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Stir-up Regimen After General Anesthesia in the Postanesthesia Care Unit: A Nurse Led Stepped Wedge Cluster Randomized Control Trial

J Perianesth Nurs. 2023 Nov 16:S1089-9472(23)00888-2. doi: 10.1016/j.jopan.2023.07.014. Online ahead of print.

ABSTRACT

PURPOSE: To implement a standardized Stir-up Regimen (deep breathing, coughing, repositioning, mobilization [moving arms/legs], assessing and managing pain and nausea) within the first 30 minutes of arrival in the postanesthesia care unit (PACU), with a goal of decreasing recovery time in the immediate postanesthesia period (Phase I).

DESIGN: A pragmatic stepped wedge cluster randomized control trial. Initially, data were collected on time in Phase I in three PACUs (control). Subsequently, the same three units were randomized to sequentially transition to the Stir-up Regimen (intervention).

METHODS: A stepped wedge cluster randomized control trial design was used to implement a standardized Stir-up Regimen in three PACUs in an academic hospital for adult patients who received at least 30 minutes of general anesthesia. The measured outcome was the PACU time in minutes from patient arrival to when the patient met Phase I discharge criteria. Differences between intervention and control groups were evaluated using a generalized mixed-effects model. Nurses were educated about the Stir-up Regimen in team huddles, in-services, video demonstrations, email notifications/reminders and reminders, and immediate feedback at the bedside. Implementation science principles were used to assess the adoption of the Stir-up Regimen through a presurvey, postsurvey and spot-check observations in all three PACUs.

FINDINGS: A total of 5,809 PACU adult patient admissions were included: control group (n = 2,860); intervention group (n = 2,949); males (n = 2,602), and females (n = 3,206). The intervention was associated with a reduction in overall mean Phase I recovery time of 4.9 minutes (95% CI: -8.4 to -1.4, P = .007). One PACU decreased time by 9.6 minutes (95% CI: -15.3 to -4.0, P < .001). The other units also reduced Phase I recovery time, but this did not reach statistical significance. The spot-check observations confirmed the intervention was adopted by the nurses, as most interventions were nurse-initiated versus patient-initiated during the first 30 minutes in PACU.

CONCLUSIONS: Standardization of a Stir-up Regimen within 30 minutes of patient PACU arrival resulted in decreased Phase I recovery time.

PMID:37978971 | DOI:10.1016/j.jopan.2023.07.014

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Determinants of adherence to treatment in patients with ophthalmic conditions

Expert Rev Clin Pharmacol. 2023 Nov 18:1-11. doi: 10.1080/17512433.2023.2279740. Online ahead of print.

ABSTRACT

BACKGROUND: The objective of this study was to identify and determine factors associated with patients’ ophthalmic adherence in common ocular conditions from randomized clinical trials (RCT).

RESEARCH DESIGN METHODS: A univariate analysis with proportions, a bivariate analysis using polychoric correlations, and logistic regression (LR) models were used. The collected dataset was made up of records from RCT. Using three validated LR models, factors were identified and ranked based on their adjusted odds ratio and their statistical significance to adherence.

RESULTS: A total of 1,087 valid patients were included in this analysis, of which 88.96% presented adherence. All models were calibrated, had a good performance, were well specified and cost-effective using the Hosmer-Lemeshow test, metrics for class imbalance, link test approach and Akaike’s criteriums, respectively.

CONCLUSION: We identified as determinants for encouraging good ophthalmic adherence the adverse events presented, duration of the study, female sex, and older age; other determinants such as medical condition, protocol treatment, type of treatment and disease are all risk factors for adherence. Improvements in ophthalmic adherence may be achieved by focused attention to young male patients with chronic degenerative diseases such as glaucoma or ocular hypertension (especially those who need combination therapy) and developing medications with reduced side effects.

PMID:37978952 | DOI:10.1080/17512433.2023.2279740

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BARRIERS AND ENABLERS OF INTERPROFESSIONAL COLLABORATION (IPC) AMONG HEALTH WORKERS IN A NIGERIAN TEACHING HOSPITAL

West Afr J Med. 2023 Nov 10;40(11 Suppl 1):S30.

ABSTRACT

INTRODUCTION: Interprofessional collaboration is crucial to the optimal functioning of every health system because the complex nature of healthcare requires that health workers from different allied professions work as a team to deliver quality health to the patients. Identifying the enhancing factors and barriers to this synergy is essential to safe and efficient healthcare delivery. This study addresses this issue in Nigeria, where inter-professional rivalry is rife.

OBJECTIVE: To determine the enablers of, and barriers to, interprofessional collaboration in Abubakar Tafawa Balewa University Teaching Hospital, Bauchi, Nigeria.

METHODOLOGY: The study adopted the proportionate stratified random sampling technique to recruit 266 staff of the hospital across the different health professions. Data was collected using an adapted version of the Assessment of Interprofessional Team Collaboration Scale (AITCS) and data analysis was done using the Statistical Package for Social Sciences version 23.0. The ideal scores pre-set were 4.0 for the enablers and 2.0 for the barriers. Ethical review for the study was obtained from the Ethics Review Committee of the hospital.

RESULTS: The mean score for the enablers was 4.28, and the strongest enabler of IPC identified was a climate of mutual respect, dignity, and trust among team members (4.36). On the other hand, the mean score for the barriers was 3.80, and the strongest barrier to IPC was the lack of role clarification (3.84).

CONCLUSION: The study revealed a strong level of enablers to IPC in ATBUTH. However, the barriers were above the set threshold, suggesting a significant impediment to IPC. The hospital should strengthen the identified enablers while making efforts to reduce the barriers. This type of study is also recommended for other hospitals in the country.

PMID:37978944

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In vivo assessment of black seed oil single dose on prednisolone pharmacokinetics

J Pharm Pharmacol. 2023 Nov 18:rgad110. doi: 10.1093/jpp/rgad110. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate the effect of blackseed oil (BSO) single dose on prednisolone pharmacokinetics via p-gp inhibition.

METHODS: Three groups of rats (n = 5) were orally administered the vehicle, verapamil (50 mg/kg) or BSO (5 ml/kg) 15 min prior to prednisolone (5 mg/kg) administration. Blood samples were collected over 24 h and quantified. Non-compartmental analysis was employed to calculate maximum plasma concentration (Cmax), area under the curve (AUC0-last), time to reach Cmax (Tmax), apparent clearance (CL/F), and half-life (t1/2). Statistical significance was considered at p<0.05.

RESULTS: Prednisolone Cmax and AUC0-last decreased by 65% and 25% in the BSO group compared to the negative control (P < .0001, .0029, respectively) while they increased by 1.75-folds and 8-folds in verapamil group (P < .0001). Tmax was achieved at 0.16, 0.5, and 0.25 h in the negative control, verapamil, and BSO-treated groups, respectively. CL/F in the treatment group was 1.3-fold and 10-fold higher compared to the negative and positive control, respectively, whereas the t1/2 remained comparable.

CONCLUSION: Administration of BSO decreased prednisolone Cmax and AUC0-last in rats indicating that there is a herb-drug interaction; however, p-gp inhibition cannot be concluded. Patients relying on folk medicine in chronic illnesses treatment might need to avoid combining BSO with prednisolone.

PMID:37978932 | DOI:10.1093/jpp/rgad110

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Expanding the reach of the trans-middle cerebellar peduncle approach: pontine cavernous malformations, tissue transgression beyond the safe entry zone, and the invisible triangle

J Neurosurg. 2023 Nov 17:1-13. doi: 10.3171/2023.8.JNS231684. Online ahead of print.

ABSTRACT

OBJECTIVE: In the authors’ microsurgical experience, the trans-middle cerebellar peduncle (MCP) approach to the lateral and central pons has been the most common approach to brainstem cavernous malformations (BSCMs). This approach through a well-tolerated safe entry zone (SEZ) allows a wide vertical or posterior trajectory, reaching pontine lesions extending into the midbrain, medulla, and pontine tegmentum. Better understanding of the relationships among lesion location, surgical trajectory, and long-term clinical outcomes could determine areas of safe passage.

METHODS: A single-surgeon cohort study of all primary trans-MCP BSCM resections was conducted from July 1, 2017, to June 30, 2021. Preoperative and postoperative MR images were independently reviewed by 3 investigators blinded to the intervention, using a standardized rubric to define BSCM regions of interest (ROIs) involved with a lesion or microsurgical tract. Statistical testing, including the chi-square test with the Bonferroni correction, logistic regression, and structural equation modeling, was performed to analyze relationships between ROIs and clinical outcomes.

RESULTS: Thirty-one patients underwent primary trans-MCP BSCM resection during the study period. The median age was 50 years (IQR 24-49 years); 19 (61%) patients were female, and 12 (39%) were male. Seven (23%) patients had familial cavernous malformation syndromes. The median follow-up was 9 months (range 6-37 months). At the last follow-up, composite neurological outcomes were favorable: 22 (71%) patients had 0 (n = 12, 39%) or 1 (n = 10, 32%) major persistent deficit, 5 patients (16%) had 2 deficits, 2 (7%) had 3 deficits, and 1 patient each (3%) had 4 or 6 deficits. Unfavorable composite outcomes were significantly associated with lesions (OR 7.14, p = 0.04) or surgical tracts (OR 12.18, p < 0.001) extending from the superior cerebellar peduncle (SCP) into the contralateral medial midbrain. The ipsilateral dorsal pons was the most frequently implicated ROI involving a surgical tract and the development of new postoperative deficits. This region involved the rhomboid pontine territory and transgression of the pontine tegmentum (OR 7.53, p < 0.001). Structural equation modeling supported medial midbrain and pontine tegmentum transgression as the primary drivers of morbidity.

CONCLUSIONS: Trans-MCP resection is a safe and effective treatment for BSCMs, including lesions with marked superior or inferior ipsilateral extension. Two trajectories are associated with increased neurological risk: first, a superomedial trajectory to lesions extending into the midbrain that transgresses the SCP, its decussation, or both; and second, a posteromedial trajectory to lesions extending into the pontine tegmentum. The corticospinal tract, SCP, and pontine tegmentum form an invisible triangle within the pontine white matter tolerant of transgression. When the surgeon works within this triangle, most deep pontine BSCMs, including large lesions, those with contralateral or posterior extension, and others extending into the midbrain and medulla, can be resected safely with the trans-MCP approach.

PMID:37976511 | DOI:10.3171/2023.8.JNS231684

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Safety and Efficacy of Intravenous ExoFlo in the Treatment of Complex Regional Pain Syndrome

Pain Physician. 2023 Nov;26(7):E851-E857.

ABSTRACT

BACKGROUND: Complex regional pain syndrome (CRPS) is an extremely painful disorder driven primarily by inflammation.

OBJECTIVES: We hypothesized that the immunomodulatory biologic, ExoFloTM, composed of bone marrow mesenchymal stem cell-derived extracellular vesicles, could be safely administered to CRPS patients and alleviate symptoms.

STUDY DESIGN: Ten patients received 2 intravenous (IV) infusions, each containing 15 mL ExoFlo, on day one and day 4. A series of tests were performed at baseline (day 0, prior to infusion), week one, and months one, 3, and 6 after the second infusion.

SETTING: All patients were treated in one of 2 outpatient pain management clinics in Orange County, CA.

METHODS: Testing for clinical improvement included: visual analog scale of pain, brief pain inventory, 36-item short-form questionnaire, range of motion analysis, and jamar dynamometer testing.

RESULTS: No serious adverse events related to ExoFlo treatment occurred. Statistically significant improvements in pain and motion assessments occurred across the patient pool.

LIMITATIONS: This study was limited by its patient number enrolled (10), it lacked a control arm, and one patient who dropped out of the study.

CONCLUSIONS: IV delivery of ExoFlo appears safe in patients with CRPS. In addition, ExoFlo exhibited efficacy in addressing CRPS symptoms. Given the lack of effective and safe treatments available to CRPS patients, these results suggest that further studies are warranted to explore and validate this potential treatment for CRPS.

PMID:37976492

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Comparison of Percutaneous Endoscopic Transforaminal and Interlaminar Approaches in Treating Adjacent Segment Disease Following Lumbar Decompression Surgery: A Clinical Retrospective Study

Pain Physician. 2023 Nov;26(7):E833-E842.

ABSTRACT

BACKGROUND: Adjacent segment disease (ASD) is a common complication following posterior disc decompression and fusion surgery. Percutaneous endoscopic lumbar decompression surgery (PELD) has been used to treat ASD through either a transforaminal or interlaminar approach. However, to our limited knowledge there are no reports comparing the 2 approaches for treating ASD.

OBJECTIVE: To evaluate clinical outcomes of PELD in treating ASD and comparing the surgical results and complications between the 2 approaches. This may be helpful for spinal surgeons when decision-making ASD treatment.

STUDY DESIGN: A clinical retrospective study.

SETTING: This study was conducted at the Department of Orthopedics of the Affiliated Hospital of Qingdao University.

METHODS: From January 2015 through December 2019, a total of 68 patients with ASD who underwent PELD after lumbar posterior decompression with fusion surgery were included in this study. The patients were divided into a percutaneous endoscopic transforaminal decompression (PETD) group and a percutaneous endoscopic interlaminar decompression (PEID) group according to the approach used. The demographic characteristics, radiographic and clinical outcomes, and complications were recorded in both groups through a chart review.

RESULTS: Of the 68 patients, 40 underwent PEID and 28 patients underwent PETD. Compared with their preoperative Visual Analog Scale (VAS) pain score and Oswestry Disability Index (ODI) score, all patients had significant postoperative improvement at 3 months, 6 months, one year and at the latest follow-up. There were no significant statistical differences in the VAS and ODI scores between PETD and PEID groups with a P value > 0.05. There was a significant statistical difference in the average fluoroscopy times between the PETD and PEID groups with a P value = 0.000. Revision surgery occurred in 8 patients: 6 patients who underwent PETD and 2 patients who underwent PEID. The revision rate showed a significant statistical difference between the 2 approaches with a P value = 0.039.

LIMITATIONS: Firstly, the number of patients included in this study was small. More patients are needed in a further study. Secondly, the follow-up time was limited in this study. There is still no conclusion about whether the primary decompression with instruments will increase the reoperation rate after a PELD, and a longer follow-up is needed in the future. Thirdly, this study was a clinical retrospective study. Randomized or controlled trials are needed in the future in order to achieve a higher level of evidence. Fourthly, there were debates about PELD approach choices for ASDs, which may affect the comparison results between PETD and PEID. In our study, the approaches were mainly determined by the level and types of disc herniation, and the surgeons’ preference. More patients with an ASD with different levels and types of disc herniation and surgical approaches are needed in the future to eliminate these biases.

CONCLUSION: Percutaneous endoscopic lumbar decompression surgery is a feasible option for ASD following lumbar decompression surgery with instruments. Compared with PETD, PEID seems to be a better approach to treat symptomatic ASDs.

PMID:37976490

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Efficacy and Complications of Percutaneous Balloon Compression for Patients With Trigeminal Neuralgia With and Without Concomitant Continuous Pain

Pain Physician. 2023 Nov;26(7):E823-E832.

ABSTRACT

BACKGROUND: Percutaneous balloon compression (PBC) has become one of the most common and effective minimally invasive treatments for trigeminal neuralgia (TN). However, the initial and long-term pain outcomes, as well as the complication rates of PBC for patients with TN with concomitant continuous pain (CCP) have yet to be specifically documented.

OBJECTIVE: In this clinical study, we aimed to evaluate and compare the results of PBC in treating TN with and without CCP.

STUDY DESIGN: Retrospective study.

METHODS: This research retrospectively analyzed the pain outcomes and complications of 57 patients with TN with CCP and 118 patients with TN without CCP who had undergone PBC at our institution from January 2019 through June 2022. Procedures were performed by one senior neurosurgeon in a single center. The postdischarge follow-up and the collection of clinical data, including immediate and long-term pain relief, time to recurrence, and complications, were completed through phone contact by an independent neurosurgeon blind to the patients’ information. Then, the results of the 2 groups were compared; demographic and clinical data were evaluated for possible predictive factors for poor pain outcomes.

RESULTS: In this study, PBC immediately resulted in complete pain relief in 70.2% of patients with CCP and significant pain relief in 84.2% of patients with CCP. For patients without CCP, the rates were 73.7% for complete pain relief and 85.6% for significant pain relief. After a minimum 6-month follow-up period, the rates decreased to 52.6% for complete pain relief and 73.7% for significant pain relief in patients with CCP, compared to 54.2% and 75.4% in those without CCP. The initial and long-term pain control rates in patients without CCP were slightly higher than those with CCP, but the differences were not statistically significant (P = 0.878, P = 0.968, respectively). The incidences of postoperative complications were similar between patients with and without CCP (21.1% vs 22.0%, P = 0.883), whereas the remission rate of complications in patients with CCP was significantly lower than that in patients without CCP (25.0% vs 69.2%, P = 0.011). A longer symptoms duration and having a history of neurodestructive procedures were predictive factors for poor outcomes following PBC.

LIMITATIONS: The study was performed in a single-center. The nature of this research is retrospective instead of prospective and randomized, with the inability to control completely for variables. Additionally, the follow-up duration was not long enough to observe recurrence in some patients.

CONCLUSIONS: This is the first specifically reported experience treating TN with CCP with PBC. PBC can result in significant relief of both episodic and constant pain from TN with CCP. Patients with a longer duration of pain and prior neurodestructive procedures have a higher risk of poor outcomes. The presence of CCP is not associated with pain outcomes and should not be considered a contraindication to PBC.

PMID:37976489

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Effect of Ultrasound-Guided Rhomboid Interfascial Plane Block on Pain Severity, Disability, and Quality of Life in Myofascial Pain Syndrome – A Case Series With One-Year Follow-Up

Pain Physician. 2023 Nov;26(7):E815-E822.

ABSTRACT

BACKGROUND: Myofascial pain syndrome (MPS) is a condition characterized by trigger points in the taut bands of skeletal muscles, commonly affecting the trapezius, rhomboid, and supraspinatus muscles. Rhomboid intercostal block (RIB), an interfascial plane block used to assist perioperative analgesia might be a potential treatment option in MPS.

OBJECTIVES: To investigate the short and long-term effects of ultrasound-guided RIB in reducing the severity of pain, disability, and improving quality of life in MPS patients with trigger points in the rhomboid muscle.

STUDY DESIGN: Retrospective study.

SETTING: Physical medicine and rehabilitation outpatient clinic in a university hospital.

METHODS: Patients with a diagnosis of MPS who received ultrasound (US)-guided RIB between November 2021 and January 2022 were enrolled in this study. All patients reported pain lasting >= 3 months and severity >= 4/10 on numeric rating scale (NRS), without any comorbidities affecting the neuromuscular system. Trigger points in the rhomboid muscle were treated with US-guided RIB. Pain intensity was evaluated using a NRS at pre-treatment and one week, one month and one year after the injection. At pre-treatment, one month, and one year after treatment, self-administered neck pain and disability scale and Nottingham Health Profile were evaluated.

RESULTS: A total of 23 patients were included in this study (5 men and 18 women, with an average age of 45). Pain severity was statistically significantly reduced in approximately 90%, 60-70%, and 50% of the chronic MPS patients at the first week, first month, and first year following injection, respectively. Disability scores improved significantly in 70% and 56% of those patients at the first month and first-year follow-up. Improvement in the quality of life was observed at the first month and maintained at the first-year follow-up.

LIMITATIONS: The retrospective design of this study is a limitation. Due to the lack of a control group, this treatment option could not be compared with other treatments.

CONCLUSIONS: Our study demonstrated that RIB might be an effective long-term treatment option for MPS in the reduction of pain and disability, improvement of quality of life and overall patient satisfaction.

PMID:37976488

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Results From a Prospective, Clinical Study (US-nPower) Evaluating a Miniature Spinal Cord Stimulator for the Management of Chronic, Intractable Pain

Pain Physician. 2023 Nov;26(7):575-584.

ABSTRACT

BACKGROUND: Chronic, intractable, neuropathic pain is readily treatable with spinal cord stimulation (SCS). Technological advancements, including device miniaturization, are advancing the field of neuromodulation.

OBJECTIVES: We report here the results of an SCS clinical trial to treat chronic, low back and leg pain, with a micro-implantable pulse generator (micro-IPG).

STUDY DESIGN: This was a single-arm, prospective, multicenter, postmarket, observational study.

SETTING: Patients were recruited from 15 US-based comprehensive pain centers.

METHODS: This open-label clinical trial was designed to evaluate the performance of the Nalu™ Neurostimulation System (Nalu Medical, Inc., Carlsbad, CA) in the treatment of low back and leg pain. Patients, who provided informed consent and were successfully screened for study entry, were implanted with temporary trial leads. Patients went on to receive a permanent implant of the leads and micro-IPG if they demonstrated a >= 50% reduction in pain during the temporary trial period. Patient-reported outcomes (PROs), such as pain scores, functional disability, mood, patient impression of change, comfort, therapy use profile, and device ease of use, were captured.

RESULTS: At baseline, the average pain Visual Analog Scale (VAS) score was 72.1 ± 17.9 in the leg and 78.0 ± 15.4 in the low back. At 90 days following permanent implant (end of study), pain scores improved by 76% (VAS 18.5 ± 18.8) in the leg and 75% (VAS 19.7 ± 20.8) in the low back. Eighty-six percent of both leg pain and low back pain patients demonstrated a >= 50% reduction in pain at 90 days following implant. The comfort of the external wearable (Therapy Disc and Adhesive Clip) was rated 1.16 ± 1.53, on average, at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). All PROs demonstrated statistically significant symptomatic improvement at 90 days following implant of the micro-IPG.

LIMITATIONS: Limitations of this study include the lack of long-term results (beyond 90 days) and a relatively small sample size of 35 patients who were part of the analysis; additionally, there was no control arm or randomization as this was a single-arm study, without a comparator, designed to document the efficacy and safety of the device. Therefore, no direct comparisons to other SCS systems were possible.

CONCLUSIONS: This clinical study demonstrated profound leg and low back pain relief in terms of overall pain reduction, as well as the proportion of therapy responders. The study patients reported the wearable aspects of the system to be very comfortable.

PMID:37976486