Randomized Clinical Trial Study Research Articles

Comparison Effect of Clonidine and Magnesium Sulfate on Bleeding Volume during Septorhinoplasty: A Double-Blind, Randomized Clinical Trial

Background: Control of hemodynamic changes and blood loss is a daily challenge in general anesthesia for patients undergoing septorhinoplasty. This study aimed to evaluate the effects of magnesium sulfate and clonidine on the control of hemodynamic factors and bleeding volume during this procedure. Methods: This double-blind, randomized clinical trial study was conducted on 60 patients undergoing septorhinoplasty at 5th Azar Medical & Educational Centre of Gorgan in 2021-2022. Patients were divided into two intervention groups (50 mg/kg of magnesium sulfate) and control group (5 μg/kg of clonidine) with permutation random block allocation. All patients underwent induced hypotension. Before induction of anesthesia and every 5 minutes afterwards, blood pressure was recorded. Blood loss volume was calculated at the end of the surgery. Results: In the magnesium group, 36 individuals were evaluated, while in the clonidine group, 24 individuals were examined. There were no statistically significant differences in baseline characteristics of patients in the two groups and the duration of surgery. Both drugs were equally effective in inducing hypotension, however blood pressure changes in magnesium group were more trivial than clonidine group. The bleeding volume in the magnesium sulfate and clonidine groups was 139.44 ml and 141.25, respectively and this difference was not statistically significant (p-value=0.634). Conclusion: The results of this study showed that magnesium sulfate can be effectively used as an alternative to clonidine in controlling hemodynamic changes and ultimately reducing blood loss volume during septorhinoplasty surgery. In addition, magnesium is at least as effective as clonidine in stabilizing hemodynamic changes.

The Effect of Lifestyle Interventions on Anxiety, Depression and Stress: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Depression, anxiety, and stress are common mental health issues that affect individuals worldwide. This systematic review and meta-analysis examined the effectiveness of various lifestyle interventions including physical activity, dietary changes, and sleep hygiene in reducing the symptoms of depression, anxiety, and stress. Using stress as an outcome and conducting detailed subgroup analyses, this study provides novel insights into the differential effects of lifestyle interventions across diverse populations. Five databases were systematically searched: PubMed, Web of Science, Scopus, Cochrane Library, and Google Scholar, for gray literature searches. Keywords were used to search each database. The search period was from the conception of the databases until August 2023 and was conducted in English. For each analysis, Hedges' g was reported with a 95% confidence interval (CI) based on the random-effects method. Subgroups were analyzed and heterogeneity and publication bias were examined. Ninety-six randomized clinical trial studies were included in this meta-analysis. Lifestyle interventions reduced depression (Hedges g -0.21, 95% confidence interval -0.26, -0.15; p < 0.001; I2 = 56.57), anxiety (Hedges g -0.24, 95% confidence interval -0.32, -0.15; p < 0.001; I2 = 59.25), and stress (-0.34, -0.11; p < 0.001; I2 = 61.40). Lifestyle interventions offer a more accessible and cost-effective alternative to traditional treatments and provide targeted benefits for different psychological symptoms.

The effect of eight weeks’feedback training program on lower extremity kinematic and performance during jump landing tasks in the men with selected motor control defects

Introduction and objectiveThe present study aims to investigate whether eight weeks’ feedback improves the range of motion in lower extremity joints(in the four phases of eccentric, concentric, maximum knee flexion, and landing moment) and performance in the individuals with motor control defects or not. MethodThe present research is a randomized clinical trial study before and after the intervention. Thirty-four male recreational athletes with movement control defects were selected based on the study criteria and then randomly assigned to a control group and an intervention group. Kinematic and performance data were recorded while the participants performed jump-landing movement tasks in two stages before and after the two-month jump training program. To analyze the data, the two-way analysis of variance and Bonferroni statistical tests were used for each movement task at the significance level of P < 0.05. FindingsThere was a significant difference between the values of Reactive Strength Index (RSI) in the intervention and the control groups in drop vertical jumps and countermovement jumps (p = 0.001). ConclusionThe results of the present study indicated that two months' feedback improved the athletes’ kinematic variables and jumping performance.

The comparison of efficacy of Escitalopram and Bupropion in treatment of depression symptoms in patients with heart failure: randomized clinical trial.

This study aims to compare the effects of two medicines, Escitalopram and Bupropion, on HF patients who have depression symptoms. This double-blind randomized clinical trial study was conducted on HF patients with depression symptoms at the Heart Failure Clinics affiliated with Babol University of Medical Sciences. In this study, 80 participants were examined for depression based on the Beck Depression Inventory (BDI) and Hamilton Depression Rating Scale (HDRS). They were randomly allocated into two groups of 40 participants treated with Bupropion 75mg and Escitalopram 5mg. Following the intervention, the individuals were assessed in terms of their depression score at 4, 8, and 12-week intervals. Finally, the data were analyzed using SPSS version 22.0. In the examination of Beck and Hamilton scores in the two research groups during different follow-ups, a significant decrease was found over time (P<0.001 for both medicines). While the effectiveness of the two medicines was the same at different times (P>0.05 in all cases). Comparing the side effects between the two intervention groups, the orgasm disorder (P=0.018) and sexual dysfunction (P<0.001) were reported significantly more in the Escitalopram group than in the Bupropion group. The findings of this study showed that Escitalopram has the same efficacy as Bupropion in the treatment of depression symptoms in HF patients.

Implementation of sodium-glucose co-transporter 2 inhibitors in patients with heart failure through a new digital strategy (EMAIL-HF): a randomised clinical trial study design

Abstract Introduction Delayed implementation of new medical discoveries remains a global healthcare challenge and is mainly due to the complexity of cross-institutional patient care. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors is the latest medical discovery in heart failure (HF) and have recently been added to clinical guidelines as they have proven to reduce the risk of adverse cardiovascular outcomes in patients with HF across the ejection fraction spectrum. Whether a new digital strategy can optimise and accelerate the implementation of SGLT2 inhibitors in patients living with HF is of great importance for public health. Purpose To evaluate whether a new and streamlined digital strategy can optimise and accelerate the implementation of SGLT2 inhibitors in patients with HF. Design and methods: The trial is a multicentre, parallel group, register-based randomised clinical study, evaluating the effect and potential of a new digital strategy to implement new guideline therapies to patients living with a chronic disease, specifically SGLT2 inhibitors to patients with HF (figure 1). The setup employs data from nationwide health registers and official digital letters to inform patients about the new therapy option and invite them to have their eligibility evaluated by a HF specialist and start therapy. A total of ~10,000 patients with HF across the ejection fraction spectrum (with and without diabetes), who have not yet been started on SGLT2 inhibitors, are identified through Danish nationwide health registers, and randomised 1:1 to receive the digital letter (figure 2). The primary outcome is the proportion of patients redeeming a prescription of a SGLT2 inhibitor within six months. Secondary outcome is a composite HF endpoint consisting of all-cause death or HF hospitalisation. Other outcome measures are renal failure, stroke and myocardial infarction, safety outcomes, adherence to therapy and proportion of vulnerable patient groups initiating therapy including immigrants, elderly, frail patients, patients with lower socioeconomic level and lower educational level. A total of 4689 patients have been randomised (February 2024) and data will be presented in 2025. Conclusions The trial will determine the efficacy and safety of a new and streamlined digital strategy to implement SGLT2 inhibitors to patients with chronic HF. The setup has the potential to be used in a broad spectrum of patients living with chronic diseases and is expected to be highly cost-effective.Figure 1.Study hypothesisFigure 2.Study design

Effect of prophylactic infusion of norepinephrine on the prevention of hypotension during vertebroplasty: a randomized clinical trial

BackgroundTransient hypotension is a common occurrence during the implantation of bone cement. This placebo-controlled randomized clinical trial study investigated the effect of prophylactic infusion of norepinephrine on the incidence of hypotension in senior patients who underwent vertebroplasty.MethodsThe trial recruited patients who were greater than or equal to 65 years of age, had an American Society of Anesthesiologist physical status classification of I to III, and underwent vertebroplasty from August 2020 to August 2021 at the Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine in China. The patients were randomly grouped according to whether they received either a norepinephrine infusion of 0.05 µg/kg/min or an equivalent volume of saline 10 min before implantation of bone cement. Intraoperative hemodynamics were monitored continuously by the MostCare system at the following 7 time points: 10 min before implantation of bone cement and immediately, 30 s, 1, 3, 5, and 10 min after implantation of bone cement. We also recorded the number of hypotensive episodes and the total number of vasopressors after implantation of bone cement. Multivariable logistic regression was used to assess the risk factors associated with hypotension after implantation of bone cement.ResultsA total of 63 patients were randomized to the control group (n = 31; median [IQR] age, 74 [69–79] years) and the norepinephrine group (n = 32; median [IQR] age, 75 [71–79] years). The incidence of hypotension in the norepinephrine group was significantly lower than that in the control group after implantation of bone cement (12.5% vs. 45.2%; relative risk [RR], 3.61 [95% CI, 1.13–15.07]; P = 0.005). Moreover, the median (IQR) number of hypotensive episodes (0 [0–0] vs. 0 [0–2]; P = 0.005) and the total number of vasopressors (0 [0–0] vs. 0 [0–1]; P = 0.004) in the norepinephrine group were significantly lower than those in the control group. Furthermore, compared with the baseline, the MAP significantly decreased at 1 min (P = 0.007) and 3 min (P < 0.001) after bone cement implantation in the control group. However, the MAP at 3 min in the norepinephrine group was significantly higher than that in the control group (P < 0.001). The incidence of complications was not different between the groups. In multivariable logistic regression, the FRAIL score (OR, 2.29; 95% CI, 1.21–4.31) was identified as a risk factor associated with hypotension.ConclusionProphylactic infusion of norepinephrine before bone cement implantation can stabilize hemodynamics and reduce the incidence of hypotension after implantation of bone cement.

Tissue Plasminogen Activator or Perfluoropropane for Submacular Hemorrhage in Age-Related Macular Degeneration

Evidence is limited to support therapies to treat submacular hemorrhage (SMH) secondary to neovascular age-related macular degeneration (AMD) as an adjunct to anti-vascular endothelial growth factor therapy (anti-VEGF). To determine if intravitreal tissue plasminogen activator (TPA) or gas improves visual acuity or promotes resolution of SMH secondary to neovascular AMD in eyes treated with ranibizumab. This was a double-masked, sham-controlled, factorial randomized clinical trial and feasibility study that recruited participants from June 2014 to March 2019, with 12 months' follow-up. Included in the trial were patients from 4 UK vitreoretinal units who had fovea-involving SMH of at least 1 disc area secondary to neovascular AMD and were evaluated within 14 days of onset. Study eyes received baseline ranibizumab and were then randomized 2:1:1:1 to 1 of 4 intravitreal treatments: sham injection, perfluoropropane (C3F8), TPA, or combined C3F8 and TPA (C3F8 + TPA). All eyes received monthly pro re nata ranibizumab therapy over 12 months. Outcome assessors were masked to intervention assignment. Best-corrected visual acuity (BCVA) at month 3. Fifty-three of 56 participants (95%; mean [SD] age, 81.5 [8.1] years; 33 female [59%]) reached the primary end point. Study eyes were randomized to the following intravitreal treatments: sham injection (n = 23), C3F8 (n = 11), TPA (n = 11), or C3F8 + TPA (n = 11). On factorial analysis, the combined TPA groups had significantly better month 3 mean logMAR BCVA than those not receiving TPA: 0.66 vs 0.98 (μd = -0.32; 95% CI, -0.58 to -0.07; P = .02). There was no statistically significant difference comparing groups that did vs did not receive C3F8: 0.80 vs 0.90 (μd = -0.11; 95% CI, -0.37 to 0.16; P = .43). The combined TPA groups were less likely to have SMH present at month 1 (10 of 18 [55.6%] vs 21 of 24 [87.5%]; P = .03), a benefit not evident in the combined gas groups. The mean logMAR BCVA at 3 months was not significantly different between the groups: monotherapy control, 0.99; C3F8, 0.97 (vs control μd = -0.02; 95% CI, -0.48 to 0.44); TPA, 0.70 (vs control μd = -0.29; 95% CI, -0.79 to 0.21); combined C3F8 and TPA, 0.71 (vs control μd = -0.36; 95% CI, -0.82 to 0.11); P = .11. No safety differences were identified across the treatment groups. Results of this randomized clinical trial suggest that TPA may increase the chance of visual acuity gain when added to ranibizumab therapy for neovascular AMD in eyes with SMH, warranting consideration of additional clinical trials. ClinicalTrials.gov Identifier: NCT01835067.

The impact of antioxidants on antioxidant capacity, DNA fragmentation, and chromatin quality in subfertile men: a randomized clinical trial study.

This randomized clinical trial study aims to investigate the effects of antioxidant food supplementation on the total antioxidant capacity of seminal plasma, sperm DNA fragmentation, sperm chromatin quality, and semen parameters. In this study, a total of 48 subfertile men with moderate physical activity were included. Group 1 was recommended to use the antioxidant supplements, while antioxidant food supplements were not given to Group 2. Total antioxidant capacity, sperm DNA fragmentation, sperm chromatin structure, hormone levels, physical activities, and semen parameters were evaluated before and after treatment. Total antioxidant capacity, sperm DNA fragmentation, and sperm chromatin structure were assessed using ELISA, transferase dUTP nick end labeling, and aniline blue staining, respectively. Sperm DNA fragmentation (p=0.003) and histone/protamine ratio (p<0.001) were significantly decreased in the patients receiving antioxidant treatment. There was no statistical difference in the total antioxidant capacity values of the post-treatment groups. Antioxidant therapy seems to improve sperm DNA fragmentation and histone/protamine ratios in subfertile patients. NCT06042738.

Ultrasound-Guided Quadratus Lumborum Block Using Bupivacaine versus Bupivacaine–Magnesium Sulfate as Postoperative Analgesia in Open Appendectomy in Middle Age Group

Abstract Background The QLB is an effective analgesic technique for various abdominal wall incisions. The QLB covers T7 to L1 dermatomes by the spread of LA drugs either into the paravertebral space or in the thoracolumbar plane, through iliohypogastric and ilioinguinal nerves, A and C fiber nociceptors, mechanoreceptors and high-density network of lumbar sympathetic fibers. Objective To assess the analgesic sparing effect of adding magnesium sulfate to Bupivacaine in Quadratus lumborum block in patients undergoing open appendectomy under general anesthesia. Patients and Methods After approval of the anaesthesiology department and scientific and ethical committees, this prospective single blind randomized clinical trial study was conducted in Ain Shams University Hospitals. Sixty patients scheduled for open appendectomy under general anaesthesia were included in this study. Patients were randomized using a random number table and the use of a closed envelopes technique to receive quadratus lumborum either magnesium sulphate and bupivacaine or bupivacaine only, each group constitutes of 30 patients. Results We found that the addition of magnesium sulfate to bupivacaine in QLB in open appendectomy in middle age group provides a prolonged duration of postoperative analgesia, with reduced analgesic requirements, a better quality of analgesia in terms of NRS compared to bupivacaine alone group. Conclusion The addition of magnesium sulfate to Bupivacaine in lateral QLB in open appendectomy surgery provides a prolonged duration of postoperative analgesia, with reduced analgesic requirements, a better quality of analgesia in terms of NRS compared to bupivacaine alone group.

Surgical outcomes of neoadjuvant endocrine treatment in early breast cancer: meta-analysis.

Neoadjuvant endocrine therapy presents an important downstaging option with lower toxicity than neoadjuvant chemotherapy in oestrogen receptor (ER)-positive early breast cancer. Meta-analysis of the effects of neoadjuvant endocrine therapy on surgical outcomes across randomized clinical trials (RCTs) and cohort studies has not previously been performed. A systematic review and meta-analysis was performed to evaluate the effect of neoadjuvant endocrine therapy on surgical outcomes (PROSPERO (international prospective register of systematic reviews, 2020)) compared with surgery followed by adjuvant endocrine therapy. PubMed and EMBASE were searched to identify RCT and cohort studies between 1946 and 27 March 2024. Two independent reviewers manually screened the identified records and extracted the data. Risk of bias was assessed using the Cochrane Collaboration tools and random-effects meta-analysis was done with ReviewManager. The search identified 2390 articles eligible for screening. The review included 20 studies (12 cohort and 8 RCTs); 19 were included in the meta-analysis with a total of 6382 patients. Overall, neoadjuvant endocrine therapy was associated with a lower mastectomy rate compared with surgery first (risk ratio (RR) 0.53, 95% c.i. 0.44 to 0.64). Subgroup analysis showed similar improvement in the mastectomy rate in the neoadjuvant endocrine therapy group versus control group irrespective of study type (RCT: RR 0.58, 95% c.i. 0.50 to 0.66; cohorts: RR 0.48, 95% c.i. 0.33 to 0.70). There was no difference in the mastectomy rate by duration of neoadjuvant endocrine therapy (more than 4 months: RR 0.57, 95% c.i. 0.42 to 0.78; 4 months or less than 4 months: RR 0.52, 95% c.i. 0.43 to 0.64). Most of the studies were characterized by moderate-quality evidence with significant heterogeneity. Neoadjuvant endocrine therapy is associated with a reduction in mastectomy rate. Given the moderate methodological quality of previous studies, further RCTs are required. CRD42020209257.

Effect of silymarin on lipid profile and glycemic control in patients with type 2 diabetes mellitus.

This randomized clinical trial was conducted to evaluate the effects of silymarin supplementation on glycemic indices and serum lipid profile in type 2 diabetes mellitus (T2DM) patients. In this open-label randomized clinical trial study, 48 patients with T2DM were eligible to participate for 12 weeks and were divided into two groups randomly: 24 subjects in the intervention (received three 140 mg silymarin capsules daily and diet plan) and 24 in control (received a diet plan). Fasting blood samples and anthropometric data were collected, and glycemic indices and lipid profiles were determined at baseline and at the end of the study. Out of 60 patients included in the clinical trial, 48 people completed the study. In comparing silymarin and control groups before and after the study, a significant reduction was observed in weight and body mass index. However, after adjustment, no significant difference was seen between the two groups. Furthermore, daily consumption of three capsules of 140 mg silymarin for 12 weeks did not show any significant difference on the level of fasting blood sugar (p = 0.789), HbA1c (p = 0.719), and lipid profile. The findings of the present study show that silymarin did not lead to changes in the level of glycemic index and lipid profile in patients with T2DM.

Comparison of the effect of dydrogesterone and natural micronized progesterone for luteal-phase support in assisted reproductive technology cycles: A single-blind randomized clinical trial study.

One of the causes of preterm labor and recurrent abortion is progesterone deficiency in the luteal phase. The aim of the study was a comparison of the effect of oral dydrogesterone and vaginal progesterone for luteal-phase support (LPS) in assisted reproductive technology cycles (ART). This randomized clinical control trial study was conducted on 207 infertile women. Samples were randomly divided into two groups. The first group received a natural micronized vaginal progesterone (MVP) of 400 mg once daily and the second group received dydrogesterone (Duphestone) 20 mg twice daily. Then chemical pregnancy, abortion, and live births were compared in two groups. The results of the study showed that the vaginal form of the drug could increase the chance of pregnancy (positive β-human chorionic gonadotropin) versus the oral form. According to the results of multiple logistic regression analysis after adjusting for other variables, the live birth rate in the vaginal group was more than five times that of the oral group (odds ratio = 5.07; 95% confidence interval = 1.24-20.65; p = 0.023). The vaginal form of the progesterone could increase the chance of pregnancy and the outcome of fertility (live birth). Thus, vaginal progesterone is effective for LPS in women undergoing fresh embryo transfer.

The effect of laughter yoga and music intervention on depression, anxiety, and stress in the Rafsanjan-Iran aged: a randomized clinical trial study

Objectives This study aimed to compare the effects of laughter yoga and music intervention on depression, anxiety, and stress in aged individuals referred to Rafsanjan health centers. Method In this 3-arm randomized clinical trial, 91 depressed aged participants aged 60–75 years, referred to Rafsanjan health centers, were randomly assigned to intervention and control groups. The study followed a parallel group design with an allocation ratio of 1:1. The laughter yoga intervention was conducted twice a week for eight weeks, and music intervention consisted of 30-min sessions twice a week for eight weeks. The control group received no intervention (‘No treatment’ concurrent control). Assessments for depressive symptoms (primary outcome), anxiety, and stress were conducted at baseline, post-intervention, and one month after the intervention. Results A total of 84 patients were analyzed in three groups included the laughter yoga intervention (n = 31), music intervention (n = 25), or control group (n = 28). Repeated measures ANOVA revealed a significant decrease in depressive and anxiety symptoms (p < 0.001) from pre-test to post-test and one-month follow-ups. The greatest impact of the intervention programs on stress was observed immediately after the intervention, but stress increased one month after the intervention programs (p = 0.125). Conclusion Both laughter yoga and music interventions proved effective in improving depression, anxiety, and stress in aged individuals. However, laughter yoga intervention demonstrated a superior effect and better acceptance among elders.

Efficacy of adjuvant photobiomodulation therapy in recurrent herpes labialis, a randomized clinical trial study

ObjectiveThis study aimed to determine the effect of Photobiomodulation therapy (PBMT) in the treatment of recurrent herpes labialis (RHL), one of the most common herpes simplex virus type 1 infections. Material and MethodsIn this randomized double blind controlled trial, Twenty-two symptomatic patients with RHL were enrolled. The patients were randomly allocated into one group (5 % acyclovir cream with 940±10 nm wavelength and 4 J/cm2 energy density and 100 mW output power) and another group (5 % Acyclovir 5 times/5 days and sham laser). Lesion size, and pain intensity were considered as the outcome at baseline, 1st 2nd and 3rd days postoperatively. ResultsPain intensity in PBM + Acyclovir group was significantly lower than Acyclovir without PBM group in both two and three days after intervention (p < 0.001). The lesion size in case group was significantly lower on 7 and 10 days (p < 0.05). Patients in the treatment group were significantly more satisfied with their treatment process (p = 0.008). ConclusionPBMT can be used as an adjuvant tool to acyclovir cream, due to higher potential in reducing postoperative pain, lesion size and also patients satisfaction.

Medication development for AUD: A systematic review of clinical trial methodology

Refining clinical trial methodology has become increasingly important as study design is shown to influence treatment efficacy. To maximize the efficiency of randomized clinical trials (RCTs), researchers aim to establish standardized practices. The goal of this systematic review is to describe methodological practices of clinical trials for alcohol use disorder (AUD) over the past 40 years. To achieve this goal, a PubMed search was conducted in April 2023 for RCTs on AUD medications published between July 2018 through April 2023. Resulting studies were combined with a previous search from 1985 through 2018. Inclusion criteria for the RCT studies were: (1) a randomized controlled trial, (2) double or single blinded, (3) placebo or active control condition, (4) alcohol use as the primary endpoint, (5) 4 or more weeks of treatment, and (6) 12 or more weeks of follow-up. In total, methodological data from 139 RCTs representing 19 medications and spanning the past four decades were summarized. Results indicated that the most common medications tested were naltrexone (k = 42), acamprosate (k = 24), and baclofen (k = 11). On average, participants were 74% male and consumed 226 drinks per month pre-randomization. The median length of treatment was 12 weeks (IQR = 12–16; min = 4 max = 52) and the median follow-up duration was 12.5 weeks (IQR: 12–26; min = 7 max = 104). There were two broad domains of outcomes (i.e., abstinence and heavy drinking), with most studies featuring outcomes from both domains (k = 87; 63%). Reporting practices were summarized by decade, revealing an increased enrollment of females, better reporting of race and ethnicity data, and less studies requiring pre-trial abstinence. This review summarizes the current state of the literature on randomized clinical trials for AUD including effect sizes for individual studies and summaries of key methodological features across this representative set of clinical trials.

The Efficacy of Ultrasound Guided Bilateral Transversus Thoracic Plane Block for Postoperative Pain Control in Cardiac Surgery

Abstract Background Cardiothoracic surgeries are associated with significant pain. Optimal analgesia is a vital part of strategies intended to improve patients' experience and outcomes. Traditionally, analgesia in these types of surgeries has depended on large doses of I.V. opioids. Aim of the Work The aim of the study was to evaluate the effect of postoperative bilateral US guided TTPB block on postoperative pain control in patients undergoing cardiac surgery through mid-line sternotomy compared to systemic analgesia. Patients and Methods This study is a randomized clinical trial study at Ain-shams University Hospitals, Cairo, Egypt. In our study, patients were randomly allocated into two groups with 40 patients in each group. Group 1 (study group) received TTP block., whereas Group 2(control group) received systemic analgesics. The two groups were compared regarding their demographic data (age, sex, body weight and height), A numerical rating scale (NRS) for sternal pain, morphin consumption during 24 hours after extubation and time of first rescue analgesia, heart rate and blood pressure in icu, time of extubation, ICU length of stay, total length stay of the hospital. Results Our study showed that when compared to general anesthesia with systemic opioids, TTPB block is associated with significantly better postoperative pain control. Conclusion Tranversus thoracic plaine block is technically simple, safe and very effective technique and can be used as a part of multimodal analgesia in postoperative cardiac surgical patients for better patient comfort and satisfaction and also helps in superior pulmonary rehabilitation, thus assisting in better outcome and less unwanted side effects of systemic analgesics.

A Comparative Study between Fascia Iliaca Block and Femoral Nerve Block for Postoperative Analgesia after Intertrochanteric Fracture Surgery

Abstract Background Intertrochanteric fracture surgery is a common orthopedic procedure worldwide, pain may be severe, and the patients generally require a significant amount of opioid-based analgesics after such procedures. Peripheral nerve blocks offer effective analgesia and decrease the need for opioids, thereby reducing the complications associated with the use of this class of drug. Pain management regimens following Intertrochanteric fracture surgery include oral analgesics, periarticular injection, peripheral nerve blocks (PNBs), and intravenous patient- controlled analgesia (PCA). Objective To compare the analgesic efficacy and functional recovery of Fascia iliaca block and FNB in patients who have undergone Hip surgery. Methods This prospective randomized clinical trial study was conducted in Ain Shams University hospital after approval of the anesthesia department and the local ethics and research committee over 6 months and after obtaining a written informed consent. Sixty patients underwent Intertrochanteric fracture surgery under spinal anaesthesia regarding postoperative pain and early ambulation were included in the study their ages range between 40 to 75 years old and classified as ASA I and II. The patients were randomly divided using computer generated randomization into two groups 30 patients in each (n = 30). Results The two groups were compared as regard pain control post operatively. Numerical rating scale (NRS) was used to assess pain post operatively and used at regular interval (PACU, After 15min., After 30min., After 45min., After 1 hr., After 1.5 hrs., After 2 hrs., After 4 hrs., After 6 hrs., After 8 hrs., After 10 hrs., After 12 hrs., After 14 hrs., After 16 hrs., After 18 hrs., After 20 hrs., After 22 hrs. and After 24 hrs.). And there is no significant difference between two groups, with p- value (p &amp;gt; 0.05 NS). As regard to total dose of narcotics used in each group, there is no difference in postoperative nalbuphine consumption. The two groups are compared as regard to quadriceps weakness, onset of ambulation and there was a significant difference between two groups. Conclusion Fascia iliaca block is more effective than Femoral Nerve Block in in patient satisfaction for post-operative analgesia and equally effective with femoral nerve block in post-operative ambulation after Intertrochanteric fracture surgery.

A Comparative Study between Ultrasound Guided Pectoral Nerve Block Type II versus Intravenous Patient Controlled Analgesia for Intra-Operative and Post-Operative Analgesia in Patients Undergoing Modified Radical Mastectomy

Abstract Background Breast surgery is becoming more and more common. Patients are often middle-aged women and with high public awareness around issues of breast cancer. The numbers are increasing. Breast surgery is an exceedingly common procedure and associated with an increased incidence of acute and chronic pain. Regional anaesthesia techniques may improve post-operative analgesia for patients undergoing breast surgery. Aim of the Work The primary aim of this study is to compare the efficacy of PECS block versus PCA with iv morphine to provide prolonged post-operative analgesia. The secondary objective is to identify the side effects of both techniques as post-operative analgesic techniques. Patients and Methods This study is a randomized clinical trial study conducted in Ain-shams University Hospitals, Cairo, Egypt for 6 months after medical ethical committee approval. The participants were allocated randomly into two groups of 25 patients each: group A: Patients received general anaesthesia followed by PECS block at the end of the operation before extubation, group B: Patients received general anaesthesia followed by the PCA at the end of surgery after extubation. Results The VAS score in the PECS group was statistically significantly lower at the 1st, 2nd and 4th hours. In this case, the use of PECS for postoperative analgesia is as effective as intravenous Morphine PCA in pain treatment, but with less systemic side effect as the nausea and vomiting is significantly higher in the PCA group than the PECS group at the 6th hour, however, the need of intra operative opioids in PCA group is significant. Conclusion In modified radical mastectomy, PECS block is as effective as intravenous Morphine PCA in pain treatment. Compared with intravenous PCA, PECS block can be considered as a more preferable method because it can avoid the systemic actions of morphine used for PCA, and can decrease the need of analgesia intra-operative, however PCA analgesic effect last longer, less invasive technique and easier to be used while PECS block require hand skills and limited to 24 hours analgesia only.

Emergence Agitation after Nasal Surgery: A Randomized Controlled Comparison between Melatonin and Mirtazapine

Abstract Background: Aim of the Work To evaluate the efficacy of melatonin versus mirtazapine administration in preventing emerging agitations in adults following nose surgery. Patients and Methods This prospective randomized clinical trial study was conducted at Ain Shams University Hospitals, Cairo, Egypt. One hundred and sixty five (165) consecutive patients scheduled for elective nasal surgery under general anesthesia where nasal packing was packed in both sides. The patients' age was above 21 years old from both genders and with the American Society of Anesthesiologists physical status classification (ASA) I or II. Results The mirtazapine category had the greatest patients` satisfactions scores 24 hours after surgery, followed by the melatonin category, while the control group had the lowest score. There were statistically significant differences between the control group and other categories, but not between the mirtazapine and melatonin groupings. Conclusion Prophylactic administration of melatonin or mirtazapine attenuated emergence agitation with minimal hazards in patients scheduled for nasal surgery under general anesthesia with priority to mirtazapine.

Ultrasound Guided Subscapularis and Subomohyoid Plane Blocks versus Interscalene Block with Levobupivacaine for Analgesia in Shoulder Surgery

Abstract Background Now Shoulder surgery is a common procedure, particularly as it is associated with reduced hospitalization times, even though the technique may lead to moderate and severe postoperative pain. In recent years, various studies have been carried out that demonstrated the need for valid anaesthetic techniques that allow adequate control of postoperative pain and also favour early mobilization and rehabilitation. Subscabularis and subomohyoid plane blocks allow pain control after shoulder surgery while decreasing the need of opioids and pain medication after surgery. In contrast to interscalene brachial plexus block, subscabularis and subomohyoid plane blocks carry minor risks of intrathecal injection or post operative respiratory distress. Aim of the Work to compare analgesic efficacy of ultrasound guided subomohyoid and subscapularis plane blocks versus interscalene block using levobupivacaine in both techniques for pain control after shoulder surgery. Patients and Methods This exploratory randomized clinical trial study was conducted in Ain Shams University hospital after approval of the anesthesia department and the local ethics and research committee over 6 months and after obtaining a written informed consent. Sixty patients underwent shoulder surgery under general anesthesia were included in the study their ages range between 21 and 65 years old and classified as ASA I and II. The patients were randomly divided using computer generated randomization and opaque sealed envelopes into two groups 30 patients in each (n = 30). Results In this study we find that combined subscapularis plane and sub-omohyoid injections may serve as an alternative to interscalene block for shoulder analgesia, with less complications. The present study shows no difference in the demographic data between the two groups (p-value &amp;gt;0.05). Also there was no statistically significant difference in the surgery duration between the two groups. But the duration of subomohyoid and subscapularis plane block was longer than the duration of interscalene block, the Mean± SD is (10.80±2.64 minutes) for subomohyoid and subscapularis plane blocks while interscalene block duration is (5.33±1.56 minutes) so there was astatically significant difference P-value &amp;lt;0.001. Conclusion Subscapularis plane and subomohyoid plane blocks can be used as an alternative shoulder analgesia with minor risks.