Results of the early and mid-term postoperative period after correction of total anomalous pulmonary venous connection

<p><strong>Aim.</strong> To compare complications and outcomes in the postoperative period with two different methods for correcting total anomalous pulmonary venous connection.</p><p><strong>Methods. </strong>In this pilot, two-centre, simple, blind, prospective randomised study, the patients’ quality of life after correction of total anomalous pulmonary venous connection in infancy was evaluated using the sutureless (n = 20) and conventional repair methods (n = 20) in 40 patients. The overall mortality and complications in the mid-term were evaluated.</p><p><strong>Results.</strong> The average follow-up was 15 (13; 16) months. Mortality was noted only in the conventional repair group, amounting to 5 (25%) patients (p = 0.018). Severe obstruction of the pulmonary veins anastomosis was also noted only in the conventional repair group (n = 8, 40%; p = 0.0013). Infectious endocarditis was observed in one (6.6%) patient in the conventional repair group (p = 0.42). Arrhythmias were present in 4 (26.6%) patients in the conventional repair group (p = 0.02).</p><p><strong>Conclusion.</strong> The rates of obstruction of the pulmonary vein anastomosis, arrhythmias and death depend on the method of total anomalous pulmonary venous connection correction. The sutureless repair reduces the incidence of early and mid-term postoperative complications compared to conventional repair.</p><p>Received 16 March 2021. Revised 8 June 2021. Accepted 11 June 2021.</p><p><strong>Funding:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest:</strong> The authors declare no conflict of interest.</p><p><strong>Contribution of the authors<br /> </strong>Conception and study design: Yu.N. Gorbatykh, A.V. Bogachev-Prokophiev, M.V. Plotnikov<br /> Data collection and analysis: M.V. Plotnikov, M.G. Galstyan, D.G. Tarasov<br /> Statistical analysis: M.V. Plotnikov<br /> Drafting the article: M.V. Plotnikov, Yu.N. Gorbatykh<br /> Critical revision of the article: I.A. Soynov<br /> Final approval of the version to be published: M.V. Plotnikov, Yu.N. Gorbatykh, A.N. Аrkhipov, M.G. Galstyan, A.V. Bogachev-Prokophiev, D.G. Tarasov, I.A. Soynov</p>

Comparative Randomised Study between Bupivacaine with Clonidine and Ropivacaine with Clonidine Used Caudally for Postopertaive Analgesia in Paediatric Hypospadias Surgery

Background: This study was conducted to compare and evaluate the caudal epidural clonidine when mixed with ropivacaine and bupivacaine in prolonging postoperative analgesia in children of Indian genotype undergoing hypospadias surgery, as well as compare the intraoperative haemodynamics using caudal bupivacaine with clonidine vs ropivacaine with clonidine. The study was also aimed at studying the side effects and the duration of post-operative pain relief of bupivacaine with clonidine v/s ropivacaine with clonidine. Methods: This is a prospective randomised comparative study that was carried out in the Department of Anaesthesiology, KEM Hospital, Pune, over 12 months (from October 2016 to September 2017), among 56 children having an ASA Grade of II, aged between 1 to 8 years admitted for hypospadias surgery. The data gathered was cleaned using Microsoft Excel, before statistical analysis was done. Results: It was observed that caudal epidural analgesic duration was more in the bupivacaine clonidine group than in the ropivacaine clonidine group. The sedation score was higher at the second hour in the bupivacaine clonidine group. The HR and mean arterial pressure values were found to be notably higher in the ropivacaine clonidine group than those in the bupivacaine clonidine group. Intraoperatively and postoperatively, there was a decrease in pulse rate and MAP but at no time did the value reach the criteria for intervention. Other side effects like postoperative vomiting, nausea, motor blockade, respiratory distress not observed in any group. Conclusion: Bupivacaine 0.25 % 0.5 ml per kg with clonidine 1 microgram / kg via caudal route increased the duration of postoperative analgesia with no adverse effects as compared to ropivacaine 0.25 % with clonidine 1 microgram/ kg. Hence clonidine is more efficient in increasing postoperative analgesia when added with Bupivacaine as compared to ropivacaine in Indian genotype in hypospadias surgery.

Two-step versus 1-step subretinal injection to compare subretinal drug delivery: a randomised study protocol

IntroductionThere is increasing interest in subretinal injections as a surgical procedure, largely as a result of emerging treatments for ocular diseases which necessitate this manoeuvre. However, surgical variables in the efficacy of such treatments have to date been largely overlooked and the proportion of drug which reaches the intended compartment of the subretinal space remains unknown. Our aims are twofold: first, to determine the proportion of subretinally injected medication retained following surgical delivery and second, to compare two different techniques of injection (‘1-step’ vs ‘2-step’).MethodsWe outline a randomised controlled trial of subretinal injection of alteplase following vitrectomy for the management of submacular haemorrhage secondary to age-related macular degeneration. Patients will be randomised to receive either 1-step injection, where the therapeutic solution simultaneously defines the surgical plane or 2-step injection, where the surgical plane is first identified with balanced salt solution prior to injection of subretinal alteplase, as outlined below. Sodium fluorescein will be used as an optical label to track drug reflux into the vitreous cavity using quantitative protocols established in our laboratory. All patients will undergo fluid air exchange at the completion of surgery, with injection of bevacizumab 1.25 mg and 20% sulfahexafluoride gas as the vitreous substitute (both of which may help improve outcomes). Alteplase, sodium fluorescein and bevacizumab will all be used for off-label indications in the trial.Ethics and disseminationEthical approval has been obtained from the South Eastern Sydney Local Health District’s Human Research Ethics Committee (HREC 17/092). The results of this trial will be disseminated in peer-reviewed proceedings (associated with conference presentation) and in scholarly journals.Trial registration numberACTRN12619001121156.

Protocol for Exploring Effective Clinical Governance Strategies in South Africa’s Eastern Cape and Mpumalanga Provinces

Background: Hospitals are an integral part of the national health system. They provide a hub for health services that cannot be provided in the primary care setting, provide facilities for advanced investigation, diagnosis, and treatment, and constitute the platform for training and development of health professionals. However, when inspections were done at public sector facilities in preparation for the implementation of the NHI, the lowest average performance score was in leadership and corporate governance. This study aims to assess the effectiveness of clinical governance interventions in selected public hospitals in South Africa’s Eastern Cape and Mpumalanga provinces. Methods: This will be a cluster randomised study where there will be two intervention sites (a tertiary hospital and a regional hospital) and control sites (non-intervention central and regional hospitals). The intervention will comprise a focused implementation of clinical governance protocols (through training and coaching of hospital management and frontline health workers). There will be a pre-intervention baseline assessment; an assessment immediately at the end of the 12 months long intervention and an assessment at 36 months post-intervention. This builds on existing policy initiatives, quality improvement initiatives and tools. Information will be sourced through six sub-studies – three qualitative and three quantitative. Ethical clearance with reference number: 040/21 has been granted by the Research Ethics Committee of the Faculty of Health Sciences at Walter Sisulu University. Approvals to access the research sites with refence numbers: EC_202106_019 and MP_202106_009 have been granted by the Eastern Cape and Mpumalanga Provincial Health Research Committees respectively.Discussion: There is a need for a deeper understanding of how tertiary and regional hospitals operate, how these hospitals ensure provision of safe high-quality patient-centred clinical care and factors enabling them or hindering them from achieving higher performance. In addition, it is necessary to explore if the performance of the hospitals improves where there is a focused implementation of clinical governance protocols.

The Effects of Nusinersen Treatment on Respiratuar Status of Children with Spinal Muscular Atrophy

Introduction : Pulmonary involvement is the main prognostic factor in children with spinal muscular atrophy (SMA). Nusinersen, a new treatment modality, is being evaluated in recent studies, although the respiratory part has not yet been clarified. We aimed to reveal the effects of nusinersen on the respiratory functions of patients with spinal muscular atrophy (SMA). Methods : In this single-center randomised study, conducted between June 2020/July 2021, patients with SMA were evaluated before and during nusinersen therapy. Data were collected on respiratory status, nutritional support, motor involvement, and other comorbidities that may affect the disease prognosis. Results : Patients with the number of 43 (18 type1, 12 type2, 13 type3) with a mean age of diagnosis of 10 months (range 1.5-192) and 24 months (3-219) at the start of nusinersen therapy were included. An improvement in respiratory status was noted in six patients between the second and third assessment. SMN2 copy numbers were significantly associated with better prognosis. Early initiation of nusinersen was significantly correlated with reduced hospital admissions. Nutritional support and weight gain were remarkable in the ventilatory supported group. A significant improvement was observed in motor functions, and chop-intend scores were statistically significantly higher in non-tracheostomized group (p<0.005). Conclusion : We think that nusinersen’s effect may be significant with early initiation and continuation of treatment. Improvements in respiratory functions noted in our study require to be supported with future long-term studies considering the overall genetic and environmental status, even the cost-effectiveness,to make a global consensus on nusinersen therapy.

Supraclavicular block with Mepivacaine vs Ropivacaine, their impact on postoperative pain: a prospective randomised study

Background Supraclavicular block (SCB) with long-acting local anaesthetic is commonly used for surgical repair of distal radial fractures (DRF). Studies have shown a risk for rebound pain when the block fades. This randomised single-centre study aimed to compare pain and opioid consumption the first three days post-surgery between SCB-mepivacaine vs. SCB-ropivacaine, with general anaesthesia (GA) as control. Methods Patients (n = 90) with ASA physical status 1–3 were prospectively randomised to receive; SCB with mepivacine 1%, 25–30 ml (n = 30), SCB with ropivacaine 0.5%, 25–30 ml (n = 30) or GA (n = 30) with propofol/fentanyl/sevoflurane. Study objectives compared postoperative pain with Numeric Rating Scale (NRS) and sum postoperative Opioid Equivalent Consumption (OEC) during the first 3 days post-surgery between study-groups. Results The three groups showed significant differences in postoperative pain-profile. Mean NRS at 24 h was significantly lower for the SCB-mepivacaine group (p = 0.018). Further both median NRS and median OEC day 0 to 3 were significanly lower in the SCB-mepivacaine group as compared to the SCB-ropivacaine group during the first three days after surgery; pain NRS 1 (IQR 0.3–3.3) and 2.7 (IQR 1.3–4.2) (p = 0.017) and OEC 30 mg (IQR 10–80) and 85 mg (IQR 45–125) (p = 0.004), respectively. The GA-group was in between both in pain NRS and median sum OEC. Unplanned healthcare contacts were highest among SCB-ropivacaine patients (39.3%) vs. SCB-mepivacaine patients (0%) and GA-patients (3.4%). Conclusions The potential benefit of longer duration of analgesia, associated to a long-acting local anaesthetic agent, during the early postoperative course must be put in perspective of potential worse pain progression following block resolution. Trial registration NCT03749174 (clinicaltrials.gov, Nov 21, 2018, retrospectively registered).