes after heel prick both scales showed a score near 3, i.e. no significant pain, and statistically significant lower score in those given Arnica D30, compared to those who received Sol.Glucose 25% (p &amp;lt; 0.05). When monitoring the physiological indicators, we found a significant increase in the heart rate 30 seconds after the procedure between group B and C. Five minutes after the heel prick we recorded significantly values of respiratory rate and systolic blood pressure in all three groups compared to accounted for pre-procedural values. Conclusion: Arnica D30 has better analgesic effects compared to Sol.Glucose 25% for newborn babies after heel prick tests.

Evaluation of the Relationship between Pain Exposure and Somatosensory Evoked Potentials in Preterm Infants: A Prospective Cohort Study.

First, to compare somatosensory evoked potentials (SEPs) in preterm newborns without major brain injury studied at term equivalent age (TEA) with a term historical control group. Second, to investigate the impact of pain exposure during the first 28 days after birth on SEPs. Third, to evaluate the association between SEPs and Bayley-III at 2 years corrected age (CA). Infants born at <32 weeks' gestational age (GA) were studied with continuous-SEPs. First, SEP differences between preterm and term infants were analyzed. Second, regression analyses were conducted to explore the association between SEPs and painful procedures, and then between SEPs and neurodevelopment. 86 preterm infants were prospectively enrolled. Preterm infants exhibited prolonged N1 latencies, central conduction times (CCTs), lower N1-P1 amplitudes, and more recurrently abnormal SEPs compared to term infants. Higher pain exposure predicted longer N1 latency and slower CCT (all p < 0.005), adjusting for clinical risk factors. Younger GA and postmenstrual age (PMA) at SEP recording were associated with longer N1 latency and lower N1-P1 amplitude (all p < 0.005). A normal SEP at TEA positively predicted cognitive outcome at 2 years CA (p < 0.005). Pain exposure and prematurity were risk factors for altered SEP parameters at TEA. SEPs predicted cognitive outcome.

Glucose attenuates the long-term adverse neurodevelopment effect of neonate pain stimulus via CRF/GR in rats

BackgroundNeonates undergo numerous painful procedures throughout their hospitalization. Repeated procedural pain may cause adverse long-term effects. Glucose as a non-pharmacological analgesia, is used for neonate pain management. In this study, potential mechanism of attenuate pain induced by glucose in neurodevelopment effect of neonate pain stimulus was investigated. MethodsNeonatal rats to perform a repetitive injury model and glucose intervention model in the postnatal day 0–7(P0-7). Pain thresholds were measured by von Frey test weekly. The puberty behavioral outcome, tissue loss and protein expression in hippocampus were analyzed. ResultsOral administration of glucose after repeated pain stimulation can maintain the hippocampal structure in, and reduce the expressions of corticotropin releasing factor (CFR) and glucocorticoid receptor (GR), therefore, resulted in long-term threshold of pain and cognitive improvement. ConclusionExposure to neonatal repeated procedural pain causes persistent mechanical hypersensitivity and the dysfunction of spatial memory retention at puberty. In addition, glucose can relieve these adverse effects, possibly via decreasing CRF/GR levels to change the hypothalamus-pituitary-adrenal (HPA) axis.

Pilot study of early integration of interventional pain management for patients with chronic cancer pain.

e24080 Background: Pain is a common, distressing, and costly complication of cancer. Treatment guidelines recommend consideration of interventional pain procedures in addition to pharmacotherapy, yet they are underutilized and often only considered for refractory pain despite high-dose opioids. We examined the feasibility of early integration of interventional pain management among ambulatory patients with chronic cancer pain. Methods: This single arm pilot feasibility study recruited patients from outpatient clinics at the Dana-Farber Cancer Institute. Eligible patients had metastatic or locally advanced solid tumors, persistent pain secondary to cancer/cancer treatment, average pain rating of 4 or higher (0-10 scale), and prognosis &gt; 6 months. Patients could not be taking more than 200 oral morphine equivalents per day. Patients were systematically referred to an interventional pain specialist for consideration of pain procedures, with monthly visits for 4 months. Measures of feasibility included the proportion of patients seen by the pain specialist within 4 weeks, and the proportion undergoing pain procedures. Patients completed surveys at baseline, 2 and 4 months; using the Consumer Assessment of Healthcare Providers and Systems (CAHPS), patients rated their satisfaction with pain clinic (range 0-10), and how often the pain doctor treated them with courtesy and respect, listened carefully, and explained things in a way they could understand (range 1-4, higher scores better). Among those undergoing procedures, patients indicated the percent pain relief they had from the procedure. Results: Between May 2022 and October 2023, 30 patients were enrolled (4 remain on study); mean age, 59.5, 50% male, with a variety of solid tumors; baseline “average pain” and “worst pain” scores were 4.3( SD,1.2) and 6.5( SD,1.6). All but one patient (96.7%) was seen in the pain clinic within four weeks; 57% (n = 17) received one or more pain procedure, with 20% (n = 6) undergoing repeat procedures. The most common procedures were neural blockade (8), celiac plexus neurolysis (n = 4), trigger point injection (n = 3), and epidural steroid injection (n = 3). Among patients receiving a procedure, the median percentage relief was 65% (IQR:30,80). Patients rated the quality of care from the pain clinic highly, with a mean score of 8.6( SD,1.6); and were satisfied with their pain physicians with a mean rating of 3.8( SD,0.4) on treating with respect, 3.7( SD,0.6) for listening, and 3.6( SD,0.6) for explaining. Conclusions: In this study of patients with cancer pain, systematic referral to interventional pain management specialists was feasible, and led to most patients receiving a pain procedure. Patients were satisfied with their pain care and reported meaningful relief of symptoms. Further study is needed to examine whether early integration of interventional pain management improves pain control. Clinical trial information: NCT05366413 .

Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)—2-year event-free survival and safety data for Cohort H.

4564 Background: For patients (pts) with MIBC who are cisplatin-ineligible and undergoing radical cystectomy and pelvic lymph node dissection (RC+PLND), no neoadjuvant treatment options have been shown to improve survival. Enfortumab vedotin (EV) is an antibody-drug conjugate directed to Nectin-4, which is highly expressed in urothelial cancer. EV, alone and in combination w/ pembrolizumab, has been shown to improve OS vs chemotherapy in pts with previously treated and untreated locally advanced or metastatic urothelial cancer, respectively (Powles NEJM 2021; Powles ESMO 2023). In Cohort H of the EV-103 phase 1b/2 study, promising results for 1-year EFS and antitumor activity, including pathological complete response (pCR) and pathological downstaging (pDS) rates, were achieved in cisplatin-ineligible pts with MIBC after neoadjuvant monotherapy EV treatment (Petrylak ASCO GU 2022; Flaig ASCO 2023). Here we report updated results, including 2-year EFS. Methods: Cohort H of the EV-103 study enrolled cisplatin-ineligible pts with MIBC (T2-T4aN0M0) and ECOG PS ≤2 who were eligible for RC+PLND. Pts received neoadjuvant EV (1.25 mg/kg) on Days 1 and 8 every 21 days for 3 cycles before undergoing RC+PLND. The primary endpoint was pCR rate (ypT0 and N0) by central pathology review. Key secondary endpoints included pDS rate (ypT0, ypTis, ypTa, ypT1, and N0), safety, and EFS per investigator assessment (radiographic progression prior to RC, failure to undergo RC, gross residual disease at time of RC, recurrence, or death). Results: 22 pts (median age 74.5 years) were enrolled and treated; 15 pts (68.2%) remain on study. Pts had stage cT2 (68.2%), cT3 (27.3%), or cT4 (4.5%) disease. 68.2% of pts had urothelial carcinoma only; 31.8% had a mixed histology. 86.4% of pts completed all 3 cycles of EV; the median duration of EV treatment was 2.1 months (range 0.7-2.3). The pCR rate was 36.4% (95% CI, 17.2-59.3) and the pDS rate was 50.0% (95% CI, 28.2-71.8). The EFS rate at 24 months was 62.0% (95% CI, 38.2-78.9). Median EFS has not been reached. All pts underwent surgery with no delays due to EV-related TEAEs. The most common EV-related TEAEs were fatigue (45.5%), dysgeusia (36.4%), and alopecia (31.8%); 18.2% of pts had grade ≥3 EV-related TEAEs. 68.2% of pts had surgery-related TEAEs: the most common were procedural pain (18.2%), anemia (13.6%), and constipation (13.6%). 3 pts died due to AEs unrelated to EV treatment. 36.4% of pts received subsequent cancer-related therapy. Conclusions: Neoadjuvant EV monotherapy treatment showed promising results for antitumor activity and 2-year EFS with a manageable safety profile in cisplatin-ineligible pts with MIBC. These results support ongoing phase 2 and 3 programs in MIBC evaluating EV alone or combined with pembrolizumab (EV-103 Cohort L, KN-905/EV-303, KN-B15/EV-304). Clinical trial information: NCT03288545 .

Practice makes perfect: Using simulation to build and assess competency in bone marrow biopsy for heme/onc fellows.

9042 Background: The American Board of Internal Medicine (ABIM) requires that Hematology/Oncology fellows demonstrate competence in bone marrow biopsies (BMB). However, offers no guidance in assessment methods. Neither the "see one, do one, teach one" nor the "complete 5 procedures" approach is sufficient to ensure competency. As this is a potentially painful procedure that requires knowledge of landmarks, simulation in a safe environment is an ideal way to introduce BMB to trainees. In 2015, we started a simulation program to teach fellows how to perform BMB using a cadaver pelvis, and assess their BMB competency. Methods: The Hematology Oncology Fellowship Program at Gundersen Health System holds a half-day simulation for our 6 fellows each July. We begin with a self-evaluation of current skills, using an 8-question pre-test. We then view a demonstration video, pausing to discuss key learning points. Fellows are given a detailed check list of the steps of the procedure. They then experiment with the tools of the procedure and practice sterile technique. We discuss the indications, contraindications, consent, and the procedure itself. For part two, fellows are divided into two groups, each consisting of a first year (F1), second year (F2), and third year (F3) fellow. A cadaver pelvis is used as the model and is positioned in a prone position. Each team is assigned a side of the pelvis. The F3 demonstrates the procedure from start to finish while the F2 and staff assesses competency and the F1 follows with the procedure check list. Once the F3 has completed the procedure and is deemed "competent" they become the leader of the session for their team. F1s can practice as many times as desired, under the guidance of the F2 and F3. F2s also have a chance to refine their skills. After the simulation is complete, fellows repeat the self-evaluation, and we debrief. Results: 44 fellows completed the simulation (F1=16, F2=14, F3=14). Questions for the pre- and post-tests were ranked on a 5-point Likert Scale of strongly agree (1) to strongly disagree (5). F1s had the worst self-assessment prior to the procedure, with a mean score of 2.4 for all questions. However, their post-test self-assessment improved to 1.6. F2s started at 1.5 and improved to 1.1 after the simulation. F3s started at 1.2 and improved to 1.0. All fellows answered that this was a useful exercise and should be continued. Comments were consistently positive, speaking to the importance of a check list, the relaxed atmosphere, and having senior fellows teach the junior fellows. Conclusions: BMB simulation allows for a low-stakes introduction to a stressful procedure, while promoting a team approach to learning. It also gives an opportunity to verify competence for graduating fellows. Fellows self-reported improvement following the session as well as from year to year. Fellows value this learning experience and look forward to it each year.

Preliminary evidence for the safety and efficacy of a novel method for removal of contraceptive implants: a pilot RCT

Contraceptive implants are the most effective form of long-acting reversible contraception (LARC). Implant insertion is standardized; however, the recommended removal method, the pop-out method, may be problematic if the implant does not easily pop-out. We evaluated an alternative removal method with a modified incision location, the To method, in a single-blind pilot randomized control trial of 21 patients. Pain differences, success rates, and procedure time between methods were examined. Results demonstrated that the To method was faster and less painful than the pop out method. This study provides preliminary evidence to support using the To method for contraceptive implant removal.

Acute Guillain-Barré Syndrome After Sacroiliac Joint Fusion

BACKGROUND: Guillain-Barré syndrome (GBS), also called acute inflammatory demyelinating polyradiculopathy (AIDP), is one of the most common causes of acute, acquired weaknesses. GBS is an acute immune-mediated polyneuropathy that presents with progressive weakness of the arms or legs. GBS presents after infection; however, there are few reports that describe acute GBS after chronic pain procedures. CASE REPORT: A 70-year-old man with a past medical history of spinal stenosis status post anterior cervical discectomy and fusion, sacroiliac joint (SIJ) dysfunction status post SIJ fusion presented with imbalance, weakness, and difficulty walking. The patient underwent SIJ fusion one week prior; his weakness progressively worsened, requiring a walker. He underwent a series of labs and diagnostic tests, which were consistent with AIDP/GBS. He was placed on respiratory and cardiac monitoring and started on intravenous immunoglobulin treatment. He started developing bilateral facial palsies and started on plasmapheresis. His symptoms have improved and he was discharged from our inpatient rehab facility on after 28 days. CONCLUSIONS: This case report aims to highlight a rare, but potentially dangerous, complication of AIDP/GBS following an SIJ fusion. KEY WORDS: Sacroiliac joint fusion, sacroiliac joint pain, Guillain-Barré syndrome, case report