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Background and ObjectivesLocal infiltration analgesia (LIA) reduces pain after total knee arthroplasty without the motor blockade associated with epidural analgesia or femoral nerve block. However, the duration and efficacy of LIA are not sufficient. A saphenous nerve block, in addition to single-dose LIA, may improve analgesia without interfering with early mobilization.MethodsForty patients were included in this double-blind randomized controlled trial. All patients received spinal anesthesia for surgery and single-dose LIA during the operation. An ultrasound-guided saphenous nerve catheter was placed postoperatively in the adductor canal at midthigh level. Patients were randomized into 2 groups to receive 15-mL boluses of either ropivacaine 7.5 mg/mL or saline twice daily for 2 postoperative days.ResultsWorst pain scores during movement on the day of surgery were significantly lower in the ropivacaine group (median [range] visual analog scale, 3 [0–7] vs 5.5 [0–10]; P < 0.050), as well as pain at rest (visual analog scale, 2 [0–8] vs 4 [0–8]; P = 0.032). Breakthrough pain occurred later in the ropivacaine group (10.5 [range, 0.5–48] hours vs 3.4 [range, 0.5–24] hours; P = 0.011). All patients in the ropivacaine group were able to ambulate on the day of surgery versus 13 patients in the control group (P = 0.004). Fewer patients had sleep disturbance on the first postoperative night in the ropivacaine group (P = 0.038). We found no differences in morphine consumption.ConclusionsThe combination of a saphenous nerve block with single-dose LIA offered better pain relief on the day of surgery than LIA alone.

Background Breakthrough cancer pain (BTcP) has a negative impact on patients’ quality of life, general activities, and is related to worse clinical outcomes. Fentanyl inhalant is a hand-held combination drug-device delivery system providing rapid, multi-dose (25μg/dose) administration of fentanyl via inhalation of a thermally generated aerosol. This multicenter, randomized, placebo-controlled, multiple-crossover, double-blind study evaluated the efficacy, safety, and tolerability of fentanyl inhalant in treating BTcP in opioid-tolerant patients. Methods The trial was conducted in opioid-tolerant cancer patients with 1 ~ 4 BTcP outbursts per day. Each patient was treated and observed for 6 episodes of BTcP (4 with fentanyl inhalant, 2 with placebo). During each episode of targeted BTcP, patients were allowed up to six inhalations, with an interval of at least 4 min between doses. Primary outcome was the time-weighted sum of PID (pain intensity difference) scores at 30 min (SPID30). Results A total of 335 BTcP episodes in 59 patients were treated. The mean SPID30 was -97.4 ± 48.43 for fentanyl inhalant-treated episodes, and -64.6 ± 40.25 for placebo-treated episodes ( p  < 0.001). Significant differences in PID for episodes treated with fentanyl inhalant versus placebo was seen as early as 4 min and maintained for up to 60 min. The percentage of episodes reported PI (pain intensity) scores ≤ 3, a ≥ 33% or ≥ 50% reduction in PI scores at 30 min, PR30 (pain relief scores at 30 min) and SPID60 favored fentanyl inhalant over placebo. Only 4.4% of BTcP episodes required rescue medication in fentanyl inhalant group. Most AEs were of mild or moderate severity and typical of opioid drugs. Conclusion Treatment with fentanyl inhalant was shown to be a promising therapeutic option for BTcP, with significant pain relief starting very soon after dosing. Confirmation of effectiveness requires a larger phase III trial. Trial registration ClinicalTrials.gov: NCT05531422 registered on 6 September 2022 after major amendment, NCT04713189 registered on 14 January 2021.

Objective The aim of this study was to adapt the original English Breakthrough Pain Assessment Tool (BAT) into a Chinese version (BAT-C), following Beaton’s cross-cultural adaptation guidelines, and evaluate its psychometric properties among cancer patients, thereby providing a foundation for the standardized and evidence-based assessment of breakthrough pain in this population. Methods This study employed a cross-sectional design for psychometric validation. The English BAT underwent cultural adaptation according to Beaton’ s cross-cultural adaptation framework to develop the BAT-C. A convenience sampling strategy was utilized to recruit 310 cancer patients with breakthrough pain from four tertiary hospitals in Hebei Province, with data collected to examine the psychometric properties (reliability and validity) of the BAT-C. Results Pre-test analysis revealed no significant ceiling or floor effects. The BAT-C comprises nine items organized into two dimensions—Severity and Impact of Breakthrough Pain, Onset Characteristics and Medication Effectiveness—alongside five open-ended items. Item-level content validity indices (I-CVI) ranged from 0.833 to 1.000, while the scale-level content validity index (S-CVI/Ave) reached 0.976. Exploratory factor analysis extracted two common factors explaining 82.521% of the cumulative variance. Confirmatory factor analysis confirmed acceptable model fit, with indices as follows: χ²/df = 1.733, RMSEA = 0.061, CFI = 0.988, TLI = 0.983, IFI = 0.988, and GFI = 0.953. Convergent validity was confirmed by composite reliability (CR) values of 0.927 and 0.900, and average variance extracted (AVE) values of 0.724 and 0.648. The scale demonstrated a Cronbach’ s α of 0.869 (95% CI: 0.85–0.89, SE: 0.012), with dimension-specific coefficients of 0.937 and 0.861. McDonald’ s ω was 0.947, with a hierarchical ω of 0.675; the Spearman-Brown coefficient was 0.828. Known-groups validity analysis indicated that, after controlling for confounding variables, the BAT-C significantly differentiated patients across ECOG performance statuses ( P  < 0.05, partial η² = 0.021). Conclusion The BAT-C exhibited robust psychometric properties in this sample, providing preliminary support for its clinical utility as an assessment instrument for breakthrough pain in Chinese cancer patients; however, further validation is warranted in larger and more diverse populations.

Purpose Breakthrough cancer pain (BtCP) is a prevalent health issue which is difficult to manage. A plethora of quantitative research in this area exists. There is a paucity of research on the perspectives of health professionals and patients surrounding domains impacting effective treatment, including definitions of BtCP, treatment, and education opportunities. This review aims to identify and synthesize the extent of qualitative research exploring health professional and patient perspectives of BtCP. Methods A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) approach was undertaken. The approach was registered with Prospero. MEDLINE, EMBASE, and Web of Science were searched for peer-reviewed literature published any date prior to May 19, 2022. Eligible sources must have considered health professional and/or patient perspectives of BtCP. A narrative synthesis approach was utilized. Results Three sources met the review criteria. One source explored nurse perspectives, while two sources explored patient perspectives. Study quality was moderate to high. Overlapping themes across the three studies included communication, defining BtCP, impact of BtCP, management of BtCP, perceptions of BtCP, analgesia and pain relief, and training and professional development. Conclusion Given limited research investigating clinician and patient perspectives of BtCP, a rich understanding informed by exploratory qualitative methods around identification, best management strategies, professional development, and factors promoting and inhibiting best practice remains unclear. Further qualitative inquiry is warranted, and it is expected such research will inform BtCP clinical guidelines.

Purpose. This study aimed to characterize breakthrough pain (BTP) and investigate its impact on quality-of-life (QoL) in terminally-ill cancer patients. Similarities and differences between high and low predictable BTP were also tested. Methods. Secondary analysis of a multicenter longitudinal observational study included 92 patients at their end-of-life. BTP was assessed with a short form of the Italian version of the Alberta Breakthrough Pain Assessment Tool. QoL was assessed with the Palliative Outcome Scale (0-40). Patients were stratified by self-reported BTP predictability into unpredictable BTP (never or rarely able to predict BTP) and predictable BTP (sometimes to always able to predict BTP). Results. In all, 665 BTP episodes were recorded (median 0.86 episodes/day). A median duration of 30 minutes and a median peak intensity score of 7 out of 10 were reported. Time to peak was <10 minutes, 10 to 30 minutes, and ≥30 minutes in 267 (41.1%), 259 (39.9%), and 30 (4.6%) of the episodes, respectively. Onset of relief occurred after a median of 30 minutes. Time to peak (P < .001) and duration (P = .046) of BTP was shorter in patients with predictable pain (n = 31), who usually were younger than those with unpredictable pain (P = .03). The mean (SD) QoL score was 14.6 (4.6). No difference in QoL between patients with predictable and unpredictable BTP was found (P = .49). Conclusions. In terminally-ill cancer patients, BTP is a severe problem with a negative impact on QoL and has different characteristics according to its predictability.

BACKGROUND: Intrathecal analgesia (ITA) is a valuable treatment option for refractory cancer-related pain. However, there is still no general consensus on the analgesic effect of movement-evoked breakthrough pain (MEBTP) in the ITA setting. OBJECTIVES: This study aimed to conduct a retrospective observational study to examine the effect of ITA via percutaneous port (ITAPP) with patient-controlled ITA (PCIA) on analgesic efficacy, emphasizing MEBTP in patients with refractory lower extremity cancer pain. STUDY DESIGN: A retrospective chart review included all patients with refractory lower extremity cancer pain who received ITAPP at our hospital between January 2017 and December 2020. METHODS: Data on the Numeric Rating Scale scores of spontaneous resting pain intensity (SRPI) and MEBTP intensity (MEPI), opioid doses, and perceived time to onset were collected from medical records prior to ITAPP and at a one-month postimplant visit. RESULTS: A total of 16 patients were included in the study group. Mean SRPI decreased from 8.75 pre-ITAPP to 3.75 post-ITAPP (P < 0.05); mean MEPI fell from 8.83 pre-ITAPP to 4.25 post-ITAPP (P < 0.05); mean daily morphine equivalent dosing decreased from 360 mg/d to 48 mg/d (P < 0.05); and mean daily morphine equivalent dosing for MEBTP decreased from 87 mg/d to 6 mg/d (P < 0.05). Both total and breakthrough dosing of conventional opioid medications significantly decreased following the initiation of ITAPP with PCIA. The mean perceived time to onset with conventional MEBT medications was 38 minutes, and the mean perceived time to onset with PCIA was 8 minutes (P < 0.05). LIMITATIONS: An effective analysis of IT opioid efficacy was not possible because the power of such a small sample size was low. Second, it is a retrospective study without long-term follow-ups. CONCLUSIONS: In patients with refractory lower extremity cancer pain, ITAPP with PCIA was associated with improved pain control. Compared with conventional MEBTP regimens, appropriate ITAPP with PCIA provided superior analgesia and a much faster onset of action. KEY WORDS: Movement-evoked breakthrough pain, patient-controlled intrathecal analgesia, lower extremity cancer pain, intrathecal analgesia via a percutaneous port

BackgroundOpioids have been the mainstay for postoperative pain relief for many decades. Recently, opioid-related adverse events and death have been linked to postoperative dependency. Multimodal approaches to postoperative pain control may be part of the solution to this health care crisis. The safety and effectiveness of multimodal pain control regimens after laparoscopic Roux-en-Y gastric bypass (LRYGB) has not been well studied. The primary aim of our study was to determine if an evidence-based, multimodal pain regimen during hospitalization could decrease the total oral morphine equivalent (TME) use after LRYGB.Study DesignWe conducted a retrospective cohort study comparing outcomes prior to the implementation of a multimodal pain protocol (December 2010–December 2012) to those after implementation (April 2013–July 2015). The protocol utilized oral celecoxib and scheduled oral acetaminophen for pain control, with opioids used only as needed for breakthrough pain. Data was extracted from an electronic medical record and an institutionally maintained database of all patients undergoing bariatric surgery at a single center.ResultsCompared to controls, the multimodal pain regimen significantly reduced TME used and maximum pain scores with no change in mean pain scores. Multimodal pain protocol patients had a shorter length of stay with no increase in bleeding complications or marginal ulcer rates.ConclusionsAn opioid-sparing multimodal pain regimen adequately controls pain while reducing TME use. The regimen appears to be safe and was associated with a reduced length of stay in patients undergoing LRYGB.

BACKGROUND: Some patients with herpes zoster (HZ) experience an intermittent spontaneous, short-lived and severe pain, which is called breakthrough pain (BTP). The effect of analgesic drugs and invasive procedures is not significant. Therefore, treatment of HZ associated with BTP is challenging. Esketamine is a new N-methyl-D-aspartate receptor antagonist, with enhanced analgesic effects. This study aimed to evaluate the efficacy and adverse reactions of patient-controlled intravenous analgesia (PCIA) with low-dose esketamine for HZ associated with BTP. OBJECTIVES: To evaluate the efficacy and adverse reactions of PCIA with low-dose esketamine for HZ associated with BTP. STUDY DESIGN: A retrospective, observational study. SETTING: The study was carried out in the Pain Department of the Affiliated Hospital of Jiaxing University in Jiaxing, China. METHODS: The clinical data of HZ associated with BTP treated by PCIA with low-dose esketamine at the Pain Department of the Affiliated Hospital of Jiaxing University, between October 2015 to October 2021, were collected retrospectively. The Numeric Rating Scale (NRS-11) scores of rest pain (RP) and BTP, frequency of BTP, Pittsburgh Sleep Quality Index (PSQI) score, and fasting blood glucose (FBG) were recorded and analyzed before treatment (T0) and on days one (T1) and 3 (T2), week one (T3), months one (T4), 3 (T5), and 6 (T6) after treatment. Adverse reactions during the treatment were recorded. RESULTS: Twenty-five patients treated by PCIA with low-dose esketamine were included finally. Compared with T0, the NRS-11 scores of RP at T2, T3, T4, T5, and T6 decreased significantly (P < 0.05). The NRS-11 score of RP at T4 was significantly lower than that of T3 (P < 0.001), but there was no statistical difference between T5 and T4 (P > 0.05), the efficacy of esketamine in the treatment of RP was stable at one month after treatment. Likewise, compared with T0, the NRS-11 scores of BTP, frequency of BTP, and PSQI score decreased significantly at each time point after treatment (P < 0.05). These at T5 were significantly lower than T4 (P < 0.05), but there was no statistical difference between T6 and T5 (P > 0.05), the efficacy of esketamine was stable at 3 months after treatment. FBG also decreased significantly at each time point after treatment (P < 0.05), it tended to be normal and stable one month after treatment. All patients had mild symptoms of dizziness during treatment, and though a slight increase in noninvasive blood pressure (BP) was noted in all, the elevated BP did not exceed 30% of the baseline value. Four patients (16%) developed nausea without vomiting. There were no serious adverse reactions, such as respiratory depression. LIMITATIONS: The nonrandomized, single-center, small sample size, retrospective design is a major limitation of this study. CONCLUSIONS: PCIA with low-dose esketamine has a significant and long-term effect in the treatment of HZ associated with BTP. The RP was controlled, and the degree and frequency of BTP were significantly reduced after treatment, leading to improved quality of life. There were no serious adverse reactions worthy of clinical promotion. KEY WORDS: Patient-controlled intravenous analgesia, esketamine, herpes zoster, breakthrough pain

Background The management of breakthrough pain in cancer patients is always a challenge for medical professions. Occurring in 80% of cancer patients with advanced disease, breakthrough pain significantly decreases both patient’s and caregiver’s quality of life. The aim of this study is to assess the analgesic efficacy of a fixed inhaled nitrous oxide/oxygen mixture for adult cancer patients with breakthrough pain. Methods/design This is a randomized, placebo-controlled, double-blind study; it will be conducted in the General Hospital of Ningxia Medical University. The target study subjects are at least 18 years old, and are hospitalized cancer patients who are receiving routine opioids to control cancer-related pain but still experience breakthrough pain. A total of 240 patients will be recruited and randomly allocated between three treatment groups (A, B, C) and a control group (group D) in a ratio of 3:1. All treatment groups (A, B, C) will receive standard pain treatment (oral immediate-release morphine) plus a pre-prepared nitrous oxide/oxygen mixture, and the control group (D) will receive the standard pain treatment plus oxygen. Patients, doctors, nurses, and data collectors are all blind to the experiment. Assessments will be taken before treatment (T0), at 5 min (T1) and 15 min (T2) during treatment, and at 5 min after treatment (T3). The primary endpoint measures will be the percentage of patients whose pain is relieved at T1, T2, and T3. Secondary outcome measures will include the safety of treatment, adverse events, and satisfaction from both health professionals and patients. Discussion This study aims to provide an effective and practical intervention for a fast breakthrough pain relief and to improve cancer patients’ quality of life significantly. The Evidence-Based Medicine Working Group claim that a randomized, double-blind, placebo-controlled experimental intervention is the most appropriate design to demonstrate its efficacy, so this study could give a new approach to controlling breakthrough pain episodes. Trial registration ChiCTR-INC-16008075 . Registered on 8 March 2016.

Background Cardiac bypass surgery patients have early postoperative interventions that elicit breakthrough pain. We evaluated the use of intranasal fentanyl for breakthrough pain management in these patients. Methods Multimodal analgesia (paracetamol 1 g three times a day, oxycodone 2–3 mg boluses with a patient-controlled intravenous pump) was used in 16 patients (age 49–70 years, weight 59–129 kg) after cardiac bypass surgery. Intranasal fentanyl 100 µg or 200 µg was used to manage breakthrough pain on the first and third postoperative mornings in a randomised order. Blood samples were collected for up to 3 h after fentanyl administration, pain was assessed with a numeric rating scale of 0–10. Plasma fentanyl concentration was assayed using liquid chromatography-mass spectrometry. Body composition was measured with a bioelectrical impedance device. Results Bioavailability of intranasal fentanyl was high (77%), absorption half-time short (< 2 min) and an analgesic plasma concentration ≥ 0.5 ng/mL was achieved in 31 of 32 administrations. Fentanyl exposure correlated inversely with skeletal muscle mass and total body water. Fentanyl analgesia was effective both on the first postoperative morning with chest pleural tube removal and during physiotherapy on the third postoperative morning. The median time of subsequent oxycodone administration was 1.1 h after intranasal fentanyl 100 µg and 2.1 h after intranasal fentanyl 200 µg, despite similar oxycodone concentrations (median 13.8, range 5.2–35 ng/mL) in both fentanyl dose groups. Conclusions Intranasal fentanyl 100 µg provided rapid-onset analgesia within 10 min and is an appropriate starting dose for incidental breakthrough pain in the first 3 postoperative days after cardiac bypass surgery. Clinical Trial Registration EudraCT Number: 2018-001280-22.